E.P.A.R s  Editing

Samsca

What is Samsca and what is it used for?

Samsca is a medicine for treating abnormally low levels of sodium in the blood in adults with a condition called 'syndrome of inappropriate antidiuretic hormone secretion' (SIADH).In SIADH, an excessive amount of the hormone vasopressin makes the patient produce less urine and thereby retain more water in the body, which dilutes the concentration of sodium in the blood.Samsca contains the active substance tolvaptan.

How is Samsca used?

Samsca is available as tablets (7.5, 15 and 30 mg). The starting dose is 15 mg once a day. This may be increased to a maximum of 60 mg once a day to achieve an appropriate level of blood sodium and blood volume. A dose of 7.5 mg once a day can be used for patients at risk of excessively quick rise in blood sodium.The medicine can only be obtained with a prescription. Treatment with Samsca should be started in hospital so that healthcare professionals can determine the most appropriate dose and monitor the patient's level of blood sodium and blood volume.For more information about using Samsca, see the package leaflet or contact your doctor or pharmacist.

How does Samsca work?

People with SIADH have an excessive amount of vasopressin, leading to decreased urine production and dilution of the blood. The active substance in Samsca, tolvaptan, is a 'vasopressin-2 receptor antagonist'. This means that it blocks one type of receptor (target) to which the hormone vasopressin normally attaches itself. By blocking this receptor, Samsca prevents vasopressin's effect. This increases urine production, decreasing the amount of water in the blood and increasing the blood sodium level.

What benefits of Samsca have been shown in studies?

Two studies involving 424 adults showed that Samsca is effective at increasing sodium levels in patients with low levels caused by SIADH and other conditions such as liver and heart problems. However, Samsca was more effective in patients with SIADH than in those with liver or heart problems. Normal sodium levels are between 135 and 145 mmol/l.In patients with SIADH, sodium levels, which were around 129 mmol/l at the start of treatment, rose by an average of 4.8 mmol/l by day 4 in those who took Samsca, compared with 0.2 mmol/l in those who took placebo (dummy treatment). By day 30, sodium had increased by an average of 7.4 mmol/l in patients who took Samsca, compared with 1.5 mmol/l in patients receiving placebo.

What are the risks associated with Samsca?

The most common side effects with Samsca (which may affect more than 1 patient in 10) are thirst, nausea (feeling sick) and sodium levels rising too quickly. For the full list of side effects reported with Samsca, see the package leaflet.Samsca must not be used in patients with anuria (an inability to pass urine), very low blood volume, low blood sodium levels with low blood volume, hypernatremia (abnormally high levels of sodium in the blood) or in patients who cannot perceive thirst. It must not be used in patients who are allergic to tolvaptan or medicines that are similar to tolvaptan, so-called benzazepines or their derivatives. Samsca must also not be used in women who are pregnant or breast-feeding. For the full list of restrictions, see the package leaflet.

Why is Samsca authorised in the EU?

Samsca has been shown to be effective at increasing sodium levels, particularly in patients with SIADH. The only major safety concerns seen with this medicine came from animal studies suggesting it could be harmful to unborn babies. This medicine must therefore not be used in women who are pregnant or breastfeeding.The European Medicines Agency concluded that Samsca's benefits are greater than its risks and that it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Samsca?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Samsca have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Samsca are continuously monitored. Side effects reported with Samsca are carefully evaluated and any necessary action taken to protect patients.

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Sancuso

What is Sancuso?

Sancuso is a medicine that contains the active substance granisetron. It is available as a transdermal patch (a patch that delivers a medicine across the skin). Each patch releases 3.1 mg of granisetron over 24 hours.Sancuso is a 'hybrid generic medicine'. This means that it is similar to a 'reference medicine' containing the same active substance, but given in a different way. While the reference medicine for Sancuso is Kytril taken by mouth, Sancuso is a patch applied to the skin.

What is Sancuso used for?

Sancuso is an 'anti-emetic', a medicine that prevents nausea (feeling sick) and vomiting. It is used to prevent nausea and vomiting caused by types of chemotherapy (medicines used to treat cancer) that are moderate or strong triggers of nausea and vomiting. Sancuso is only used in adults who would have difficulty swallowing medicines and when the chemotherapy lasts from three to five days.The medicine can only be obtained with a prescription.

How is Sancuso used?

One transdermal patch is applied 24 to 48 hours before chemotherapy. The patch is applied to dry, clean, healthy skin on the outer part of the upper arm or if this is not possible, it may be applied to the abdomen. The patch can remain on the skin for up to seven days depending on the duration of thechemotherapy, and it is removed a minimum of 24 hours after completing chemotherapy. The transdermal patch should not be cut into pieces.

How does Sancuso work?

The active substance in Sancuso, granisetron, is a '5HT3 antagonist'. This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut. When 5HT attaches to these receptors, it normally causes nausea and vomiting. By blocking these receptors, Sancuso prevents the nausea and vomiting that often happen after certain types of chemotherapy.

How has Sancuso been studied?

Because Sancuso is a hybrid generic, the applicant presented comparative data on the reference medicine in addition to results from its own studies.The benefit of Sancuso in the prevention of nausea and vomiting caused by chemotherapy was investigated in one main study involving a total of 641 patients. These patients were receiving chemotherapy which was a moderate or strong trigger of nausea and vomiting, lasting for several days. The study compared one Sancuso transdermal patch worn over seven days with granisetron taken by mouth once a day for the duration of the chemotherapy.The main measure of effectiveness was the number of patients who had their nausea and vomiting under control. This was defined as having no vomiting or retching (strong involuntary contractions of the stomach with the urge to vomit), no more than mild nausea and no need to take other anti-emetic medicines for quick relief after receiving chemotherapy.

What benefit has Sancuso shown during the studies?

Sancuso transdermal patch showed similar effects to granisetron given by mouth in the prevention of vomiting and nausea after chemotherapy: 60.2% of patients receiving the Sancuso transdermal patch (171 out of 284 patients) had their nausea and vomiting under control, compared with 64.8% of patients taking granisetron by mouth (193 out of 298 patients).

What is the risk associated with Sancuso?

The most common side effect with Sancuso (seen in between 1 and 10 patients in 100) is constipation. The majority of adverse reactions were mild or moderate in severity. For the full list of all side effects reported with Sancuso, see the package leaflet.Sancuso must not be used in people who are hypersensitive (allergic) to granisetron, other 5HT3 antagonists or any of the other ingredients.

Why has Sancuso been approved?

The Committee considered that Sancuso transdermal patch showed a similar benefit to granisetron taken by mouth but that it may have a slower onset of action. The CHMP considered however that Sancuso would be of benefit for patients with difficulty swallowing, who might otherwise need to be given daily intravenous injections. Therefore, the CHMP decided that Sancuso's benefits are greater than its risks and recommended that it be given marketing authorisation.Sancuso

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Saphnelo

What is Saphnelo and what is it used for?

Saphnelo is a medicine used as an add-on treatment in adults with systemic lupus erythematosus (SLE), a disease in which the immune system (the body's natural defences) attacks normal cells and tissues, causing inflammation and organ damage.Saphnelo is given to patients who have antibodies against their own cells (autoantibodies) and whose disease is still moderate to severe despite standard treatment.Saphnelo contains the active substance anifrolumab.

How is Saphnelo used?

Saphnelo can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of SLE.Saphnelo is given as an infusion (drip) into a vein. The recommended dose is 300 mg given over 30 minutes every four weeks. The doctor may interrupt or stop treatment if the patient develops reactions linked to the infusion. Patients who have previously had such reactions may be given preventive medicines before treatment.For more information about using Saphnelo, see the package leaflet or contact your doctor or pharmacist.

How does Saphnelo work?

In SLE, a protein called type I interferon (IFN) is involved in causing the immune system to attack normal cells and tissues. Type I IFN acts by attaching to a protein called type I IFN receptor.The active substance in Saphnelo, anifrolumab, is a monoclonal antibody (another type of protein) designed to attach to this receptor, thereby preventing type I IFN from binding to it. This blocks the action of type I IFN and reduces the inflammation and organ damage that occur in SLE.

What benefits of Saphnelo have been shown in studies?

Two main studies found that 300 mg of Saphnelo was more effective as an add-on to standard treatment than placebo (a dummy treatment) in reducing SLE disease activity, measured using a standard index known as BICLA. The studies involved a total of 822 adults with moderate to severe autoantibody-positive SLE who were treated with Saphnelo for one year.In the first study, disease activity decreased in 47% of patients treated with Saphnelo compared with 30% of patients who were given placebo. In the second study, disease activity decreased in 48% of patients treated with Saphnelo compared with 32% of those who received placebo.

What are the risks associated with Saphnelo?

The most common side effects with Saphnelo (which may affect more than 1 in 10 people) are upper respiratory tract (nose and throat) infection and bronchitis (inflammation of the airways in the lungs).The most common serious side effect (which may affect up to 1 in 100 people) is herpes zoster (shingles).For the full list of side effects and restrictions of Saphnelo, see the package leaflet.

Why is Saphnelo authorised in the EU?

The European Medicines Agency considered that Saphnelo used as an add-on treatment provides a modest, but clinically meaningful reduction in disease activity in patients with SLE, for whom there is a high unmet need for new therapies. As the safety of the medicine is considered acceptable, the Agency concluded that Saphnelo's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Saphnelo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Saphnelo have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Saphnelo are continuously monitored. Suspected side effects reported with the medicine are carefully evaluated and any necessary action taken to protect patients.

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Sapropterin Dipharma

What is Sapropterin Dipharma and what is it used for?

Sapropterin Dipharma is a medicine that is used to treat high blood levels of phenylalanine in adults and children of all ages with the genetic disorders phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.Patients with these disorders cannot process the amino acid phenylalanine from dietary protein. As a result, phenylalanine builds up in the blood to abnormally high levels, causing problems in the nervous system.Sapropterin Dipharma contains the active substance sapropterin and is a 'generic medicine'. This means that Sapropterin Dipharma contains the same active substance and works in the same way as a'reference medicine' already authorised in the EU called Kuvan. For more information on generic medicines, see the question-and-answer document here.

How is Sapropterin Dipharma used?

Sapropterin Dipharma is available as soluble tablets or as a powder, to be dissolved in water and drunk. The medicine can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in treating PKU and BH4 deficiency. It is important that patients continue with a diet low in phenylalanine and protein when taking Sapropterin Dipharma, and intake of phenylalanine and protein must be monitored and adjusted to make sure that blood phenylalanine levels and nutritional balance are controlled. Sapropterin Dipharma is intended for longterm use.The starting dose of Sapropterin Dipharma depends on the patient's weight. The dose is then adjusted depending on blood levels of amino acids, including phenylalanine. Sapropterin Dipharma is taken with a meal at the same time every day, preferably in the morning. For some patients with BH4 deficiency, the dose may need to be divided into 2 or 3 doses over the course of the day to get the best effect.A satisfactory response is defined as a reduction in blood phenylalanine levels of at least 30% or to a level determined by the doctor. If this has been achieved after one month, the patient is classified as a 'responder' and can continue taking Sapropterin Dipharma.SendFor more information about using Sapropterin Dipharma, see the package leaflet or contact your doctor or pharmacist.

How does Sapropterin Dipharma work?

The high levels of phenylalanine in the blood are due to a problem with the breakdown of phenylalanine through the enzyme 'phenylalanine hydroxylase'. Patients with PKU have defective versions of the enzyme, and patients with BH4 deficiency have low levels of BH4, a 'cofactor' that this enzyme needs to work properly.The active substance in Sapropterin Dipharma, sapropterin, is a synthetic copy of BH4. In patients with PKU, it works by enhancing the activity of the defective enzyme, while in patients with BH4 deficiency it replaces the missing cofactor. These actions help restore the ability of the enzyme to convert phenylalanine into tyrosine, thereby reducing phenylalanine levels in the blood.

How has Sapropterin Dipharma been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Kuvan, and do not need to be repeated for Sapropterin Dipharma.As for every medicine, the company provided data on the quality of Sapropterin Dipharma. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Sapropterin Dipharma?

Because Sapropterin Dipharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sapropterin Dipharma authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Sapropterin Dipharma has been shown to have comparable quality and to be bioequivalent to Kuvan. Therefore, the Agency's view was that, as for Kuvan, the benefits of Sapropterin Dipharma outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sapropterin Dipharma?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sapropterin Dipharma have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sapropterin Dipharma are continuously monitored. Suspected side effects reported with Sapropterin Dipharma are carefully evaluated and any necessary action taken to protect patients.

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Sarclisa

What is Sarclisa and what is it used for?

Sarclisa is a cancer medicine used together with the medicines pomalidomide and dexamethasone to treat multiple myeloma (a cancer of the bone marrow). It is given to adults who have received at least two previous treatments for their cancer, including lenalidomide and a proteasome inhibitor, and whose cancer has worsened since receiving the last treatment.Multiple myeloma is rare, and Sarclisa was designated an 'orphan medicine' (a medicine used in rare diseases) on 29 April 2014. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3141268.Sarclisa contains the active substance isatuximab.

How is Sarclisa used?

Sarclisa can only be obtained with a prescription and should be given by a healthcare professional in a clinic or hospital where severe reactions can be quickly treated. It is given by infusion (drip) into a vein and the dose depends on body weight. Treatment starts with one dose of Sarclisa a week and, after a month, continues with one dose every two weeks. Before the infusion of Sarclisa, patients may be given medicines to reduce the risk of infusion-related reactions. The doctor may slow down the infusion or stop treatment in case of infusion-related reactions.For more information about using Sarclisa, see the package leaflet or contact your doctor or pharmacist.

How does Sarclisa work?

The active substance in Sarclisa, isatuximab, is a monoclonal antibody (a type of protein) that has been designed to attach to the protein CD38, which is found in high amounts on multiple myeloma cells. By attaching to CD38 on the multiple myeloma cells, isatuximab activates the immune system (the body's natural defences) to kill the cancer cells.

What benefits of Sarclisa have been shown in studies?

A main study in 307 patients with multiple myeloma that had not improved with previous treatments showed that adding Sarclisa to pomalidomide and dexamethasone can delay worsening of the disease. In this study, patients receiving Sarclisa and pomalidomide plus dexamethasone lived for 11.5 months without their disease getting worse compared with 6.5 months for patients receiving pomalidomide plus dexamethasone.

What are the risks associated with Sarclisa?

The most common side effects with Sarclisa (which may affect more than 1 in 5 people) are neutropenia (low levels of neutrophils, a type of white blood cell), infusion reactions, pneumonia (infection of the lungs), upper respiratory tract infection (such as nose and throat infections), diarrhoea and bronchitis (inflammation of the airways in the lungs).The most common serious side effects are pneumonia and febrile neutropenia (low white blood cell counts with fever).For the full list of side effects and restrictions with Sarclisa, see the package leaflet.

Why is Sarclisa authorised in the EU?

Sarclisa used together with pomalidomide plus dexamethasone extended the time patients with multiple myeloma lived without their disease getting worse. Sarclisa's side effects are as expected for this type of medicine given with pomalidomide and dexamethasone and are considered manageable. The European Medicines Agency therefore decided that Sarclisa's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sarclisa?

The company that markets Sarclisa will provide educational material to all healthcare professionals expected to use the medicine to inform them that the medicine can affect the result of a blood test (indirect Coombs test) used to determine suitability for blood transfusions. Patients who are prescribed Sarclisa will be provided with a patient alert card with this information.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sarclisa have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sarclisa are continuously monitored. Side effects reported with Sarclisa are carefully evaluated and any necessary action taken to protect patients.

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Savene

What is Savene?

Savene is a powder and diluent that are made up into a solution for infusion (drip into a vein). It contains the active substance dexrazoxane.

What is Savene used for?

Savene is used to treat extravasation of anthracyclines (a group of anticancer medicines). Extravasation happens when an anticancer medicine that is normally injected into a vein leaks or is accidentally injected in the tissue surrounding the vein, where it can cause serious damage.Because the number of patients who have extravasation of anthracyclines is low, the condition is considered 'rare', and Savene was designated an 'orphan medicine' (a medicine used in rare diseases) on 19 September 2001.The medicine can only be obtained with a prescription.

How is Savene used?

Savene must be used under the supervision of a doctor who has experience in the use of anticancer medicines.The first infusion of Savene is given as soon as possible after the accident, and no later than six hours after it happened. Two further infusions are then given, one on day 2 and another on day 3, at thesame time as the first infusion. The infusion should last between one and two hours, and be given at a site other than where the extravasation happened.

How does Savene work?

The active substance in Savene, dexrazoxane, is an antidote to anthracyclines. The way it works is not entirely clear, but may be linked to the way the medicine attaches to iron in the body to form a 'chelate' and to its effect on some enzymes, such as topoisomerase II. Together, these effects can reduce the amount of tissue damage caused by anthracycline extravasation.Dexrazoxane has been in use since the 1990s as a medicine to help prevent the cardiomyopathy (harm to the heart muscle) associated with the use of anthracyclines.

How has Savene been studied?

Savene has been tested in two main studies involving a total of 80 patients who had extravasation of anthracyclines such as epirubicin or doxorubicin. Savene was not compared with any other medicines in these studies. The studies looked at how many patients needed surgery to correct the damage due to the extravasation.

What benefit has Savene shown during the studies?

Only one patient among the 54 in whom the effectiveness of Savene could be measured had tissue damage requiring surgery.

What is the risk associated with Savene?

The most common side effects with Savene (seen in more than 1 patient in 10) are nausea (feeling sick), and pain and infection at the site of the injection. Patients can also develop low blood levels of white blood cells and platelets. Although this may be caused by their anti-cancer treatment, it can also be caused by Savene, because it is a cytotoxic (a medicine that destroys cells that are multiplying) that can affect the bone marrow. Patients will be monitored for these side effects before, during and after treatment. For the full list of all side effects reported with Savene, see the package leaflet.Savene should not be used in people who may be hypersensitive (allergic) to dexrazoxane or any of the other ingredients. It must not be used in women who could become pregnant or who are breastfeeding, or in patients receiving vaccination against yellow fever.

Why has Savene been approved?

Anthracycline extravasation is a condition that can currently be managed using various methods, but for which there is no standard authorised treatment. The CHMP concluded that Savene had shown its ability to treat anthracycline extravasation, allowing patients to continue their anticancer treatment. The Committee decided that Savene's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Saxenda

What is Saxenda and what is it used for?

Saxenda is a medicine used along with diet and exercise to help manage weight in adults:• who are obese (have a body-mass index - BMI - of 30 or more);• who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep).BMI is a measurement that indicates body weight relative to height.Saxenda contains the active substance liraglutide.

How is Saxenda used?

Saxenda is available as a solution for injection in pre-filled pens. The medicine can only be obtained with a prescription.Saxenda is injected once per day, preferably at the same time every day. It is given as an injection under the skin in the thigh, upper arm or abdomen (belly). The starting dose is 0.6 mg per day. The dose is then increased each week by 0.6 mg to a maximum of 3.0 mg per day.Treatment with Saxenda should be stopped if patients have not lost at least 5% of their initial body weight after 12 weeks of treatment with 3 mg of Saxenda per day. The doctor should re-assess the need of continuing treatment once a year.

How does Saxenda work?

The active substance in Saxenda, liraglutide, is a 'glucagon-like peptide-1 (GLP-1) receptor agonist' that is already authorised in the EU as Victoza at lower doses (up to 1.8 mg per day) for the treatment of type 2 diabetes.The exact way that Saxenda works in weight loss is not fully understood, but it appears to act on the parts of the brain that regulate appetite, by attaching to GLP-1 receptors in brain cells and thereby increasing feelings of fullness and lowering feelings of hunger.

What benefits of Saxenda have been shown in studies?

Saxenda has been shown to be effective at reducing body weight in 5 main studies involving over 5,800 obese or overweight patients and lasting up to 56 weeks, in which Saxenda was compared with placebo (a dummy treatment). Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise.Looking at the results of the 5 studies together, Saxenda at a daily dose of 3 mg led to a 7.5% reduction in body weight, compared with a 2.3% reduction in patients taking placebo. Patients treated with Saxenda had a continuous decrease in body weight during the first 40 weeks of treatment, after which the weight loss achieved was maintained. Weight loss was more pronounced in women than in men.When the figures for the main studies were re-analysed using a more conservative method that assumed that patients who did not complete the study (around 30%) would not have seen any improvement, similar but smaller weight reductions with Saxenda were noted.

What are the risks associated with Saxenda?

The most common side effects with Saxenda (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, diarrhoea and constipation.For the full list of all side effects and restrictions with Saxenda, see the package leaflet.

Why is Saxenda approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Saxenda's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that Saxenda has a modest (particularly in men) but still clinically relevant effect on weight loss. Regarding safety, the most common side effects with Saxenda relate to the stomach and gut such as nausea. To limit these effects, when starting treatment the dose of Saxenda is slowly increased over 4 weeks. Further information on the long-term safety of liraglutide (particularly its effects on the heart and blood vessels) is expected from an ongoing study with Victoza.

What measures are being taken to ensure the safe and effective use of Saxenda?

A risk management plan has been developed to ensure that Saxenda is used as safely as possible.Based on this plan, safety information has been included in the summary of product characteristics andthe package leaflet for Saxenda, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.

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Scemblix

What is Scemblix and what is it used for?

Scemblix is a cancer medicine. It is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in the 'chronic' phase (this is when the condition is developing slowly and the patient has few or no symptoms). The medicine can be used in adult patients whose cancer is'Philadelphia-chromosome positive' (Ph+). Ph+ means that two of the patient's chromosomes have rearranged themselves and formed a special chromosome called the Philadelphia chromosome. This chromosome produces an enzyme, BCR::ABL1 kinase, that leads to the development of leukaemia.Scemblix is used in patients who have already been treated with two or more cancer medicines called tyrosine kinase inhibitors.CML is rare, and Scemblix was designated an 'orphan medicine' (a medicine used in rare diseases) on 24 March 2020. Further information on the orphan designation can be found here: https://www.ema.europa.eu/documents/orphan-designation/eu/3/20/2261-public-summary-opinionorphan-designation-asciminib-treatment-chronic-myeloid-leukaemia_en.pdf Scemblix contains the active substance asciminib.

How is Scemblix used?

Scemblix can only be obtained with a prescription and treatment must be started by a doctor who is experienced in the diagnosis and treatment of leukaemia.The medicine is available as tablets to be taken by mouth twice a day. The doctor may interrupt treatment and reduce the dose if certain side effects occur. Treatment may be stopped if a patient cannot tolerate treatment with the reduced dose.For more information about using Scemblix, see the package leaflet or contact your doctor or pharmacist.

How does Scemblix work?

The active substance in Scemblix, asciminib, is a tyrosine kinase inhibitor (TKI), meaning that it blocks enzymes known as tyrosine kinases. In Ph+ CML, the body produces large numbers of abnormal whiteblood cells. Scemblix specifically blocks the action of the BCR::ABL1 tyrosine kinase that is produced by these cells, and this stops their division and growth.

What benefits of Scemblix have been shown in studies?

The benefits of Scemblix were evaluated in a main study in 233 adults with Ph+ CML in the chronic phase who were previously treated with two or more tyrosine kinase inhibitors. In this study, Scemblix was more effective than bosutinib (another tyrosine kinase inhibitor): after 24 weeks of treatment, 25% (40 out of 157) of patients given Scemblix had a major molecular response (meaning that the number of cells with the BCR::ABL1 gene had decreased to 1,000 times below the standardised baseline), compared with 13% (10 out of 76) of patients given bosutinib. After 96 weeks of treatment, 38% (59 out of 157) of patients given Scemblix and 16% (12 out of 76) of patients given bosutinib had a major molecular response.

What are the risks associated with Scemblix?

The most common side effects with Scemblix (which may affect more than 2 in 10 people) are pain in the muscles, joints and bones, upper respiratory tract (nose and throat) infections, thrombocytopenia (low levels of blood platelets), tiredness, headache, increased levels of pancreatic enzymes, abdominal pain, diarrhoea and nausea (feeling sick).The most common serious side effects with Scemblix (which may affect up to 1 in 10 people) are pleural effusion (fluid around the lungs), lower respiratory tract infections (infections of the lungs, such as bronchitis or pneumonia), thrombocytopenia, fever, pancreatitis (inflammation of the pancreas), chest pain (not related to the heart) and vomiting.For the full list of side effects and restrictions of Scemblix, see the package leaflet.

Why is Scemblix authorised in the EU?

Scemblix has been shown to be more effective than another tyrosine kinase inhibitor at reducing the number of cells with the BCR::ABL1 gene in patients who had already received at least two previous tyrosine kinase inhibitors. In terms of safety, the side effects with Scemblix are similar to those seen with this class of medicines and are considered manageable. The European Medicines Agency therefore decided that the benefits of Scemblix are greater than its risks and that it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Scemblix?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Scemblix have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Scemblix are continuously monitored. Suspected side effects reported with Scemblix are carefully evaluated and any necessary action taken to protect patients.

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Scenesse

What is Scenesse and what is it used for?

Scenesse is an implant used to treat patients with erythropoietic protoporphyria (EPP), a rare disease that causes intolerance to light.In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light. Scenesse is used to help prevent or reduce these symptoms so that these patients can lead more normal lives.Because the number of patients with EPP is low, the disease is considered 'rare', and Scenesse was designated an 'orphan medicine' (a medicine used in rare diseases) on 8 May 2008.Scenesse contains the active substance afamelanotide.

How is Scenesse used?

Scenesse is only prescribed by specialist doctors in recognised centres for treating EPP and should only be used by doctors who have been properly trained.One Scenesse implant is injected under the patient's skin once every 2 months, before and during periods of high sunlight exposure, e.g. from spring to autumn. The number of implants per year depends on how much protection from the sun is needed. Three implants per year are recommended;the maximum number is 4. Patients should be observed for allergic reactions for 30 minutes after the injection of each implant.For more information on how to use Scenesse, see the summary of product characteristics (also part of the EPAR).

How does Scenesse work?

The active substance in Scenesse, afamelanotide, is similar to a hormone in the body known as alphamelanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin. This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells.Patients with EPP have high levels of a substance called protoporphyrin IX in the body.Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition. By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.

What benefits of Scenesse have been shown in studies?

Scenesse has been shown in a study to lead to an increase in the amount of time patients can spend in sunlight. In the study, involving 93 patients with EPP, patients were treated with either Scenesse or a placebo (a dummy treatment) over a six-month period. Daily records of exposure to sunlight between 10 am and 6 pm showed that patients treated with Scenesse spent on average 116 hours in direct sunlight without experiencing pain during the six-month period compared with 61 hours for patients treated with placebo.

What are the risks associated with Scenesse?

The most common side effects seen in studies with Scenesse were nausea (feeling sick), headache and reactions at the implant site (such as discoloration, pain and redness). These affected around 1 in 5 patients and were generally mild in severity.Scenesse must not be used in patients with reduced liver or kidney function. For the full list of all side effects and restrictions with Scenesse, see the package leaflet.

Why is Scenesse approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Scenesse's benefits are greater than its risks and recommended that it be given marketing authorisation. The CHMP noted that Scenesse led to an increase in the amount of time patients could spend in direct sunlight without experiencing pain. Although the additional time spent in sunlight was small, the Committee considered the possible improvements in quality of life, the unmet medical need in patients with EPP, and the mild side effects seen during short-term treatment with the medicine in deciding to recommend approval for Scenesse in the EU. The Committee also consulted individual patients and experts on their experience with Scenesse.Scenesse has been authorised under 'exceptional circumstances'. This is because it has not been possible to obtain complete information about the benefits of Scenesse, in part due to the rarity of the disease. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Scenesse?

Since Scenesse has been approved under exceptional circumstances, the company that markets Scenesse will provide longer-tem data on the benefits and safety of the medicine from an EU registry of patients taking the medicine.

What measures are being taken to ensure the safe and effective use of Scenesse?

A risk management plan has been developed to ensure that Scenesse is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scenesse, including information on the appropriate precautions to be followed by healthcare professionals and patients.In addition, the company that markets Scenesse will ensure that doctors receive educational material and are trained in how to use the medicine. Doctors will also be given information on the EU registry.Further information can be found in the summary of the risk management plan.

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Scintimun

What is Scintimun?

Scintimun is a kit for the preparation of a radioactive solution for injection. It contains the active substance besilesomab.

What is Scintimun used for?

Scintimun is not used on its own, but must be radiolabelled before use. Radiolabelling is a technique where a substance is labelled with a radioactive compound. Scintimun is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).Scintimun is for diagnostic use only. It is used to locate areas of infection or inflammation in adults with suspected osteomyelitis (bone infection) in the limbs, in combination with other appropriate imaging methods.Scintimun should not be used to diagnose diabetic foot infection (infection that occurs in the feet of patients with diabetes).The medicine can only be obtained with a prescription.

How is Scintimun used?

Scintimun should only be used in hospitals with a nuclear medicine department and should only be handled by authorised staff.A radioactive Scintimun solution is made by mixing the powder and solvent provided in the kit and then radiolabelling it with technetium (99mTc). The solution is given to the patient as one injection into a vein. The amount of besilesomab injected varies between 0.25 to 1 mg, depending on how much radioactivity is required.Three to six hours after the injection, the doctor takes a scan of the limbs to locate the areas in the bones affected by osteomyelitis.

How does Scintimun work?

The active substance in Scintimun, besilesomab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Besilesomab has been designed to attach to an antigen called NCA-95, which is found on the surface of granulocytes, a type of white blood cell involved in inflammation and fighting infection.When Scintimun is radiolabelled, the radioactive compound technetium (99mTc) becomes attached to besilesomab. When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes. As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate in areas affected by osteomyelitis, where it can be detected by scans. The images will show where besilesomab has accumulated, which the doctor will use to locate the areas of infection or inflammation.

How has Scintimun been studied?

In one main study in 130 patients who had or were suspected to have osteomyelitis in their limbs, radiolabelled Scintimun was compared with a standard diagnostic technique using the patients' own white blood cells that were radiolabelled before being injected back into the patient. Patients limbs were then scanned and the images obtained using both techniques were compared. The main measure of effectiveness for Scintimun was based on how much the assessment of the images obtained with Scintimun agreed with that obtained with the radiolabelled white blood cells.

What benefit has Scintimun shown during the studies?

Scintimun produced comparable results to the radiolabelled white blood cells when used to diagnose and locate osteomyelitis in limbs. The agreement rate was 83%.

What is the risk associated with Scintimun?

The most common side effect with Scintimun (seen in more than 1 patient in 10) is the production of anti-mouse antibodies. For the full list of all side effects reported with Scintimun, see the package leaflet. Scintimun must not be used in people who are hypersensitive (allergic) to besilesomab, to other mouse antibodies or to any of the other ingredients. Scintimun must not be used in patients who have tested positive for human anti-mouse antibody (HAMA) and must not be used in pregnant women. As for all radioactive substances used in medicine, patients should be exposed to the lowest possible dose of Scintimun.

Why has Scintimun been approved?

The CHMP decided that Scintimun's benefits are greater than its risks. The Committee recommended that Scintimun be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Scintimun?

A risk management plan has been developed to ensure that Scintimun is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scintimun, including the appropriate precautions to be followed by healthcare professionals and patients.In addition the company that makes Scintimun will make sure that all doctors who are expected to use it are provided with a letter explaining the risks associated with the medicine.

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Seebri Breezhaler

What is Seebri Breezhaler and what is it used for?

Seebri Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Seebri Breezhaler is used for maintenance (regular) treatment.Seebri Breezhaler contains the active substance glycopyrronium bromide.

How is Seebri Breezhaler used?

Seebri Breezhaler capsules, which contain a powder for inhalation, are only used with the Seebri Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.The recommended dose is one capsule once a day at the same time each day. Patients should not use more than one capsule in a day.Seebri Breezhaler can only be obtained with a prescription.For more information about using Seebri Breezhaler, see the package leaflet or contact your doctor or pharmacist.

How does Seebri Breezhaler work?

The active substance in Seebri Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist. This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs. Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways. This helps to keep the airways open and allows the patient to breathe more easily.

What benefits of Seebri Breezhaler have been shown in studies?

Seebri Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD. In both studies,Send a qthe main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).After 12 weeks of treatment, Seebri Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.

What are the risks associated with Seebri Breezhaler?

The most common side effects with Seebri Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting). For the full list of all side effects and restrictions with Seebri Breezhaler, see the package leaflet.

Why is Seebri Breezhaler authorised in the EU?

The European Medicines Agency noted that Seebri Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD. The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment. In addition, there were no major safety concerns with Seebri Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines. Therefore, the Agency decided that Seebri Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe use of Seebri Breezhaler?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Seebri Breezhaler have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Seebri Breezhaler are continuously monitored. Side effects reported with Seebri Breezhaler are carefully evaluated and any necessary action taken to protect patients.

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Seffalair Spiromax

What is Seffalair Spiromax and what is it used for?

Seffalair Spiromax is a medicine used for the regular treatment of asthma in adults and adolescents above 12 years of age. It is used in patients whose disease is not adequately controlled despite treatment with a combination of a short-acting beta-2 agonist and inhaled corticosteroid. It contains the active substances salmeterol and fluticasone.

How is Seffalair Spiromax used?

The medicine can only be obtained with a prescription. It is available as an inhalation powder in an inhaler device.It comes in two strengths, one containing 12.75 micrograms of salmeterol and 100 micrograms of fluticasone and a higher strength (containing 12.75 micrograms of salmeterol and 202 micrograms of fluticasone).Patients use one inhalation twice a day (one in the morning and one in the evening); the doctor will decide which strength is appropriate (and change it when necessary) based on how severe the asthma is and how well it has been controlled. Once the asthma is controlled doctors should consider changing patients to inhaled corticosteroid alone.Patients should be shown how to use the inhaler correctly by a doctor or other healthcare professional.The delivered doses for Seffalair Spiromax are different from other salmeterol / fluticasone containing products. Seffalair Spiromax should therefore not be swapped with other salmeterol / fluticasone containing inhalers.For more information about using Seffalair Spiromax, see the package leaflet or contact your doctor or pharmacist.

How does Seffalair Spiromax work?

The two active substances in Seffalair Spiromax are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.Salmeterol is a long-acting beta-2 agonist. It attaches to beta-2 receptors in the muscles of the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.Fluticasone is a corticosteroid. It reduces the activity of the immune system by attaching to receptors in various types of immune cells, blocking the release of substances involved in the inflammation process. This reduces inflammation in the airways and improves the patient's breathing.

What benefits of Seffalair Spiromax have been shown in studies?

Two main studies in 1,375 patients with asthma have shown that Seffalair Spiromax is effective at improving patients' FEV1 (the maximum volume of air they can breathe out in one second).In the first study, patients treated with Seffalair Spiromax (containing 12.75 micrograms of salmeterol and 100 micrograms of fluticasone) for 12 weeks had FEV1 increases of 315 ml, compared with 204 ml for patients treated with a comparable dose of inhaled fluticasone, and 53 ml for patients treated with placebo.In the second study, patients treated with Seffalair Spiromax (containing 12.75 micrograms of salmeterol and 100 micrograms of fluticasone) had FEV1 increases of 271 ml, compared with 119 ml for patients treated with a comparable dose of inhaled fluticasone, and a decrease of 4 ml for patients treated with placebo. For the higher strength Seffalair Spiromax FEV1 increases were 272 ml, compared with 179 ml for patients treated with a comparable dose of inhaled fluticasone.

What are the risks associated with Seffalair Spiromax?

The most common side effects with Seffalair Spiromax (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache, cough and oral candidiasis (thrush, a fungal infection).For the full list of side effects and restrictions of Seffalair Spiromax, see the package leaflet.

Why is Seffalair Spiromax authorised in the EU?

Seffalair Spiromax improves breathing in patients with asthma. It contains two active substances which are well known and already marketed as combination inhalers. The safety profile of Seffalair Spiromax is considered similar to that of other similar inhaler medicines. The European Medicines Agency decided that Seffalair Spiromax's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Seffalair Spiromax?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Seffalair Spiromax have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Seffalair Spiromax are continuously monitored. Side effects reported with Seffalair Spiromax are carefully evaluated and any necessary action taken to protect patients.

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Segluromet

What is Segluromet and what is it used for?

Segluromet is a medicine used to treat adults with type 2 diabetes together with diet and exercise.Segluromet can be used alone or together with other diabetes medicines when glucose (sugar) levels in the blood are insufficiently controlled by other metformin-based treatments.It can also be used as a replacement in patients who are already taking ertugliflozin and metformin as separate tablets.Segluromet contains two active substances, ertugliflozin and metformin.

How is Segluromet used?

Segluromet is available as tablets. The dose depends on how well the patient's glucose levels are controlled.The doctor will check how well the patient's kidneys are working before treatment and once a year during treatment. The dose of Segluromet may be reduced or it may be stopped if the kidneys are not working well enough. Treatment will not be started if the kidney function is too poor.For more information about using Segluromet, see the package leaflet or contact your doctor or pharmacist. Segluromet can only be obtained with a prescription.

How does Segluromet work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The result is a high level of glucose in the blood.The two active substances in Segluromet, ertugliflozin and metformin, work in different ways to lower glucose levels.Ertugliflozin helps to lower glucose in the blood by making the patient pass out glucose in the urine. It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.Metformin, on the other hand, works mainly by blocking glucose production in the body and by reducing the uptake of glucose in the gut.

What benefits of Segluromet have been shown in studies?

Four main studies in over 3,600 patients with type 2 diabetes have shown that adding ertugliflozin to metformin helps lower glucose levels when metformin is not working well enough. The studies looked mainly at effects on levels of HbA1c (a measure of blood glucose) after six months or one year of treatment. At the start of the studies, patients' HbA1c level was above 7 percentage points. The results were as follows:• The first study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with reductions of 0.03 when placebo (a dummy treatment) was added to metformin.• A second study found that adding ertugliflozin to a combination of sitagliptin (another diabetes medicine) and metformin was more effective than placebo. HbA1c levels fell by between 0.8 and0.9 percentage points when ertugliflozin was added, compared with a fall of 0.1 with placebo.• A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about as effective as a combination of metformin with another diabetes medicine, glimepiride. In this study, HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride. A lower dose of ertugliflozin 5 mg was less effective.• The fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as adding sitagliptin, with HbA1c levels falling by around 1 point with both treatments. HbA1c levels fell by a further 0.5 points when both medicines were added to metformin.In addition to lowering glucose levels, studies showed that adding ertugliflozin to metformin helped reduce patients' bodyweight and risk of heart failure.

What are the risks associated with Segluromet?

The most common side effects with Segluromet (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system, urinary tract infections, and problems with the gut such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.Segluromet must not be used in patients with uncontrolled diabetes with severe symptoms that lead to high acid levels in the blood. It must also not be used in patients with severe kidney problems or certain heart, circulatory, breathing or liver problems and in patients who drink alcohol to excess.For the full list of side effects and restrictions with Segluromet, see the package leaflet.

Why is Segluromet authorised in the EU?

The European Medicines Agency concluded that Segluromet's benefits are greater than its risks and it can be authorised for use in the EU.The Agency considered that Segluromet can be used to treat patients with type 2 diabetes, on its own and in combination with other diabetes medicines. In addition, Segluromet can help some patients loseweight and may reduce the risk of heart failure. Because ertugliflozin has less effect on blood sugar in patients whose kidney function is reduced, combining Segluromet with other medicines that lower blood sugar may need to be considered in such patients.

What measures are being taken to ensure the safe and effective use of Segluromet?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Segluromet have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Segluromet is continuously monitored. Side effects reported with Segluromet are carefully evaluated and any necessary action taken to protect patients.

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Selincro

What is Selincro?

Selincro is medicine that contains the active substance nalmefene. It is available as tablets (18 mg).

What is Selincro used for?

Selincro is used to help reduce alcohol consumption in adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women).It should only be used together with psychosocial support (counselling) and only in people who do not have physical withdrawal symptoms and who do not require immediate detoxification.As a guide: a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.Selincro can only be obtained by prescription.

How is Selincro used?

Before starting treatment with Selincro, the patient is asked to record their level of alcohol consumption over a two week period.At the patient's initial visit to their doctor, the patient's overall health, alcohol dependence, and level of alcohol consumption (based on patient reporting) will be evaluated. Thereafter, the patient will be asked to record his or her alcohol consumption for approximately two weeks.At the next visit (after the two weeks), Selincro may be started if the patient continues to have a high level of alcohol consumption (above 60 g per day for men and 40 g per day for women).Treatment must also include counselling to help the patient reduce their drinking and keep to their treatment.The patient should take one Selincro tablet by mouth 'as needed', which means when there is a risk that they would start drinking. Only one tablet can be taken on any given day and it should preferably be taken one to two hours before they are likely to start drinking. If the patient has started drinking without Selincro, a tablet should be taken as soon as possible.Data on the use of Selincro from standard clinical studies are available for a period of six months to one year. Caution is advised if Selincro is prescribed for more than one year.

How does Selincro work?

The active substance in Selincro, nalmefene, attaches to certain opioid receptors in the brain. Opioid receptors play a role in addiction and, by attaching to them and modifying their activity, nalmefene helps reduce the urge to drink in people accustomed to large amounts of alcohol.Selincro does not prevent the intoxicating effects of alcohol.

How has Selincro been studied?

The effects of Selincro were first tested in experimental models before being studied in humans.Selincro was compared with placebo (a dummy treatment) in two main studies involving 1,322 men and women with alcohol dependence. All patients also received counselling to help them reduce their drinking and keep to their treatment.The main measures of effectiveness were the reduction in the number of heavy drinking days and the average daily alcohol consumption after six months of treatment.

What benefit has Selincro shown during the studies?

Selincro was shown to be more effective than placebo in reducing the number of heavy drinking days and daily alcohol consumption.Significant improvements, usually observed within the first four weeks of treatment, were seen in patients who were already consuming more than 60 g of alcohol per day (for men) or more than 40 g of per day (for women). In these patients, after six months, the number of heavy drinking days a month with Selincro fell from 23 to 10 in the first study and from 23 to 11 in the second. Daily alcohol consumption with Selincro fell from 102 g to 44 g in the first study and from 113 g to 43 g in the second. These improvements were better than those seen with placebo by about 2.7 to 3.7 heavy drinking days a month and about 10 to 18 g of alcohol a day.

What is the risk associated with Selincro?

The most common side effects (seen in more than 1 patient in 10) were nausea (feeling sick), dizziness, insomnia (difficulty sleeping) and headache. The majority of these reactions were mild or moderate and of short duration.Selincro must not be used in people who are hypersensitive (allergic) to nalmefene or any of its other ingredients. It must not be used in patients taking opioid medicines, in patients who have a current orSelincrorecent addiction to opioids, patients with acute opioid withdrawal symptoms, or in patients suspected to have used opioids recently.It must also not be used in patients with severe liver or kidney impairment or a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures (fits) and tremors).

Why has Selincro been approved?

The CHMP noted that Selincro was shown to be effective in reducing alcohol consumption in men drinking more than 60 g and women drinking more than 40 g a day. With regard to safety, the side effects reported in the studies did not raise any major concerns. The CHMP decided that Selincro's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Semglee

What is Semglee and what is it used for?

Semglee is a medicine used to treat diabetes in patients from 2 years of age. It contains the active substance insulin glargine.Semglee is a 'biosimilar medicine'. This means that Semglee is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Semglee is Lantus. For more information on biosimilar medicines, see here.

How is Semglee used?

Semglee is available in pre-filled disposable pens and can only be obtained with a prescription. It is given by injection under the skin in the belly, the thigh, or the upper arm.Semglee is used once a day at the same time each day. The dose of Semglee is worked out for each patient and depends on the patient's blood glucose (sugar) level and treatment with other insulin medicines. Semglee can also be used with diabetes medicines taken by mouth in patients who have type 2 diabetes.Patients can inject themselves with Semglee if they have been trained appropriately.For more information about using Semglee, see the package leaflet or contact your doctor or pharmacist.

How does Semglee work?

Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes). Semglee is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.Insulin glargine, the active substance in Semglee, enters the bloodstream more slowly than human insulin after injection and so it works for longer.

What benefits of Semglee have been shown in studies?

Extensive laboratory studies comparing Semglee with Lantus have shown that insulin glargine inSemglee is highly similar to that in Lantus in terms of chemical structure, purity and biological activity. Additional studies showed that Semglee is absorbed into the body in the same way as the reference medicine, Lantus, and could be considered to act similarly on blood glucose.Because Semglee is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine. However, a supportive study in 558 patients with type 1 diabetes showed Semglee and Lantus had similar effects. Patients in the study had previously had their level of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled, brought under control with Lantus; continuing treatment with either Semglee or Lantus for 24 weeks indicated comparable control of HbA1c levels with both, the level changing by an average of 0.14% in patients given Semglee, and 0.11% in those given Lantus.

What are the risks associated with Semglee?

The most common side effect with Semglee (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose). For the full list of side effects and restrictions with Semglee, see the package leaflet.

Why is Semglee authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Semglee has been shown to have a comparable quality, safety and effectiveness to Lantus. Therefore, the Agency's view was that, as for Lantus, the benefit of Semglee outweighs the identified risk and it can be authorised in the EU.

What measures are being taken to ensure the safe and effective use of Semglee?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Semglee have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Semglee is continuously monitored. Side effects reported with Semglee are carefully evaluated and any necessary action taken to protect patients.

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Senshio

What is Senshio and what is it used for?

Senshio is a medicine used to treat moderate to severe symptoms of vulvovaginal atrophy (dryness, irritation and soreness around the genital area, and painful sexual intercourse) in women who have been through menopause.Senshio contains the active substance ospemifene.

How is Senshio used?

Senshio is available as tablets (60 mg). The recommended dose is one tablet once a day taken with food and at the same time each day.The medicine can only be obtained with a prescription.For more information about using Senshio, see the package leaflet or contact your doctor or pharmacist.

How does Senshio work?

Oestrogen hormones help to maintain the health of tissue in and around the vagina. As the levels of oestrogen hormones fall during menopause, the vaginal lining may become thin and dry. This can cause irritation and soreness and make sexual intercourse painful. The active substance in Senshio, ospemifene, is a selective oestrogen receptor modulator (SERM). This means that it acts in the same way as oestrogen in some tissues in the body such as the vagina and so helps to reduce symptoms of vulvovaginal atrophy. However, ospemifene does not work in the same way in other tissues such as the breast and womb, where such activity could cause hyperplasia (growth) of tissues which could lead to cancer.

What benefits of Senshio have been shown in studies?

Senshio has been compared with placebo (a dummy treatment) in two main studies involving over 1,700 postmenopausal women with vulvovaginal atrophy. The main measure of effectiveness was related to the change in symptoms such as pain associated with sexual activity and vaginal dryness, using a validated questionnaire. Women also received non-hormonal vaginal lubricant for use as needed. In the first study, 66% of women using Senshio reported relief from vaginal dryness (mild or no symptoms) after 12 weeks treatment compared with 49% in the placebo group. In the second study, 62% of women using Senshio reported relief from vaginal dryness after 12 weeks (compared with 53% in the placebo group). Regarding pain during sexual activity, 58% of women using Senshio reported relief in the first study (compared with 42% receiving placebo) and 63% reported relief during the second study (compared with 48% receiving placebo). The studies also showed that Senshio was effective in restoring the vaginal environment including its acidity and thickness of the lining.

What are the risks associated with Senshio?

The most commonly reported side effects with Senshio (affecting up to 1 in 10 people) are vulvovaginal candidiasis and other mycotic (fungal) infections, hot flushes, headache, muscle spasms, mild vaginal bleeding, vaginal and genital discharge, and rash.Some women must not use Senshio, including those who have or have had problems with blood clots in veins such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye). Senshio must also not be used in women who have breast cancer or another cancer that is sex hormone-dependent such as endometrial cancer (cancer of the womb). In addition, it must not be used in patients with unexplained vaginal bleeding or patients with endometrial hyperplasia (abnormal thickening of the lining of the womb).For the full list of side effects and restrictions of Senshio, see the package leaflet.

Why is Senshio approved?

The European Medicines Agency decided that Senshio's benefits are greater than its risks and it can be authorised for use in the EU. Senshio improved symptoms of vulvovaginal atrophy in postmenopausal women. The Agency noted that the degree of improvement with Senshio was comparable to that with oestrogen treatments that are applied to the vagina. Since Senshio is given by mouth the Agency considered that this medicine is a valuable alternative to local treatment. In addition, the Agency considered that the safety profile of Senshio was in line with medicines working in a similar way (SERMs).

What measures are being taken to ensure the safe and effective use of Senshio?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Senshio have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Senshio are continuously monitored. Side effects reported with Senshio are carefully evaluated and any necessary action taken to protect patients.

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Sevelamer Carbonate Winthrop

What is Sevelamer carbonate Winthrop and what is it used for?

Sevelamer carbonate Winthrop is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:• adult patients on dialysis (a technique to remove unwanted substances from the blood);• adults and children from 6 years of age with chronic (long-term) kidney disease.Sevelamer carbonate Winthrop should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.It contains the active substance sevelamer carbonate.

How is Sevelamer carbonate Winthrop used?

Sevelamer carbonate Winthrop is available as tablets (800 mg) and as powder (800 mg and 2.4 g) to be taken 3 times a day with meals.The dose to take depends on the patient's level of blood phosphate and, for children, their height and weight. Sevelamer carbonate Winthrop must not be taken on an empty stomach and patients should keep to their prescribed diets.The medicine can only be obtained with a prescription. For more information about using Sevelamer carbonate Winthrop, see the package leaflet or contact your doctor or pharmacist.

How does Sevelamer carbonate Winthrop work?

The active substance in Sevelamer carbonate Winthrop, sevelamer carbonate, is a phosphate binder. When taken with meals, it attaches in the gut to phosphate from the food, thereby preventing the phosphate from being absorbed into the body and helping to reduce phosphate levels in the blood.1 Previously known as Sevelamer carbonate Zentiva.

What benefits of Sevelamer carbonate Winthrop have been shown in studies?

Sevelamer carbonate Winthrop has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.In two main studies in 110 adults with kidney disease who were on dialysis, Sevelamer carbonate Winthrop brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another approved medicine Renagel.In a third main study in 49 adults who were not on dialysis, Sevelamer carbonate Winthrop reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.Finally, a main study also showed that Sevelamer carbonate Winthrop was effective at lowering phosphate levels in 100 children: children who took Sevelamer carbonate Winthrop had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.

What are the risks associated with Sevelamer carbonate Winthrop?

The most common side effects with Sevelamer carbonate Winthrop (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation. For the full list of side effects of Sevelamer carbonate Winthrop, see the package leaflet.Sevelamer carbonate Winthrop must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut). For the full list of restrictions, see the package leaflet.

Why is Sevelamer carbonate Winthrop approved?

Studies show that Sevelamer carbonate Winthrop is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable. The European Medicines Agency therefore decided that Sevelamer carbonate Winthrop's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sevelamer carbonate Winthrop?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sevelamer carbonate Winthrop have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sevelamer carbonate Winthrop are continuously monitored. Side effects reported with Sevelamer carbonate Winthrop are carefully evaluated and any necessary action taken to protect patients.

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Shingrix

What is Shingrix and what is it used for?

Shingrix is a vaccine used in adults aged 50 years and over to protect against shingles (herpes zoster) and post-herpetic neuralgia (long-lasting nerve pain following shingles). It can also be used from the age of 18 years and over in adults who are at increased risk of herpes zoster.Shingles is a painful, blistering rash caused by the reactivation of the virus that causes chickenpox. After a patient has had chickenpox, the virus can lie dormant in the nerves and become active again if the immune system (the body's natural defences) weakens due, for example, to ageing or to an illness.Shingrix contains a protein (glycoprotein E) from varicella zoster virus, the virus that causes chickenpox.

How is Shingrix used?

Shingrix can only be obtained with a prescription and should be used according to official recommendations. It is available as a powder and a suspension to be mixed together by a doctor or a nurse before being injected into the upper arm muscle.The vaccination course consists of 2 injections given 2 months apart. If necessary, the second dose can be given later but within 6 months after the first dose. People whose immune system does not work properly and who would benefit from a shorter vaccination schedule can have the second dose one to two months after the first dose.For more information about using Shingrix, see the package leaflet or contact your doctor or pharmacist.

How does Shingrix work?

Shingrix has been designed to prevent shingles in people who have been in contact with the varicella zoster virus and have already developed antibodies against the virus.Shingrix contains small amounts of a surface antigen (protein from the surface) of the virus to stimulate the body to make antibodies against the virus. It also contains an 'adjuvant' which is made of substances to help strengthen the immune responses to the vaccine.Patients given Shingrix will be able to produce antibodies against the virus more quickly when the virus is reactivated and they will therefore have protection against the disease.

What benefits of Shingrix have been shown in studies?

Shingrix has been shown in two main studies to be effective at preventing shingles and post-herpetic neuralgia in patients 50 years and older.In the first study, 7,695 received Shingrix and 7,710 received placebo (a dummy treatment). After just over 3 years on average, 6 adults had had shingles in the Shingrix group compared with 210 in the placebo group. After almost 4 years, nobody had had post-herpetic neuralgia in the Shingrix group compared with 18 in the placebo group. This indicates that Shingrix prevented 97% of shingles cases and 100% of cases of post-herpetic neuralgia in this study.The second study involved adults aged 70 and over who received either Shingrix or placebo. Looking at the results for adults in this age group from both studies together, 25 adults out of 8,250 who received Shingrix had shingles within 4 years after vaccination compared with 284 out of 8,346 who received placebo. After 4 years, 4 adults had had post-herpetic neuralgia in the Shingrix group compared with 36 in the placebo group. This indicates that Shingrix prevented 91% of shingles cases and 89% of cases of post-herpetic neuralgia in adults aged 70 years and older.Shingrix was also effective in two studies in adults aged 18 years and above at increased risk of developing herpes zoster. In the first study, involving people who had received an autologous (from the patient's own body) stem cell transplant, the number of people who had herpes zoster was 49 (out of 870) in the Shingrix group compared with 135 (out of 851) in the placebo group; in the second study, involving patients with blood cancer, these figures were 2 (out of 259 people) and 14 (out of 256), respectively. These studies indicate that Shingrix prevented 68% and 87% of cases, respectively.

What are the risks associated with Shingrix?

The most common side effects with Shingrix (which may affect more than 1 in 10 people) are reactions at the site of injection (such as pain, redness and swelling), chills, fever, muscle pain, tiredness, headache and side effects of the digestive system such as nausea, vomiting, diarrhoea and stomach pain. Most of these reactions last for 2 to 3 days.For the full list of side effects and restrictions with Shingrix, see the package leaflet.

Why is Shingrix authorised in the EU?

Shingrix has been shown to be highly effective at preventing shingles and post-herpetic neuralgia in adults older than 50 years for at least 4 years after vaccination. The vaccine is also effective at protecting adults older than 18 years who are at increased risk of herpes zoster. Side effects related to the use of Shingrix seemed to be mostly temporary and were manageable with standard care.The European Medicines Agency therefore decided that Shingrix's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Shingrix?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Shingrix have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Shingrix is continuously monitored. Side effects reported with Shingrix are carefully evaluated and any necessary action taken to protect patients.

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Sialanar

What is Sialanar and what is it used for?

Sialanar is a medicine for treating severe drooling of saliva in children and adolescents (aged 3 years and above) with conditions affecting the nervous system, such as cerebral palsy, epilepsy and neurodegenerative diseases. It contains the active substance glycopyrronium bromide.

How is Sialanar used?

Sialanar is available as a solution to be taken by mouth three times a day, one hour before or two hours after meals. The starting dose depends on the patient's body weight. The dose is then adjusted according to how the patient responds to the medicine and its side effects.Sialanar should be prescribed by a doctor with experience in treating children with nervous system conditions and it can only be obtained with a prescription.

How does Sialanar work?

The active substance in Sialanar, glycopyrronium bromide, blocks receptors in the salivary glands known as muscarinic receptors. These receptors trigger the production of saliva when activated by nerves from the brain. By blocking the receptors, the medicine is expected to help reduce the amount of saliva produced by the glands and so reduce drooling.

What benefits of Sialanar have been shown in studies?

Two published studies showed that glycopyrronium bromide was effective at reducing drooling in children and adolescents with nervous system conditions, using a standard rating scale known as mTDS (where a score of 1 means no drooling and a score of 9 means profuse drooling).In one of the studies in 38 children and adolescents with severe drooling, around 74% of those taking glycopyrronium bromide after 8 weeks had their scores reduced by 3 points or more compared with 18% of those taking placebo (a dummy treatment).The second study involved 27 children and adolescents with severe drooling who took either glycopyrronium bromide or placebo for 8 weeks and then had their treatment switched for another 8 weeks. This study focused on the average final drooling scores after 8 weeks of treatment, which were 1.9 in patients on glycopyrronium bromide and 6.3 in patients on placebo.

What are the risks associated with Sialanar?

The most common side effects with Sialanar (which may affect more than 1 in 10 people) are irritability, flushing, blocked nose, reduced secretions in the airways, dry mouth, constipation, diarrhoea, vomiting and inability to completely empty the bladder (urinary retention). For the full list of all side effects reported with Sialanar, see the package leaflet.Sialanar must not be used in patients with glaucoma (an eye condition), urinary retention, severe kidney impairment or a history of certain intestinal conditions or myasthenia gravis (a condition affecting muscles). It must also not be used in patients who are pregnant or are taking potassium chloride tablets or capsules or medicines which have anticholinergic effect. For the full list of restrictions with Sialanar, see the package leaflet.

Why is Sialanar approved?

Glycopyrronium bromide is well established in the EU as a treatment for drooling, and published studies show that it is effective in treating severe drooling in children and adolescents with nervous system conditions which can affect their quality of life. With regard to its risks, the side effects that occur with glycopyrronium bromide can be managed by adequately monitoring patients and adjusting the dose.The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that benefits of Sialanar outweigh its risks and recommended that it be granted marketing authorisation in the EU.

What measures are being taken to ensure the safe and effective use of Sialanar?

To help prescribers and carers use the medicine as safely as possible, the company that markets Sialanar will provide them with educational material containing information on how to use the medicine properly and manage its side effects.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sialanar have also been included in the summary of product characteristics and the package leaflet.Sialanar

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Sibnayal

What is Sibnayal and what is it used for?

Sibnayal is a medicine used to treat patients from the age of one year with distal renal tubular acidosis (dRTA), a disease in which the kidneys do not remove acid through the urine well enough. This results in a build-up of acid in the blood, which leads to a range of symptoms including hearing and growth problems, vomiting, kidney stones and lack of alertness. The disease also causes levels of potassium in the blood to fall, which can lead to muscle weakness and paralysis.Sibnayal contains the active substances potassium citrate and potassium hydrogen carbonate.

How is Sibnayal used?

Sibnayal is available as prolonged-release granules to be taken by mouth, and can only be obtained with a prescription. Prolonged release means that the active substance in Sibnayal is released slowly into the body over a few hours after being taken. The starting dose depends on the age and body weight of the patient, and is gradually increased to obtain the optimal dose that provides adequate control of acid and potassium levels in the blood. Sibnayal is taken twice daily, typically twelve hours apart.For more information about using Sibnayal, see the package leaflet or contact your doctor or pharmacist.

How does Sibnayal work?

Sibnayal contains a combination of two salts, potassium citrate and potassium hydrogen carbonate. Because the combination is alkaline and contains potassium, it neutralises excess acid in the blood and restores levels of potassium, thus relieving the symptoms of the disease.

What benefits of Sibnayal have been shown in studies?

One study in 37 patients with dRTA showed that Sibnayal was effective at reducing the level of acid and normalising the level of potassium in the blood.Patients were first treated with their usual medicines for neutralising excess acid for 5 days, then switched to Sibnayal. The optimal dose of Sibnayal was reached gradually over 30 days, after which patients were given this dose for at least 5 days.The large majority (90%) of patients had a reduction in blood acid levels during treatment with Sibnayal, and this effect was generally maintained during 24 months of treatment. In addition, blood potassium levels returned to normal in 83% of patients. The corresponding figures during treatment with other medicines were 45% and 82%, respectively.

What are the risks associated with Sibnayal?

The most common side effects with Sibnayal (which may affect more than 1 in 10 people) is abdominal (belly) pain. Nausea (feeling sick) at start of treatment, stomach pain and gut pain may affect up to 1 in 10 people. For the full list of side effects of Sibnayal, see the package leaflet.Sibnayal must not be used in patients with moderately or severely impaired kidney function and in patients with hyperkalaemia (high blood potassium levels). For the full list of restrictions, see the package leaflet.

Why is Sibnayal authorised in the EU?

Sibnayal was shown to be effective at reducing the level of acid and normalising the level of potassium in dRTA patients' blood. The safety of Sibnayal was considered acceptable, and its side effects manageable and in line with other treatments for this disease. The European Medicines Agency therefore decided that Sibnayal's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sibnayal?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sibnayal have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sibnayal are continuously monitored. Side effects reported with Sibnayal are carefully evaluated and any necessary action taken to protect patients.

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Sifrol

What is Sifrol?

Sifrol is a medicine that contains the active substance pramipexole. It is available as 'immediaterelease' white tablets (round: 0.088, 0.7 and 1.1 mg; oval: 0.18 and 0.35 mg) and as 'prolongedrelease' white tablets (round: 0.26 and 0.52 mg; oval: 1.05, 1.57, 2.1, 2.62 and 3.15 mg). Immediate-release tablets release the active substance immediately, and prolonged-release tablets release it slowly over a few hours.

What is Sifrol used for?

Sifrol is used to treat the symptoms of the following diseases:• Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Sifrol can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;• moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.Sifrol is used when a specific cause for the disorder cannot be identified.The medicine can only be obtained with a prescription.

How is Sifrol used?

For Parkinson's disease, the starting dose is either one 0.088-mg immediate-release tablet three times a day or one 0.26-mg prolonged-release tablet once a day. The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated. The maximum daily dose is three 1.1-mg immediate-release tablets or one 3.15-mg prolonged-release tablet. Patients can be switched from the immediate- to the prolonged-release tablets overnight, but the dose might need to be adjusted depending on the patient's response. Sifrol must be given less often in patients who have problems with their kidneys. If treatment is stopped for any reason, the dose should be decreased gradually.For restless legs syndrome, Sifrol immediate-release tablets should be taken once a day, two to three hours before going to bed. The recommended starting dose is 0.088 mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of 0.54 mg. The patient's response and the need for further treatment should be evaluated after three months. The prolonged-release tablets are not suitable for restless legs syndrome.Sifrol tablets should be swallowed with water. The prolonged-release tablets must not be chewed, divided or crushed, and should be taken around the same time every day. For more information, see the package leaflet.

How does Sifrol work?

The active substance in Sifrol, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine). Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination. In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.The way pramipexole works in restless legs syndrome is not fully understood. The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be corrected by pramipexole.

How has Sifrol been studied?

In Parkinson's disease, Sifrol immediate-release tablets have been studied in five main studies. Four studies compared Sifrol with placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa. The main measure of effectiveness was the change in the severity of Parkinson's disease. The fifth study compared Sifrol with levodopa in 300 patients with early disease, and measured the number of patients who had movement symptoms.To support the use of the prolonged-release tablets, the company presented the results of studies showing that the immediate- and prolonged-release tablets produced the same levels of the active substance in the body. It also presented studies comparing the two tablets in early and advanced Parkinson's disease, and looking at switching patients from immediate- to prolonged-release tablets.In restless legs syndrome, Sifrol immediate-release tablets have also been studied in two main studies. The first compared Sifrol with placebo over 12 weeks in 344 patients and measured the improvement in symptoms. The second included 150 patients who took Sifrol for six months, and compared theSifroleffects of remaining on Sifrol with switching to placebo. The main measure of effectiveness was the time until symptoms got worse.

What benefit has Sifrol shown during the studies?

In the study of patients with advanced Parkinson's disease, patients taking Sifrol immediate-release tablets had larger improvements after 24 weeks of steady-dose treatment than those taking placebo. Similar results were seen in the first three studies of early Parkinson's disease, with greater improvements after four or 24 weeks. Sifrol was also more effective that levodopa at improving movement symptoms in early disease.The additional studies showed that the prolonged-release tablets were as effective as the immediaterelease tablets in treating Parkinson's disease. They also showed that patients can be safely switched from immediate- to prolonged-release tablets, although dose adjustments were needed in a small number of patients.In restless legs syndrome, Sifrol immediate-release tablets were more effective than placebo at reducing symptoms over 12 weeks, but the difference between placebo and Sifrol was greatest after four weeks before getting smaller. The results of the second study were insufficient to prove the longterm effectiveness of Sifrol.

What is the risk associated with Sifrol?

The most common side effect with Sifrol (seen in more than 1 patient in 10) is nausea (feeling sick). In patients with Parkinson's disease, the following side effects are also seen in more than 1 patient in 10: dizziness, dyskinesia (difficulty controlling movement) and somnolence (sleepiness). For the full list of all side effects reported with Sifrol, see the package leaflet.Sifrol should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.

Why has Sifrol been approved?

The CHMP decided that Sifrol's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Signifor

What is Signifor and what is it used for?

Signifor is a medicine for treating adults with Cushing's disease (a condition caused by too much of a hormone called cortisol) and acromegaly (excessive growth, particularly of bones in the hands, feet and face caused by too much growth hormone).Signifor is used for these conditions when surgery has failed or is not possible and, in the case of acromegaly, when the condition is also not adequately controlled with other medicines similar to Signifor known as 'somatostatin analogues'.Because the numbers of patients with these diseases are low, the diseases are considered 'rare', and Signifor was designated an 'orphan medicine' (a medicine used in rare diseases).It contains the active substance pasireotide.

How is Signifor used?

Signifor is available as a solution for injection under the skin and as a powder and liquid used for injection into the muscle.In patients with Cushing's disease, Signifor is given as an injection either under the skin (preferably at the top of the thigh and the belly) twice a day or into the buttock muscle every 4 weeks. After 2 to 4months, the patient's response to treatment should be evaluated, and the dose adjusted as appropriate or treatment stopped if no benefit is seen. If side effects develop the dose may need to be temporarily reduced.For acromegaly, Signifor is given as an injection into the buttock muscle every 4 weeks. The dose may need to be adjusted according to response, or if side effects develop.Patients can inject themselves Signifor under the skin after they have been trained. The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Signifor work?

The active substance in Signifor, pasireotide is a somatostatin analogue. This means that it works in the same way as the natural hormone, somatostatin, to block the release of growth hormone from the pituitary glands located at the base of the brain and indirectly block the release of cortisol from the adrenal gland found above the kidneys. (To reduce cortisol, pasireotide first reduces the production of another hormone ACTH, which controls cortisol production.)By reducing levels of cortisol and growth hormone, the medicine can help alleviate symptoms of Cushing's disease and acromegaly.

What benefits of Signifor have been shown in studies?

Cushing's diseaseSignifor is effective at normalising cortisol levels in some patients with Cushing's disease. In a main study in 165 adult patients who were given the injection under the skin, 15% of patients receiving 0.6 mg Signifor and 26% of patients receiving 0.9 mg Signifor had normal urine cortisol levels within 6 months. 34% of patients receiving 0.6 mg Signifor and 41% of patients receiving 0.9 mg Signifor partially responded to treatment, with their urine cortisol levels halved within 6 months.In a second study in 150 adult patients which used the muscle injection, around 41% of patients responded to treatment within 7 months.AcromegalySignifor is effective in reducing levels of growth hormone and IGF-1 (another hormone that is elevated in acromegaly patients). In a main study in 358 previously untreated adults, 31% of patients receiving Signifor had their growth hormone and IGF-1 levels reduced to pre-defined low levels after 1 year, compared with 19% of patients receiving octreotide, another somatostatin analogue. Pre-defined levels were less than 2.5 micrograms/liter for growth hormone or within normal limits for IGF-1.In the second study in 198 patients whose disease had not been adequately controlled with surgery or other medical treatment, 15% of patients receiving Signifor 40 mg and 20% of patients receiving Signifor 60 mg achieved pre-defined reductions in hormone levels after 24 weeks, compared with none of the 68 patients given the somatostatin analogues octreotide or lanreotide.Continuation of both studies confirmed the long-term benefit of Signifor in patients with acromegaly.

What are the risks associated with Signifor?

The most common side effects with Signifor (seen in more than 1 patient in 10) are hyperglycaemia(high blood sugar levels), diabetes, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick),cholelithiasis (gallstones), injection site reactions, and tiredness. For the full list of all side effects reported with Signifor, see the package leaflet.Signifor must not be used in patients with severe liver problems. For the full list of restrictions with Signifor, see the package leaflet.

Why is Signifor approved?

Signifor is effective at reducing elevated cortisol levels patients with Cushing's disease. Although the number of patients whose cortisol levels returns to normal is small, Signifor is expected tp help patients whose surgical treatments have failed or who cannot have surgery. Those patients who do not experience clinical benefit can stop treatment.Signifor is also effective in reducing levels of growth hormone in patients with acromegaly. Although its side effects are similar to those of other somatostatin analogues, high blood sugar occurred more frequently and was more severe with Signifor. For this reason, Signifor should be used for acromegaly only when the condition is not controlled by other medicines of its class.The European Medicines Agency concluded that the benefits of Signifor are greater than its risk and recommended that it approved in the EU.

What measures are being taken to ensure the safe and effective use of Signifor?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Signifor have been included in the summary of product characteristics and the package leaflet.

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Siklos

What is Siklos?

Siklos is a medicine that contains the active substance hydroxycarbamide. It is available as tablets (100 and 1,000 mg). The 1,000 mg tablet has special score lines so that it can be easily divided into four equal parts.

What is Siklos used for?

Siklos is used in adults, adolescents and children over two years of age who have sickle cell syndrome, a genetic disease where the red blood cells become rigid and sticky, and change from being discshaped to being crescent-shaped (like a sickle). It is used to prevent recurrent, painful vaso-occlusive crises that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to an organ. They can include acute chest syndrome, a life-threatening condition when the patient has sudden chest pain, fever, hard breathing or signs of fluid in the lungs on an X ray.Because the number of patients with sickle cell syndrome is low, the disease is considered 'rare', and Siklos was designated an 'orphan medicine' (a medicine used in rare diseases) on 9 July 2003.The medicine can only be obtained with a prescription.

How is Siklos used?

Treatment with Siklos should be started by a doctor who has experience in the management of sickle cell syndrome.Siklos is taken once a day, preferably in the morning before breakfast. The starting dose is usually 15 mg per kilogram body weight, using the most appropriate tablet strengths (100 or 1,000 mg) to make up the dose, breaking up the 1,000-mg tablet in quarters (250 mg) if needed. The dose is adjusted according to the response to treatment, with the usual dose being between 15 and 30 mg per kilogram body weight per day. Doses of up to 35 mg per kilogram body weight per day can be used in exceptional cases, as long as the patient's blood is monitored for side effects. Patients who do not respond to this dose or who have side effects may need to stop or suspend treatment. The dose of Siklos should be reduced in patients who have mild or moderate problems with their kidneys. For more information, see the package leaflet.

How does Siklos work?

The active substance in Siklos, hydroxycarbamide, blocks the growth and reproduction of some cells, such as blood cells. Although the precise way that it works in this disease is not understood, hydroxycarbamide can reduce the numbers of cells that are circulating in the blood, as well as prevent red blood cells changing shape in patients with sickle cell syndrome. This reduces the risk of blood vessels becoming blocked.Hydroxycarbamide, which used to be known as hydroxyurea, has been available in the European Union (EU) for several decades for use in other illnesses, including some types of cancer.

How has Siklos been studied?

Because hydroxycarbamide is a well-known substance that is already used in other medicines, the company used data from the scientific literature to support the use of Siklos in adults and children with sickle cell syndrome. In particular, it presented evidence on the effectiveness of Siklos from 11 published studies involving 378 children and from three national registries of information on 155 children with sickle cell syndrome who were treated with Siklos for up to seven years. It also presented evidence from one study in 299 adults, in which the effects of Siklos were compared with those of placebo (a dummy treatment), as well as the results of other studies involving 430 adults and one national registry of information on 123 adults treated with Siklos. The studies compared the number of vaso-occlusive crises before and after treatment with Siklos, as defined by any painful episode involving the arms, legs, abdomen, back or chest.

What benefit has Siklos shown during the studies?

Patients had fewer vaso-occlusive crises when treated with Siklos than before treatment, with the frequency falling by between 66% and 80% in children and adults. The number of cases of acute chest syndrome also fell by 25 to 33%. There were also fewer admissions into hospital, and fewer days spent in hospital. The effects were sustained for up to seven years. In the study comparing Siklos with placebo in adults, there were fewer vaso-occlusive crises in the patients taking Siklos (2.5 crises per year) than in those taking placebo (4.5 crises per year).

What is the risk associated with Siklos?

The most common side effect with Siklos (seen in more than one patient in 10) is bone marrow suppression, causing neutropenia (low levels of neutrophils, a type of white blood cell), reticulocytopenia (low levels of reticulocytes, a type of immature red blood cell) and macrocytosis (enlargement of red blood cells). Patients taking Siklos should have blood tests before and regularly during treatment, to check their blood cell counts and also to monitor their kidneys and liver. Blood cell counts normally return to normal within two weeks of stopping Siklos treatment. In men treated withSiklosSiklos, reversible oligospermia or azoospermia (reduced or absent production of healthy sperm) is also very commonly seen. For the full list of all side effects reported with Siklos, see the package leaflet.Siklos must not be used in people who have severe problems with their kidneys or liver, or who have dangerously low blood cell counts. Breast-feeding must be stopped while taking Siklos. For the full list of restrictions, see the package leaflet.

Why has Siklos been approved?

The CHMP decided that Siklos's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Siklos?

A risk management plan has been developed to ensure that Siklos is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Siklos, including the appropriate precautions to be followed by healthcare professionals and patients. The company that makes Siklos will also provide information packs for doctors and for patients describing the safety information on the medicine.

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Silapo

What is Silapo and what is it used for?

Silapo is a medicine used for the following:• to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, decreasing ability of the kidneys to work properly) or other kidney problems;• to treat anaemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions;• to increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery;• to reduce the need for blood transfusions in adults with moderate anaemia who are about to have major orthopaedic (bone) surgery, such as hip surgery. It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;• to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective). Silapo is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.Silapo contains the active substance epoetin zeta and is a 'biosimilar' medicine. This means that Silapo is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Silapo is Eprex/Erypo, which contains epoetin alfa. For more information on biosimilar medicines, see here.

How is Silapo used?

Silapo can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Silapo is approved for. The iron levels of all patients should be checked and iron supplements given if necessary.Silapo is available in pre-filled syringes and is injected either into a vein or under the skin, depending on the condition for which the patient is being treated. The injection under the skin may be given by the patient or a carer if they have been trained. The dose, how often it is given and how long it is usedfor also depend on why Silapo is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.For patients with kidney failure, myelodysplastic syndromes or who are receiving chemotherapy, haemoglobin levels should remain within the recommended range. Haemoglobin is the protein in red blood cells that carries oxygen around the body. For these patients, the lowest dose that controls the symptoms well enough should be used.For more information about using Silapo, see the package leaflet or contact your doctor or pharmacist.

How does Silapo work?

The active substance in Silapo, epoetin zeta, is a copy of a hormone called erythropoietin, and works in the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow. Erythropoietin is produced by the kidneys. In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding well enough to natural erythropoietin. In these cases, epoetin zeta is used to increase red blood cell counts. Epoetin zeta is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.

What benefits of Silapo have been shown in studies?

Laboratory studies comparing Silapo with Eprex/Erypo have shown that the active substance in Silapo is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity. Studies have also shown that giving Silapo produces similar levels of the active substance in the body to giving Eprex/Erypo.Silapo, injected into a vein, was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a procedure for removing waste products from the blood). The first study compared the effects of Silapo with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks. During the last 4 weeks of the study haemoglobin levels were around 11.6 g/dl, having risen from around 8.0 g/dl before treatment. The second study compared the effects of Silapo with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients. All of the patients in the second study had received treatment with Eprex/Erypo for at least 3 months before they were either switched to Silapo or remained on Eprex/Erypo for 12 weeks. After that, the two groups switched to receiving the other medicine for a further 12 weeks. Haemoglobin levels were maintained at around 11.4 g/dl in both groups.The company also presented the results of two studies showing that Silapo injected under the skin is as effective as other epoetin medicines: one study involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.Because Silapo is a biosimilar medicine, the studies on effectiveness and safety of epoetin carried out with Eprex/Erypo do not all need to be repeated for Silapo.

What are the risks associated with Silapo?

The most common side effects with Silapo (which may affect more than 1 in 100 people) are headache and increased blood pressure. For the full list of side effects of Silapo, see the package leaflet.Silapo must not be used in the following groups:• patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) after treatment with any epoetin medicine;• patients with hypertension (high blood pressure) that is not controlled;• patients who cannot receive medicines to prevent blood clots;• patients about to have surgery, including major orthopaedic surgery, and who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.

Why is Silapo authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Silapo has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way. In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy. All these data were considered sufficient to conclude that Silapo will behave in the same way as Eprex/Erypo in terms of effectiveness and safety in its authorised uses. Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Silapo outweighs the identified risk and it can be authorised.

What measures are being taken to ensure the safe and effective use of Silapo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silapo have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Silapo are continuously monitored. Side effects reported with Silapo are carefully evaluated and any necessary action taken to protect patients.

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Sildenafil ratiopahrm

What is sildenafil?

Sildenafil ratiopharm is a medicine that contains the active substance sildenafil. It is available as tablets (25, 50 and 100 mg).Sildenafil ratiopharm is a 'generic medicine'. This means that Sildenafil ratiopharm is similar to a 'reference medicine' already authorised in the European Union (EU) called Viagra. For more information on generic medicines, see the question-and-answer document here.

What is sildenafil used for?

Sildenafil ratiopharm is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a sufficiently hard penis (erection) for satisfactory sexual activity. For Sildenafil ratiopharm to be effective, sexual stimulation is required.The medicine can only be obtained with a prescription.

How is sildenafil used?

The recommended dose of Sildenafil ratiopharm is 50 mg taken as needed about one hour before sexual activity. If Sildenafil ratiopharm is taken with food, the onset of activity may be delayed compared with taking Sildenafil ratiopharm without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with reducedliver function or severely reduced kidney function should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.

How does sildenafil work?

The active ingredient in Sildenafil ratiopharm, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Sildenafil ratiopharm restores erectile function. Sexual stimulation is still needed to produce an erection.

How has sildenafil been studied?

Because Sildenafil ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of sildenafil?

Because Sildenafil ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has sildenafil been approved?

The CHMP concluded that, in accordance with EU requirements, Sildenafil ratiopharm has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Sildenafil ratiopharm be given marketing authorisation.

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Sildenafil Actavis

What is Sildenafil Actavis?

Sildenafil Actavis is a medicine that contains the active substance sildenafil. It is available as tablets (25, 50 and 100 mg).Sildenafil Actavis is a 'generic medicine'. This means that Sildenafil Actavis is similar to a 'reference medicine' already authorised in the European Union (EU) called Viagra. For more information on generic medicines, see the question-and-answer document here.

What is Sildenafil Actavis used for?

Sildenafil Actavis is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Sildenafil Actavis to be effective, sexual stimulation is required.The medicine can only be obtained with a prescription.

How is Sildenafil Actavis used?

The recommended dose of Sildenafil Actavis is 50 mg taken as needed about one hour before sexual activity. If Sildenafil Actavis is taken with food, the onset of activity may be delayed compared with taking Sildenafil Actavis without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with liver problems orsevere kidney problems should start treatment with the 25 mg dose. The maximum recommended dosing frequency is one tablet per day.

How does Sildenafil Actavis work?

The active ingredient in Sildenafil Actavis, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Sildenafil Actavis restores erectile function. Sexual stimulation is still needed to produce an erection.

How has Sildenafil Actavis been studied?

Because Sildenafil Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Sildenafil Actavis?

Because Sildenafil Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Sildenafil Actavis been approved?

The CHMP concluded that, in accordance with EU requirements, Sildenafil Actavis has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Sildenafil Actavis be given marketing authorisation.

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Sildenafil Teva

What is Sildenafil Teva?

Sildenafil Teva is a medicine that contains the active substance sildenafil. It is available as tablets (25, 50 and 100 mg).Sildenafil Teva is a 'generic medicine'. This means that Sildenafil Teva is similar to a 'reference medicine' already authorised in the European Union (EU) called Viagra. For more information on generic medicines, see the question-and-answer document here.

What is Sildenafil Teva used for?

Sildenafil Teva is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Sildenafil Teva to be effective, sexual stimulation is required.The medicine can only be obtained with a prescription.

How is Sildenafil Teva used?

The recommended dose of Sildenafil Teva is 50 mg taken as needed about one hour before sexual activity. If Sildenafil Teva is taken with food, the onset of activity may be delayed compared with taking Sildenafil Teva without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with liver problems or severekidney problems should start treatment with the 25 mg dose. The maximum recommended dosing frequency is one tablet per day.

How does Sildenafil Teva work?

The active ingredient in Sildenafil Teva, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Sildenafil Teva restores erectile function.Sexual stimulation is still needed to produce an erection.

How has Sildenafil Teva been studied?

Because Sildenafil Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Sildenafil Teva?

Because Sildenafil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Sildenafil Teva been approved?

The CHMP concluded that, in accordance with EU requirements, Sildenafil Teva has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Sildenafil Teva be given marketing authorisation.

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Silodosin Recordati

What is Silodosin Recordati and what is it used for?

Silodosin Recordati is a medicine used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults. The prostate gland is an organ found at the base of the bladder in men. When enlarged, it can cause problems with the flow of urine.This medicine is identical to Urorec, which has been authorised in the EU since 29 January 2010.

How is Silodosin Recordati used?

Silodosin Recordati can only be obtained with a prescription and is available as capsules (4 and 8 mg). The recommended dose is one 8 mg capsule once a day. For men with moderate kidney problems, the starting dose should be 4 mg once a day. This may be increased to 8 mg once a day after a week. Silodosin Recordati is not recommended for patients with severe kidney problems.The capsules should be taken with food, preferably at the same time every day. For more information about using Silodosin Recordati, see the package leaflet or contact your doctor or pharmacist.

How does Silodosin Recordati work?

The active substance in Silodosin Recordati, silodosin, is an alpha-adrenoreceptor antagonist. It works by blocking receptors (targets) called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body). When these receptors are activated, they cause the muscles controlling the flow of urine to contract. By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.

What benefits of Silodosin Recordati have been shown in studies?

Three main studies in over 1,800 men showed that Silodosin Recordati was effective at reducing symptoms of BPH, such as problems with urinating.The symptoms were measured using the international prostate symptom score (IPSS). In two of the studies the IPSS was around 21 points at the start of the study. After 12 weeks, the IPSS fell by 6.4 points in the men who took Silodosin Recordati compared with 3.5 points in the men who took placebo(a dummy treatment). In the third study, the IPSS was around 19 points before treatment and fell by 7 points with Silodosin Recordati compared with 6.7 points in men who took tamsulosin (another medicine used for BPH) and 4.7 points with placebo.

What are the risks associated with Silodosin Recordati?

The most common side effect with Silodosin Recordati (which may affect more than 1 in 10 people) is a reduction in the amount of semen released during ejaculation. Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery. IFIS is a condition that makes the iris floppy. For the full list of side effects and restrictions of Silodosin Recordati, see the package leaflet.

Why is Silodosin Recordati authorised in the EU?

Silodosin Recordati is effective at reducing problems with urinating in men with BPH and its side effects are comparable to those seen with other medicines of the same class. The European Medicines Agency therefore decided that Silodosin Recordati's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Silodosin Recordati?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silodosin Recordati have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Silodosin Recordati are continuously monitored. Side effects reported with Silodosin Recordati are carefully evaluated and any necessary action taken to protect patients.

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Silodyx

What is Silodyx?

Silodyx is a medicine that contains the active substance silodosin. It is available as capsules (4 and 8 mg).

What is Silodyx used for?

Silodyx is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults. The prostate gland is an organ found at the base of the bladder in men. When enlarged, it can cause problems with the flow of urine.The medicine can only be obtained with a prescription.

How is Silodyx used?

The recommended dose is one 8 mg capsule once a day. For men with moderate kidney problems, the starting dose should be 4 mg once a day. This may be increased to 8 mg once a day after a week. Silodyx is not recommended for patients with severe kidney problems.The capsules should be taken with food, preferably at the same time every day. They should be swallowed whole, preferably with a glass of water.

How does Silodyx work?

The active substance in Silodyx, silodosin, is an alpha adrenoreceptor antagonist. It works by blocking receptors called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body). When these receptors are activated, they cause the muscles controlling the flow of urine to contract. By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.

How has Silodyx been studied?

The effects of Silodyx were first tested in experimental models before being studied in humans. Silodyx has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH. One of these studies also compared Silodyx with tamsulosin (another medicine used for BPH).The main measure of effectiveness in all three studies was the improvement of the patients' international prostate symptom score (IPSS) after 12 weeks of treatment. IPSS is a rating of the patient's symptoms such as the inability to empty the bladder, and the urge to urinate repeatedly or to strain while urinating. The patients rated the severity of their symptoms themselves.

What benefit has Silodyx shown during the studies?

Silodyx was more effective than placebo and as effective as tamsulosin at reducing symptoms of BPH. In the two studies where Silodyx was compared only with placebo, the IPSS was around 21 points at the start of the study. After 12 weeks, it had fallen by around 6.4 points in the men who took Silodyx, and by around 3.5 points in the men who took placebo. In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Silodyx after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.

What is the risk associated with Silodyx?

The most common side effect with Silodyx (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation. Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery. IFIS is a condition that makes the iris floppy. For the full list of all side effects and restrictions with Silodyx, see the package leaflet.

Why has Silodyx been approved?

The CHMP decided that Silodyx's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Silodyx?

A risk management plan has been developed to ensure that Silodyx is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Silodyx, including the appropriate precautions to be followed by healthcare professionals and patients.In addition, the company that makes Silodyx will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.

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Simbrinza

What is Simbrinza and what is it used for?

Simbrinza is an eye drop solution that contains two active substances: brinzolamide and brimonidine tartrate. Simbrinza is used to reduce intra-ocular pressure (pressure inside the eye) in adults with ocular hypertension (high intra-ocular pressure) or in those with an eye condition known as open-angle glaucoma.Simbrinza is used when treatment with other medicines containing only one active substance have been tried but has not reduced the intra-ocular pressure sufficiently.

How is Simbrinza used?

Simbrinza is given as one drop into the affected eye(s) twice a day. If other eye drops are also being used to lower eye pressure, they should be given at least 5 minutes apart.Simbrinza can only be obtained by prescription. For further information, see the package leaflet.

How does Simbrinza work?

Open-angle glaucoma (a condition where the aqueous humour, the watery fluid inside the eyeball, cannot drain away properly) and other causes of high pressure in the eye increase the risk of damage to the retina and the optic nerve (the nerve that sends signals from the eye to the brain). This can result in serious vision loss and even blindness.The active substances in Simbrinza, brinzolamide and brimonidine tartrate, help to reduce intra-ocular pressure by reducing the production of aqueous humour. Brinzolamide works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate needed for the production of the aqueous humour, while brimonidine tartrate blocks another enzyme known as adenylate cyclase, which is also involved in the production of the aqueous humour. Brimonidine also increases the drainage of aqueous humour from the front of the eye.Both medicines have been used separately to reduce eye pressure for several years in the EU and their combination reduces the pressure inside the eye more effectively than either medicine alone.

What benefits of Simbrinza have been shown in studies?

Simbrinza has been shown to be more effective in reducing eye pressure than either brinzolamide or brimonidine tartrate used alone. One main study involved 560 patients with ocular hypertension or open-angle glaucoma, whose average intra-ocular pressure before treatment, measured in units called mmHg, was 26 mmHg. The reduction in intra-ocular pressure after 3 months was greater in patients using Simbrinza (an average fall of 7.9 mmHg) than in those using either brinzolamide or brimonidine tartrate (6.5 and 6.4 mmHg, respectively).A second main study involving 890 patients compared Simbrinza with a combination treatment of brinzolamide and brimonidine tartrate given as separate drops. Simbrinza was shown to be as effective as the combination treatment. The average reduction in intra-ocular pressure with Simbrinza after 3 months was 8.5 mmHg compared with 8.3 mmHg with the combination.

What are the risks associated with Simbrinza?

The most common side effects in studies with Simbrinza were ocular hyperaemia (red eye) and allergic reactions in the eye, which occurred in about 6 to 7% of patients, and dysgeusia (taste disturbances) in about 3% of patients. For the full list of all side effects reported with Simbrinza, see the package leaflet.Simbrinza must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, or to sulphonamides (a class of antibiotics). It must also not be used in patients receiving certain types of antidepressants, patients with severely reduced kidney function, or in patients with hyperchloraemic acidosis (excess acid in the blood caused by too much chloride).Simbrinza must not be used in neonates or children under the age of two years and is not recommended in older children.

Why is Simbrinza approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Simbrinza was shown to be more effective than either active substance used alone and at least as effective as the combination of the active substances given as separate eye drops. Having the two active substances in one eye drop will improve convenience and adherence to treatment for patients who are not adequately controlled with either brimonidine or brinzolamide alone. It will also benefit those patients who need a combination treatment and for whom previously authorised combinations containing the medicine timolol are not suitable.As regards safety, the side effects reported with Simbrinza were what would be expected with the individual active substances and raised no major concerns. The CHMP therefore concluded that Simbrinza's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Simbrinza?

A risk management plan has been developed to ensure that Simbrinza is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Simbrinza, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.

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Simponi

What is Simponi and what is it used for?

Simponi is an anti-inflammatory medicine. It is used to treat the following diseases:• active rheumatoid arthritis (a disease causing inflammation of the joints). Simponi is used in combination with methotrexate (a medicine that acts on the immune system). It can be used in adults who have not responded adequately to other treatments including methotrexate whose disease is moderate to severe, and in patients who have not previously been treated with methotrexate whose disease is severe and progressive;• active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints). Simponi is used in adults who have not responded adequately to other treatments. It can be used alone or in combination with methotrexate;• axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including:- adults with severe active ankylosing spondylitis who have not responded adequately to other treatments;- adults with severe non-radiographic axial spondyloarthritis (when there are objective signs of inflammation but no abnormalities seen on x-ray) who have not responded adequately or are intolerant to anti-inflammatory medicines called non-steroidal anti-• moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut). Simponi is used in adults who have not responded adequately to, or cannot use, conventional treatment;• polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints). Simponi is used in combination with methotrexate. It is used in children from 2 years of age who have not responded adequately to treatment with methotrexate.Simponi contains the active substance golimumab.

How is Simponi used?

Simponi is available as pre-filled pens and syringes containing a solution for injection under the skin. The recommended dose depends on the disease Simponi is used to treat and the response of the patient.Simponi can only be obtained with a prescription and treatment must be initiated and supervised by a qualified doctor who has experience in the diagnosis and treatment of the diseases that Simponi is used to treat. After training, patients may inject themselves with Simponi if their doctor agrees.For more information about using Simponi, see the package leaflet or contact your doctor or pharmacist.

How does Simponi work?

The active substance in Simponi, golimumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Golimumab has been designed to attach to and block a substance in the body called tumour necrosis factor alpha (TNF-a). This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Simponi is used to treat. By blocking TNF-a, golimumab reduces the inflammation and other symptoms of these diseases.

What benefits of Simponi have been shown in studies?

Simponi has been shown to be effective at reducing the number and severity of symptoms in patients with the conditions for which it is authorised.Rheumatoid arthritisFor rheumatoid arthritis, Simponi was compared with placebo (a dummy treatment) in three studies involving 1,542 patients with moderate to severe rheumatoid arthritis, including patients who had not received or responded adequately to other treatments.In the first study, in which patients were also given methotrexate, after 14 weeks, 55% patients who received Simponi (49 out of 89) achieved 20% reductions compared with 33% (44 out of 133) of patients who received placebo. This study also showed that patients who received Simponi had greater improvements in carrying out everyday tasks (such as dressing, eating and walking) after 24 weeks. In the second study, after 14 weeks, 35% of patients who received Simponi alone (54 out of 153) achieved 20% reductions in the number and severity of symptoms compared with 18% of patients who received placebo (28 out of 155). In the third study, in patients who had not been previously treated with either methotrexate or another anti-TNF-a, after 24 weeks, 40% of patients (64 out of 159) who received Simponi with methotrexate achieved 50% reductions compared with 29% of patients (47 out of 160) who received placebo and methotrexate. Data from X-rays taken before and after two years of treatment showed less joint damage in patients receiving Simponi than in those receiving placebo.Psoriatic arthritisFor psoriatic arthritis, Simponi was compared with placebo over 24 weeks in one main study involving405 patients who had not responded adequately to other treatments. Of the patients who received Simponi, 51% (74 out of 146) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 9% of patients who were given placebo (10 out of 113).Ankylosing spondylitisFor ankylosing spondylitis, Simponi was compared with placebo over 24 weeks in one main study involving 356 patients who had not responded adequately to other treatments. Of the patients who received Simponi, 59% (82 out of 138) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 22% of patients who were given placebo (17 out of 78).Axial spondyloarthritisFor non-radiographic axial spondyloarthritis, Simponi was compared with placebo over 16 weeks in one main study involving 198 patients who had the disease without evidence of ankylosing spondylitis but with signs of inflammation and who had not responded adequately to treatment with NSAIDs. Of the patients who received Simponi, 71% (69 out of 97) had 20% reductions in the number and severity of symptoms after 16 weeks, compared with 40% of patients who were given placebo (40 out of 100).Ulcerative colitisFor ulcerative colitis, Simponi was compared with placebo in two main studies in patients who had not responded to or could not use other treatments. The first study, involving 1,065 patients, compared different doses of Simponi with placebo as induction treatment. The second study, involving 1,228 patients, compared Simponi 50 or 100 mg with placebo as maintenance treatment. The main measure of effectiveness was the number of patients who responded to treatment, based on the number and severity of symptoms. This was assessed after 6 weeks in the first study and after 54 weeks in the second study. In the first study, around 51% of patients receiving induction treatment with Simponi (starting at 200 mg) responded to treatment after 6 weeks, compared with around 30% of patients given placebo. In the second study, around 50% of patients receiving maintenance treatment with Simponi 100 mg and around 47% of those given Simponi 50 mg responded to treatment after 54 weeks, compared with around 31% of patients given placebo.Polyarticular juvenile idiopathic arthritisFor polyarticular juvenile idiopathic arthritis, 173 patients between 2 and 18 years old who had not responded adequately to treatment with methotrexate were treated for 12 weeks with Simponi and methotrexate. Of these patients, 87% of (151 out of 173) had 30% reduction in the number and severity of symptoms after 16 weeks. Treatment with Simponi and methotrexate was not compared with placebo or any other treatment.

What are the risks associated with Simponi?

The most common side effects with Simponi are upper respiratory tract infections such as infections of the nose, throat or voice box. The most serious side effects include serious infections, such as sepsis (blood infection), pneumonia (lung infection), tuberculosis and infections due to fungi or yeasts, demyelinating disorders (disorders suggesting damage to the protective sheath around nerves, such as changes to vision and weak arms or legs), re-activation of hepatitis B (a disease of the liver due to infection with the hepatitis B virus), congestive heart failure (a heart disease), lupus-like syndrome, blood reactions, severe allergic reactions, vasculitis (inflammation of the blood vessels), and lymphoma and leukaemia (types of cancer of the white blood cells). For the full list of side effects reported with Simponi, see the package leaflet.Simponi must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body). Due to an increasedrisk of infection, patients taking Simponi must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment. For the full list of restrictions with Simponi, see the package leaflet.

Why is Simponi authorised in the EU?

The European Medicines Agency decided that Simponi's benefits are greater than its risks and that it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Simponi?

Patients treated with Simponi must be given a reminder card that summarises the safety information about the medicine and when to seek medical advice. Patients should show this card when seeing a healthcare professional, so that they are aware that the patient is using Simponi.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Simponi have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Simponi is continuously monitored. Side effects reported with Simponi are carefully evaluated and any necessary action taken to protect patients.

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Simulect

What is Simulect?

Simulect is a powder and solvent that are made up into a solution for injection or infusion (drip into a vein). It contains the active substance basiliximab.

What is Simulect used for?

Simulect is used in adults and children aged over one year, to prevent the body from rejecting a newly transplanted kidney. Simulect is used in combination with other medicines used to prevent organ rejection, such as ciclosporin, corticosteroids, azathioprine and mycophenolate mofetil. The medicine can only be obtained with a prescription.

How is Simulect used?

Simulect should only be prescribed and given by a doctor who has experience in the use of immunosuppressive treatment following an organ transplant. It should be given under qualified medical supervision. Simulect should not be given unless it is absolutely certain that the patient will receive the transplant and other medicines to prevent rejection.Simulect is given as two injections. The first injection should be given a maximum of two hours before transplantation surgery, and the second four days after the transplant, unless the patient has had a severe hypersensitivity (allergic) reaction or has complications after the operation, such as loss of the new kidney. In adults and children weighing more than 35 kg, the recommended total dose is 40 mg, given as two 20 mg doses. In children weighing less than 35 kg, it is 20 mg, given as two 10 mg doses. Simulect is given into a vein, either as a 'bolus' injection (given all at once) or as an infusion over 20 to 30 minutes.

How does Simulect work?

The active substance in Simulect, basiliximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body. Basiliximab has been designed to target an antigen called CD25, which is present on the surface of T-lymphocytes (a type of white blood cell that is involved in the rejection of organ transplants).CD25 is a receptor for the messenger interleukin-2, which stimulates the T-lymphocytes to divide. By binding to CD25, basiliximab blocks the activity of interleukin-2, reducing the rate at which thelymphocytes multiply. This reduces the number of activated T-lymphocytes, lowering the risk of the transplant being rejected.

How has Simulect been studied?

Simulect has been assessed in three main studies involving a total of 1,067 adults who were having a kidney transplant. All three studies compared the effectiveness of Simulect with that of placebo (a dummy treatment). In the first two studies, most of the 722 patients were also taking ciclosporin and corticosteroids ('dual therapy'), with some patients also taking azathioprine or mycophenolate mofetil. In the third study, all 345 adults were taking ciclosporin, steroids and azathioprine ('triple therapy'). The main measure of effectiveness was the number of treatment failures (death, loss of the new kidney or signs of rejection) over the first year after the transplant.Two additional studies looked at how Simulect is handled in the body when it is given to children aged over one year or to adolescents.

What benefit has Simulect shown during the studies?

Simulect was more effective than placebo. Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359). Similar results were seen after a year. In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).The studies in children and adolescents showed that the lower dose of Simulect was appropriate for children, and that adolescents could use the adult dose.

What is the risk associated with Simulect?

In the studies, side effects were similar in patients taking Simulect and those receiving placebo, in combination with other medicines. In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds). In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation. For the full list of all side effects reported with Simulect, see the Package Leaflet.Simulect should not be used in people who may be hypersensitive to basiliximab or any of the other ingredients. Simulect must not be used during pregnancy or breast-feeding.

Why has Simulect been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients. The Committee recommended that Simulect be given marketing authorisation.

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Sirturo

What is Sirturo and what is it used for?

Sirturo is a tuberculosis medicine that contains the active substance bedaquiline. Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis.Sirturo is used in combination with other tuberculosis medicines in adults and children (aged at least 5 years and weighing at least 15 kg) with tuberculosis in the lung that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines). It is given when other combinations cannot be used, either because the disease is resistant to them or because of their side effects.Tuberculosis is rare in the EU, and Sirturo was designated an 'orphan medicine' (a medicine used in rare diseases) on 26 August 2005. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu305314.

How is Sirturo used?

Sirturo can only be obtained with a prescription. Treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis. In addition, it is recommended that a healthcare professional watches the patients as they take the medicine.The medicine is available as tablets. The recommended dose in adults is 400 mg once a day for the first 2 weeks and then 200 mg 3 times a week for the next 22 weeks. In children the dose depends on the child's weight. The tablets should be taken with food. For more information about using Sirturo, see the package leaflet or contact your doctor or pharmacist.

How does Sirturo work?

The active substance in Sirturo, bedaquiline, blocks an enzyme inside the M. tuberculosis bacteria called ATP synthase, which the bacteria need to generate energy. Without the ability to generate energy, the bacteria die and the patient's condition starts to improve.

What benefits of Sirturo have been shown in studies?

In a main study in patients with multi-drug resistant tuberculosis affecting the lung, Sirturo was compared with placebo (a dummy treatment) when added to combination treatment with other standard tuberculosis medicines. The study showed that after 24 weeks, 79% of the patients given Sirturo (52 out of 66 patients) tested negative for the bacteria in the sputum (phlegm) compared with 58% of patients given placebo (38 out of 66 patients). The average time it took to clear the bacteria from the sputum was also shorter for patients in the Sirturo group than for those in the placebo group (83 days versus 125 days).The way Sirturo is handled in the body in children has been shown to be the same as in adults; it is therefore also expected to be effective at treating tuberculosis in children.

What are the risks associated with Sirturo?

The most common side effects with Sirturo in adults (which may affect more than 1 in 10 people) are headache, dizziness, nausea (feeling sick), vomiting, and arthralgia (joint pain). Overall, the side effects in adolescents are similar to those in adults. Blood tests showing increased liver enzymes and other effects on the liver occur in about 1 in 3 younger children. For the full list of all side effects and restrictions, see the package leaflet.

Why is Sirturo authorised in the EU?

The main study showed that Sirturo increased the number of patients who tested negative for the tuberculosis bacteria and shortened the average time it took to clear the bacteria from the sputum. Furthermore, Sirturo was the first of a new class of medicines for which cross-resistance had not yet occurred. Cross-resistance is when bacteria resistant to one medicine are also resistant to a different medicine not used previously, which is often the case with multi-drug resistant tuberculosis.The side effects in the Sirturo group in the main study were not markedly different from those in the placebo group, though there were higher levels of liver enzymes and some reports of alterations in the heart's electrical activity (known as prolonged QT interval). Also, a higher number of deaths was reported in the Sirturo group. Although an analysis did not conclude that Sirturo caused these deaths, the company will provide more information from a long-term follow-up study to address any concerns.The European Medicines Agency concluded that Sirturo's benefits are greater than its risks and it can be authorised for use in the EU.Sirturo has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Sirturo?

Since Sirturo has been given conditional authorisation, the company that markets Sirturo will provide longer term safety data on the medicine.

What measures are being taken to ensure the safe and effective use of Sirturo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sirturo have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sirturo are continuously monitored. Side effects reported with Sirturo are carefully evaluated and any necessary action taken to protect patients.

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Sitagliptin Accord

What is Sitagliptin Accord and what is it used for?

Sitagliptin Accord is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:• on its own, in patients whose blood glucose levels are not satisfactorily controlled with diet and exercise and who cannot take metformin (a diabetes medicine);• in combination with metformin or a PPAR-gamma agonist (a type of diabetes medicine) such as a thiazolidinedione, in patients whose blood glucose levels are not satisfactorily controlled with metformin or the PPAR-gamma agonist used on its own;• in combination with a sulphonylurea (another type of diabetes medicine), in patients whose blood glucose levels are not satisfactorily controlled with a sulphonylurea used on its own and who cannot take metformin;• in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients whose blood glucose levels are not satisfactorily controlled with the two medicines;• in combination with insulin, with or without metformin, in patients whose blood glucose levels are not satisfactorily controlled with a stable dose of insulin.Sitagliptin Accord contains the active substance sitagliptin and is a 'generic medicine'. This means that Sitagliptin Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Januvia. For more information on generic medicines, see the question-and-answer document here.

How is Sitagliptin Accord used?

Sitagliptin Accord is available as tablets and can only be obtained with a prescription. The recommended dose is 100 mg once a day. The dose may be lowered in some patients with reduced kidney function. If Sitagliptin Accord is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood glucose levels).SendFor more information about using Sitagliptin Accord, see the package leaflet or contact your doctor or pharmacist.

How does Sitagliptin Accord work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Sitagliptin Accord, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of 'incretin' hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when blood glucose levels are low. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has Sitagliptin Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Januvia, and do not need to be repeated for Sitagliptin Accord.As for every medicine, the company provided data on the quality of Sitagliptin Accord. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Sitagliptin Accord?

Because Sitagliptin Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sitagliptin Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Sitagliptin Accord has been shown to have comparable quality and to be bioequivalent to Januvia. Therefore, the Agency's view was that, as for Januvia, the benefits of Sitagliptin Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sitagliptin Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sitagliptin Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sitagliptin Accord are continuously monitored. Suspected side effects reported with Sitagliptin Accord are carefully evaluated and any necessary action taken to protect patients.

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Sitagliptin Sun

What is Sitagliptin SUN and what is it used for?

Sitagliptin SUN is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:• on its own, in patients whose blood glucose levels are not satisfactorily controlled with diet and exercise and who cannot take metformin (a diabetes medicine);• in combination with metformin or a PPAR-gamma agonist (a type of diabetes medicine) such as a thiazolidinedione, in patients whose blood glucose levels are not satisfactorily controlled with metformin or the PPAR-gamma agonist used on its own;• in combination with a sulphonylurea (another diabetes medicine) in patients whose blood glucose levels are not satisfactorily controlled with a sulphonylurea used on its own and who cannot take metformin;• in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients whose blood glucose levels are not satisfactorily controlled with the two medicines;• in combination with insulin, with or without metformin, in patients whose blood glucose levels are not satisfactorily controlled with a stable dose of insulin.Sitagliptin SUN contains the active substance sitagliptin and is a 'generic medicine'. This means that Sitagliptin SUN contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Januvia. For more information on generic medicines, see the question-and-answer document here.

How is Sitagliptin SUN used?

Sitagliptin SUN is available as tablets and can only be obtained with a prescription. The recommended dose is 100 mg once a day. The dose may be lowered in some patients with reduced kidney function. If Sitagliptin SUN is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood glucose levels).For more information about using Sitagliptin SUN, see the package leaflet or contact your doctor or pharmacist.Send

How does Sitagliptin SUN work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Sitagliptin SUN, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of 'incretin' hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when blood glucose levels are low. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has Sitagliptin SUN been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Januvia, and do not need to be repeated for Sitagliptin SUN.As for every medicine, the company provided data on the quality of Sitagliptin SUN. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Sitagliptin SUN?

Because Sitagliptin SUN is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sitagliptin SUN authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Sitagliptin SUN has been shown to have comparable quality and to be bioequivalent to Januvia. Therefore, the Agency's view was that, as for Januvia, the benefits of Sitagliptin SUN outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sitagliptin SUN?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sitagliptin SUN have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sitagliptin SUN are continuously monitored. Suspected side effects reported with Sitagliptin SUN are carefully evaluated and any necessary action taken to protect patients.

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Sitagliptin/Metformin Hydrochloride Accord

What is Sitagliptin/Metformin hydrochloride Accord and what is it used for?

Sitagliptin/Metformin hydrochloride Accord is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:• in patients whose blood glucose levels are not satisfactorily controlled with metformin (a diabetes medicine) used on its own;• in patients who are already taking a combination of sitagliptin and metformin as separate tablets;• in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin (other types of diabetes medicines) in patients whose blood glucose levels are not satisfactorily controlled with either of these medicines and metformin.Sitagliptin/Metformin hydrochloride Accord contains the active substances sitagliptin and metformin hydrochloride and is a 'generic medicine'. This means that Sitagliptin/Metformin hydrochloride Accord contains the same active substances and works in the same way as a 'reference medicine' already authorised in the EU called Janumet. For more information on generic medicines, see the questionand-answer document here.

How is Sitagliptin/Metformin hydrochloride Accord used?

Sitagliptin/Metformin hydrochloride Accord is available as tablets and can only be obtained with a prescription. The medicine is taken twice a day and the dose depends on the dose of the other diabetes medicines that the patient was taking before. If Sitagliptin/Metformin hydrochloride Accord is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels). The maximum dose of sitagliptin is 100 mg a day. Sitagliptin/Metformin hydrochloride Accord should be taken with food to avoid any stomach problems caused by metformin.For more information about using Sitagliptin/Metformin hydrochloride Accord, see the package leaflet or contact your doctor or pharmacist.Send

How does Sitagliptin/Metformin hydrochloride Accord work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively. The active substances inSitagliptin/Metformin hydrochloride Accord each have a different mode of action to help correct this.Sitagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of 'incretin' hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when blood glucose levels are low. Sitagliptin also reduces the amount of glucose made by the liver by increasing insulin levels and decreasing the levels of the hormone glucagon.Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has Sitagliptin/Metformin hydrochloride Accord been studied?

Studies on the benefits and risks of the active substances in the authorised use have already been carried out with the reference medicine, Janumet, and do not need to be repeated for Sitagliptin/Metformin hydrochloride Accord.As for every medicine, the company provided data on the quality of Sitagliptin/Metformin hydrochloride Accord. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Sitagliptin/Metformin hydrochloride Accord?

Because Sitagliptin/Metformin hydrochloride Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sitagliptin/Metformin hydrochloride Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements,Sitagliptin/Metformin hydrochloride Accord has been shown to have comparable quality and to be bioequivalent to Janumet. Therefore, the Agency's view was that, as for Janumet, the benefits of Sitagliptin/Metformin hydrochloride Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sitagliptin/Metformin hydrochloride Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sitagliptin/Metformin hydrochloride Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sitagliptin/Metformin hydrochloride Accord are continuously monitored. Suspected side effects reported with Sitagliptin/Metformin hydrochloride Accord are carefully evaluated and any necessary action taken to protect patients.Sitagliptin/Metformin hydrochloride Accord (sitagliptin/metformin hydrochloride)

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Sitagliptin/Metformin Hydrochloride Mylan

What is Sitagliptin/Metformin hydrochloride Mylan and what is it used for?

Sitagliptin/Metformin hydrochloride Mylan is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:• in patients whose blood glucose levels are not satisfactorily controlled with metformin (a diabetes medicine) used on its own;• in patients who are already taking a combination of sitagliptin and metformin as separate tablets;• in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin (other types of diabetes medicines) in patients whose blood glucose levels are not satisfactorily controlled with either of these medicines and metformin.Sitagliptin/Metformin hydrochloride Mylan contains the active substances sitagliptin and metformin hydrochloride and is a 'generic medicine'. This means that Sitagliptin/Metformin hydrochloride Mylan contains the same active substances and works in the same way as a 'reference medicine' already authorised in the EU called Janumet. For more information on generic medicines, see the questionand-answer document here.

How is Sitagliptin/Metformin hydrochloride Mylan used?

Sitagliptin/Metformin hydrochloride Mylan is available as tablets and can only be obtained with a prescription. The medicine is taken twice a day and the strength of the tablet depends on the dose of the other diabetes medicines that the patient was taking before. If Sitagliptin/Metformin hydrochloride Mylan is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels). The maximum dose of sitagliptin is 100 mg a day. Sitagliptin/Metformin hydrochloride Mylan should be taken with food to avoid any stomach problems caused by metformin.For more information about using Sitagliptin/Metformin hydrochloride Mylan, see the package leaflet or contact your doctor or pharmacist.Send

How does Sitagliptin/Metformin hydrochloride Mylan work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively. The active substances in Sitagliptin/Metformin hydrochloride Mylan each have a different mode of action.Sitagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of 'incretin' hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when blood glucose levels are low. Sitagliptin also reduces the amount of glucose made by the liver by increasing insulin levels and decreasing the levels of the hormone glucagon.Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has Sitagliptin/Metformin hydrochloride Mylan been studied?

Studies on the benefits and risks of the active substances in the authorised use have already been carried out with the reference medicine, Janumet, and do not need to be repeated for Sitagliptin/Metformin hydrochloride Mylan.As for every medicine, the company provided data on the quality of Sitagliptin/Metformin hydrochloride Mylan. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Sitagliptin/Metformin hydrochloride Mylan?

Because Sitagliptin/Metformin hydrochloride Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sitagliptin/Metformin hydrochloride Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements,Sitagliptin/Metformin hydrochloride Mylan has been shown to have comparable quality and to be bioequivalent to Janumet. Therefore, the Agency's view was that, as for Janumet, the benefits of Sitagliptin/Metformin hydrochloride Mylan outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sitagliptin/Metformin hydrochloride Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sitagliptin/Metformin hydrochloride Mylan have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sitagliptin/Metformin hydrochloride Mylan are continuously monitored. Suspected side effects reported with Sitagliptin/Metformin hydrochloride Mylan are carefully evaluated and any necessary action taken to protect patients.

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Sitagliptin/Metformin Hydrochloride Sun

What is Sitagliptin/Metformin hydrochloride Sun and what is it used for?

Sitagliptin/Metformin hydrochloride Sun is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:• in patients whose blood glucose levels are not satisfactorily controlled with metformin (a diabetes medicine) used on its own;• in patients who are already taking a combination of sitagliptin and metformin as separate tablets;• in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin (other types of diabetes medicines) in patients whose blood glucose levels are not satisfactorily controlled with these individual medicines and metformin.Sitagliptin/Metformin hydrochloride Sun contains the active substances sitagliptin and metformin hydrochloride and is a 'generic medicine'. This means that Sitagliptin/Metformin hydrochloride Sun contains the same active substances and works in the same way as a 'reference medicine' already authorised in the EU called Janumet. For more information on generic medicines, see the questionand-answer document here.

How is Sitagliptin/Metformin hydrochloride Sun used?

Sitagliptin/Metformin hydrochloride Sun is available as tablets and can only be obtained with a prescription. The medicine is taken twice a day and the dose depends on the dose of the other diabetes medicines that the patient was taking before.If Sitagliptin/Metformin hydrochloride Sun is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).For more information about using Sitagliptin/Metformin hydrochloride Sun, see the package leaflet or contact your doctor or pharmacist.Send

How does Sitagliptin/Metformin hydrochloride Sun work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively. The active substances in Sitagliptin/Metformin hydrochloride Sun each have a different mode of action to help correct this.Sitagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of incretin hormones in the body which are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when blood glucose levels are low. Sitagliptin also reduces the amount of glucose made by the liver by increasing insulin levels and decreasing the levels of the hormone glucagon.Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.Together, these actions reduce blood glucose levels which helps to control type 2 diabetes.

How has Sitagliptin/Metformin hydrochloride Sun been studied?

Studies on the benefits and risks of the active substances in the authorised use have already been carried out with the reference medicine, Janumet, and do not need to be repeated for Sitagliptin/Metformin hydrochloride Sun.As for every medicine, the company provided data on the quality of Sitagliptin/Metformin hydrochloride Sun. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Sitagliptin/Metformin hydrochloride Sun?

Because Sitagliptin/Metformin hydrochloride Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sitagliptin/Metformin hydrochloride Sun authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Sitagliptin/Metformin hydrochloride Sun has been shown to have comparable quality and to be bioequivalent to Janumet. Therefore, the Agency's view was that, as for Janumet, the benefits of Sitagliptin/Metformin hydrochloride Sun outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sitagliptin/Metformin hydrochloride Sun?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sitagliptin/Metformin hydrochloride Sun have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sitagliptin/Metformin hydrochloride Sun are continuously monitored. Suspected side effects reported with Sitagliptin/Metformin hydrochloride Sun are carefully evaluated and any necessary action taken to protect patients.Sitagliptin/Metformin hydrochloride Sun (sitagliptin/metformin hydrochloride)

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Sivextro

What is Sivextro and what is it used for?

Sivextro is an antibiotic used in patients from 12 years of age to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (infection of the skin and the tissue underneath), skin abscesses (a swollen area on the skin where pus has collected) and wound infections.Before using Sivextro, doctors should consider official guidance on the appropriate use of antibiotics.Sivextro contains the active substance tedizolid.

How is Sivextro used?

Sivextro is available for infusion (drip) into a vein and as tablets to take by mouth. The recommended dose is 200 mg once a day for 6 days. Patients who are started on the infusion may be switched to the tablets when appropriate.Sivextro can only be obtained with a prescription.For more information about using Sivextro, see the package leaflet or contact your doctor or pharmacist.

How does Sivextro work?

The active substance in Sivextro, tedizolid, is a type of antibiotic called an oxazolidinone. It works by preventing certain bacteria from making proteins, thereby stopping their growth. Sivextro has been shown to work against bacteria (such as meticillin-resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work. A list of bacteria against which Sivextro is active can be found in the summary of product characteristics.

What benefits of Sivextro have been shown in studies?

Sivextro was at least as effective as linezolid (another oxazolidinone antibiotic) in two main studies involving a total of 1,333 adults with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections. These included infections caused by MRSA. Of thepatients treated with Sivextro, 85.5% were cured in the first study and 88.0% in the second study, compared with 86.0% and 87.7% respectively of patients treated with linezolid.In a study involving 120 patients aged from 12 years up to 18 years, Sivextro was at least as effective as other medicines used for treating acute bacterial infections of the skin and of skin structures. The study also found that blood levels of the medicine in these patients were similar to those in adults treated with Sivextro.

What are the risks associated with Sivextro?

The most common side effects with Sivextro (which may affect up to 1 in 10 people) are headache, nausea (feeling sick), vomiting and diarrhoea.For the full list of side effects and restrictions of Sivextro, see the package leaflet.

Why is Sivextro authorised in the EU?

The European Medicines Agency decided that Sivextro's benefits are greater than its risks and it can be authorised for use in the EU.Although the infections in the studies were not severe, the Agency considered that the results also apply to severe infections. Because of the need for new antibiotics against bacteria that have become resistant to several antibiotics, especially those that can be given by mouth, the Agency considered Sivextro a valuable treatment option for bacterial infections of the skin and of skin structures.Sivextro's pattern of side effects is comparable to that of linezolid and was considered acceptable.

What measures are being taken to ensure the safe and effective use of Sivextro?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sivextro have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sivextro are continuously monitored. Side effects reported with Sivextro are carefully evaluated and any necessary action taken to protect patients.

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Sixmo

What is Sixmo and what is it used for?

Sixmo is an implant used to treat dependence on opioid drugs such as heroin or morphine. It contains the active substance buprenorphine.Sixmo is used in adults who are already stable while taking buprenorphine under the tongue (no more than 8 mg/day), and who are also receiving medical, social and psychological support.

How is Sixmo used?

Sixmo is available as an implant to be inserted under the skin, which continuously releases buprenorphine into the body. The patient receives four implants, which are inserted under local anaesthesia in the inner side of the upper arm and kept in place for 6 months.Sixmo can only be obtained by 'special' prescription. This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal. Treatment with Sixmo must be under the supervision of a healthcare professional experienced in the management of opioid dependence. The insertion and removal of the implant must be performed by a doctor who is experienced in minor surgery and has been trained to carry out the insertion and removal procedures.For more information about using Sixmo, see the package leaflet or contact your doctor or pharmacist.

How does Sixmo work?

The active substance in Sixmo, buprenorphine, is a partial opioid agonist (which means that it acts like an opioid but less powerfully). The medicine can therefore be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.

What benefits of Sixmo have been shown in studies?

Three studies involving a total of 627 patients with opioid dependence showed that Sixmo is effective at reducing patients' intake of opioids.The first study compared Sixmo with placebo (dummy) implants in 163 patients who had not received buprenorphine before. During the first 4 months of treatment, the percentage of negative urine testsfor opioids was around 40% for patients treated with Sixmo, compared with around 28% for those treated with placebo.The second study in 287 patients who had not received buprenorphine before compared Sixmo with placebo implants and with sublingual buprenorphine (given under the tongue). During the 6 months of treatment, the percentage of negative urine tests for opioids was around 31% for Sixmo, 13% for placebo and 33% for sublingual buprenorphine.In both of these studies, the number of urine tests that were negative for opioid use decreased towards the end of the treatment period, indicating a reduction of the effect of Sixmo over time.The third study compared Sixmo with sublingual buprenorphine in 177 patients whose opioid dependence was already being managed with sublingual buprenorphine at a daily dose of up to 8 mg. After 6 months of treatment, around 96% of patients who received Sixmo responded to treatment (i.e.there was no evidence of opioid use in at least 4 out of 6 months) compared with around 88% in patients on sublingual buprenorphine.

What are the risks associated with Sixmo?

The most common side effects with Sixmo (which may affect up to 1 in 10 people) include headache, constipation and difficulty sleeping. The most common side effects related to the insertion and removal of the implant are pain, itching, bruising, bleeding, reddening of the skin and rash at the site of the implant. For the full list of side effects of Sixmo, see the package leaflet.Sixmo must not be used by patients with severe respiratory insufficiency (inability to breathe properly), patients with severe liver problems, and patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms. Sixmo must not be used together with medicines known as 'opioid antagonists' (naltrexone and nalmefene). It must also not be used by patients who cannot have an MRI scan and by patients who have had an excessive formation of scar tissue, as this would make locating and removing the implants more difficult. For the full list of restrictions, see the package leaflet.

Why is Sixmo authorised in the EU?

The main studies showed that Sixmo was more effective than placebo and at least as effective as sublingual buprenorphine at treating opioid dependence. While the effect of the implants tended to wear off with time in patients not previously treated with buprenorphine, it was maintained in patients who were already stable on low doses of buprenorphine and the use of Sixmo is therefore reserved for these patients. The side effects of Sixmo are those expected for a buprenorphine medicine and side effects linked to the implant itself are considered manageable.The European Medicines Agency therefore decided that Sixmo's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sixmo?

The company that markets Sixmo will set up an educational programme for doctors who are expected to prescribe Sixmo to provide detailed information about the surgical procedure for the insertion and removal of the implant. The company will also provide an alert card which patients should carry at all times and show to other healthcare professionals before receiving any medical treatment. In addition, the company will conduct a study to investigate breakages and other complications during the insertion and removal of the implants in clinical practice.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sixmo have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sixmo are continuously monitored. Side effects reported with Sixmo are carefully evaluated and any necessary action taken to protect patients.

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Skilarence

What is Skilarence and what is it used for?

Skilarence is a medicine used to treat plaque psoriasis, a disease that causes thickened, red and inflamed areas of skin with scaly patches. It is used in patients with moderate or severe disease for whom treatments applied direct to the skin do not work well enough.Skilarence contains the active substance dimethyl fumarate.

How is Skilarence used?

Skilarence can only be obtained with a prescription and it should be used under the supervision of a doctor who has experience in diagnosing and treating psoriasis.Skilarence is available as tablets (30 and 120 mg). The starting dose is 30 mg once a day and the dose is increased every week according to the schedule shown in the package leaflet until the psoriasis starts improving or until the patient is taking the maximum dose of 240 mg three times a day. Tablets should be swallowed whole during or immediately after a meal. The doctor may reduce the dose when the psoriasis has been brought under control.For further information, see the package leaflet.

How does Skilarence work?

Psoriasis results from over-activity of the body's immune (defence) system. The active substance inSkilarence, dimethyl fumarate, reduces the activity of the immune system. It is thought to act on T cells (a type of white blood cell that forms part of the immune system) to prevent the cells from producing substances that cause inflammation and lead to psoriasis.

What benefits of Skilarence have been shown in studies?

A main study involving 704 patients with moderate to severe plaque psoriasis found that Skilarence was more effective than placebo (dummy treatment) at treating the disease and as effective as Fumaderm (a psoriasis medicine that contains dimethyl fumarate and monoethyl fumarate). The main measure of effectiveness was the proportion of patients who achieved a 75% reduction in their score for disease severity. After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% taking placebo and 40% taking Fumaderm .

What are the risks associated with Skilarence?

The most common side effects with Skilarence (which may affect more than 1 in 10 people) are effects on the digestive system (diarrhoea, bloating, belly ache and nausea), flushing (reddening of the skin) and low levels of lymphocytes (type of white blood cells) or of white blood cells in general. For the full list of all side effects reported with Skilarence, see the package leaflet.Skilarence must not be used in patients who have severe problems of the digestive system, liver or kidneys. It must also not be used by women during pregnancy or if breast-feeding.

Why is Skilarence approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Skilarence's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the main study has shown Skilarence's short-term effectiveness, and published studies with similar medicines show that the effectiveness is maintained with continued use. Most side effects are mild or moderate. Because Skilarence reduces the activity of the immune system, there is a risk of serious infections, including progressive multifocal leukoencephalopathy (PML, a brain infection), but the risk can be minimised by regular tests for white blood cell counts and stopping treatment if necessary.

What measures are being taken to ensure the safe and effective use of Skilarence?

The company that markets Skilarence will supply educational materials to healthcare professionals about the risk of serious infections, including PML, and how to minimise this risk.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skilarence have also been included in the summary of product characteristics and the package leaflet.

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Skyrizi

What is Skyrizi and what is it used for?

Skyrizi is a medicine used to treat adults with:• moderate-to-severe plaque psoriasis (a disease causing red, scaly patches on the skin) who require systemic treatment (treatment with medicines given by mouth or by injection);• active psoriatic arthritis (a disease that causes psoriasis and inflammation of the joints) when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs(DMARDs) has not worked well enough or causes unacceptable side effects;• moderate-to-severe Crohn's disease (a disease causing inflammation of the digestive tract) when conventional or biological treatments do not work well enough or cause unacceptable side effects.When used for psoriatic arthritis, Skyrizi can be given alone or with another medicine, methotrexate.Skyrizi contains the active substance risankizumab.

How is Skyrizi used?

Skyrizi can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis, psoriatic arthritis or Crohn's disease.For plaque psoriasis and psoriatic arthritis, Skyrizi is available in pre-filled syringes and pre-filled pens. It is injected under the skin in an area that is clear of psoriasis, usually on the thigh or belly. The first two doses are given 4 weeks apart, while subsequent doses are given every 12 weeks. The doctor may decide to stop treatment if the condition does not improve after 16 weeks.Two formulations are used for Crohn's disease. The first, a concentrate, is used to make a solution which is given at the start of treatment as an infusion (drip into a vein) three times over eight weeks. The second formulation, a solution for injection in a cartridge, is for long-term maintenance treatment and is given as an injection under the skin 4 weeks after the last infusion and then every 8 weeks thereafter.After being trained, patients may inject Skyrizi themselves if the doctor considers it appropriate. For more information about using Skyrizi, including the recommended doses, see the package leaflet or contact your doctor or pharmacist.

How does Skyrizi work?

The active substance in Skyrizi, risankizumab, is a monoclonal antibody (a type of protein) that is designed to attach to interleukin-23 (IL-23) and block its activity. IL-23 is involved in causing inflammation that is linked to arthritis, plaque psoriasis and Crohn's disease. By blocking the action of IL-23, risankizumab reduces inflammation and other symptoms associated with these conditions.

What benefits of Skyrizi have been shown in studies?

Plaque psoriasisIn four main studies involving over 2,100 patients with moderate to severe plaque psoriasis who required systemic treatment, Skyrizi was more effective than placebo (a dummy treatment) and comparator medicines at improving symptoms.In the first two studies in a total of 997 patients, after 16 weeks of treatment around 75% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores (a measure of how severe and widespread the skin lesions are), compared with around 45% of those receiving ustekinumab and around 4% of those receiving placebo. In addition, around 86% of patients receiving Skyrizi had clear or almost clear skin, compared with around 62% of those receiving ustekinumab and around 6% of those receiving placebo. Improvements in symptoms were maintained after 52 weeks of treatment with Skyrizi.In the third study involving 605 patients, after 16 weeks of treatment 72% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 47% of those receiving adalimumab. In addition, 84% of patients receiving Skyrizi had clear or almost clear skin, compared with 60% of those receiving adalimumab.Finally, in the fourth study involving 507 patients, after 16 weeks of treatment 73% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 2% of those receiving placebo. Around 84% of patients receiving Skyrizi had clear or almost clear skin, compared with around 7% of those receiving placebo. In a second part of this study, some patients who first received Skyrizi were then switched to placebo after 28 weeks while others remained on Skyrizi. At week 52, more patients who remained on Skyrizi had clear or almost clear skin than those who were switched to placebo.Psoriatic arthritisTwo main studies involving over 1,400 patients with psoriatic arthritis showed that Skyrizi is more effective than placebo at improving symptoms.In both studies, patients received either Skyrizi or placebo and more than half of the patients were also taking methotrexate. The main measure of effectiveness was a reduction in symptoms of 20% or more based on a standard rating score (ACR20) after 24 weeks of treatment.The first study involved 443 patients whose condition had not responded adequately to previous treatment with at least one DMARD or another type of medicine known as a biological medicine. After 24 weeks, symptoms had decreased by at least 20% in 51% of patients taking Skyrizi compared with 27% of those taking placebo.The second study involved 964 patients whose psoriatic arthritis had not responded adequately to previous treatment with at least one DMARD. After 24 weeks, symptoms had decreased by at least 20% in 57% of patients taking Skyrizi compared with 34% of those taking placebo.Crohn's diseaseTwo main studies involving 1,549 patients looked at how effective Skyrizi was at treating moderate-to -severe Crohn's disease when other treatments did not work well enough or caused unacceptable side effects.In the first study, 35% of those who received the recommended dose of Skyrizi infusions over 8 weeks had a clinical remission (little or no symptoms of high stool frequency and abdominal pain) after 12 weeks while 29% of them had an endoscopic response (based on a reduction in inflammation in the intestines). The results for patients who received placebo were 19% and 11% respectively.In the second study, 44% of those who received the recommended dose of Skyrizi infusions had a clinical remission after 12 weeks while 40% of them had an endoscopic response. The results for patients who received placebo in this study were 22% and 12% respectively.A third study of 542 patients from the two main studies who responded to treatment looked at the effectiveness of maintenance treatment given under the skin every 8 weeks. After a year, around 52% of those receiving Skyrizi were in remission and 47% had an endoscopic response compared with 40% and 22% respectively of those receiving placebo.

What are the risks associated with Skyrizi?

The most common side effect with Skyrizi (which may affect more than 1 in 10 people) is upper respiratory infection (nose and throat infection).Skyrizi must not be used in patients who have an ongoing infection that the doctor considers important.For the full list of side effects and restrictions, see the package leaflet.

Why is Skyrizi authorised in the EU?

Studies have shown that Skyrizi is highly effective at clearing the skin in patients with plaque psoriasis and reduces symptoms of psoriatic arthritis; the positive effects are maintained with continued use. Skyrizi is also effective at treating symptoms of moderate to severe Crohn's disease and reducing signs of inflammation in the intestines. There are few side effects, the most important one being infection.The European Medicines Agency therefore decided that Skyrizi's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Skyrizi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skyrizi have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Skyrizi are continuously monitored. Side effects reported with Skyrizi are carefully evaluated and any necessary action taken to protect patients.

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Skytrofa (previously Lonapegsomatropin Ascendis Pharma)

What is Lonapegsomatropin Ascendis Pharma and what is it used for?

Lonapegsomatropin Ascendis Pharma is a medicine that is used to improve growth in children and adolescents who do not produce enough growth hormone (growth hormone deficiency or GHD). The medicine is intended for children and adolescents from 3 up to 18 years of age.GHD is rare, and Lonapegsomatropin Ascendis Pharma was designated an 'orphan medicine' (a medicine used in rare diseases) on 17 October 2019. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3192213.Lonapegsomatropin Ascendis Pharma contains the active substance lonapegsomatropin.

How is Lonapegsomatropin Ascendis Pharma used?

Lonapegsomatropin Ascendis Pharma can only be obtained with a prescription and treatment should be started and monitored by a doctor who is qualified and experienced in the diagnosis and treatment of GHD in children.The medicine is available as an injection of various strengths, to be given under the skin once a week. The starting dose depends on body weight and is then adjusted individually by the doctor based on response. Patients or their caregivers can inject the dose themselves after appropriate training.For more information about using Lonapegsomatropin Ascendis Pharma, see the package leaflet or contact your doctor or pharmacist.

How does Lonapegsomatropin Ascendis Pharma work?

Growth hormone is released by the pituitary gland (a gland at the base of the brain). It is important for growth during childhood and adolescence, and it also affects how the body handles proteins, fat and carbohydrates. The active substance in the medicine, lonapegsomatropin,is a version of human growth hormone (somatropin) that has been attached to a 'carrier' that protects it from being removed fromthe body too quickly. The medicine slowly releases growth hormone into the body after injection, meaning that injections do not have to be given every day

What benefits of Lonapegsomatropin Ascendis Pharma have been shown in studies?

Lonapegsomatropin Ascendis Pharma given once weekly in equivalent doses has been shown to be as effective as daily somatropin injections in a main study involving 161 patients aged 3 to 12 years with previously untreated GHD. The study measured the average rate of growth (height velocity) over a year, which was 11.2 cm per year in the group given lonapegsomatropin and 10.3 cm per year in those given daily somatropin (average growth rate in both groups before treatment was 3.9 cm per year). The company also presented the results of supportive studies including patients who had previously had growth hormone treatment.

What are the risks associated with Lonapegsomatropin Ascendis Pharma?

The most common side effects with Lonapegsomatropin Ascendis Pharma (which may affect up to around 1 in 10 people) are headache, joint pain, secondary hypothyroidism (a type of low thyroid function) and reactions at the injection site such as redness, pain, itching or swelling.For the full list of side effects of Lonapegsomatropin Ascendis Pharma, see the package leaflet.Growth hormone medicines like Lonapegsomatropin Ascendis Pharma must not be used if the patient has an active tumour or an acute life-threatening illness. The medicine must also not be used for promoting growth in children with closed epiphyses (when the large bones have finished growing). For the full list of restrictions, see the package leaflet.

Why is Lonapegsomatropin Ascendis Pharma authorised in the EU?

The European Medicines Agency decided that Lonapegsomatropin Ascendis Pharma's benefits are greater than its risks and it can be authorised for use in the EU. The medicine was shown to be effective both in patients previously treated with growth hormone and newly diagnosed patients who had not yet been treated, and the weekly injections were preferred by most patients. The short-term safety appears to be in line with other growth hormone products; although any longer-term risk from the carrier part of the active substance seems unlikely, this will be closely monitored after marketing.

What measures are being taken to ensure the safe and effective use of Lonapegsomatropin Ascendis Pharma?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lonapegsomatropin Ascendis Pharma have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lonapegsomatropin Ascendis Pharma are continuously monitored. Suspected side effects reported with Lonapegsomatropin Ascendis Pharma are carefully evaluated and any necessary action taken to protect patients.

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Slenyto

What is Slenyto and what is it used for?

Slenyto is a medicine for treating insomnia (difficulty sleeping) in children and adolescents (2 to 18 years old) who have:• autism spectrum disorder (ASD), a range of conditions that affects the patient's social interactions;• Smith-Magenis syndrome, a condition that can lead to learning difficulties.Slenyto is used after other measures such as keeping to a regular sleeping routine have not worked.The medicine contains the active substance melatonin.

How is Slenyto used?

Slenyto is available as tablets (1 and 5 mg). The normal dose is 2 mg taken 30 minutes to one hour before bedtime. The dose can be increased up to a maximum of 10 mg if the medicine is not working well enough. The doctor should review treatment regularly, at least every 6 months, and only continue treatment if the patient is benefits from it.The medicine can only be obtained with a prescription. For more information about using Slenyto, see the package leaflet or contact your doctor or pharmacist.

How does Slenyto work?

The active substance in Slenyto, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland. Melatonin is involved in coordinating the body's sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep. Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night. Patients with developmental conditions may produce less melatonin, leading to the development of insomnia. Slenyto increases levels of melatonin in the blood, helping them to sleep. Because Slenyto releases melatonin slowly over a few hours, it mimics the natural production of melatonin in the body.

What benefits of Slenyto have been shown in studies?

Slenyto has been shown to be effective at improving sleeping time in children and adolescents with neurological conditions, including autism spectrum disorder and Smith-Magenis syndrome. In a main study of 125 patients, those given Slenyto over 13 weeks slept on average for 51 extra minutes of sleep a night compared with and 19 extra minutes for those given placebo (a dummy treatment). In addition, children who took Slenyto fell asleep around 38 minutes earlier than normal while those taking placebo fell asleep 13 minutes earlier.All patients had previously tried other measures, such as keeping to a regular sleeping routine, which did not work.

What are the risks associated with Slenyto?

The most common side effects with Slenyto (which may affect up to 1 in 10 people) are sleepiness, tiredness, mood swings, headache, irritability, aggression and feeling hungover. For the full list of side effects and restrictions, see the package leaflet.

Why is Slenyto authorised in the EU?

The proportion of children with neurological conditions, such as autism spectrum disorder (ASD) and Smith-Magenis syndrome, who also have insomnia is high and not many treatments are available.Slenyto has been shown to improve sleeping times in these patients, with patients taking Slenyto sleeping for an extra 51 minutes a night compared with an extra 19 minutes with placebo. The side effects seen with the medicine over 2 years appear mild or moderate but more data are needed on longer term safety.The European Medicines Agency decided that Slenyto's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Slenyto?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Slenyto have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Slenyto are continuously monitored. Side effects reported with Slenyto are carefully evaluated and any necessary action taken to protect patients.

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Sogroya

What is Sogroya and what is it used for?

Sogroya is used as replacement therapy in adults who do not produce enough growth hormone (growth hormone deficiency). It is also used to treat children and adolescents who are not growing at the normal rate as a result of growth hormone deficiency and is given to patients from 3 years of age.Growth hormone deficiency is rare, and Sogroya was designated an 'orphan medicine' (a medicine used in rare diseases) on 24 August 2018. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182068.Sogroya contains the active substance somapacitan.

How is Sogroya used?

Sogroya is injected once a week using a pre-filled pen. It is injected under the skin in the belly, thighs, buttocks or upper arms and the injection site should be changed from one week to another. Patients or their caregivers can inject the dose themselves after appropriate training.The medicine can only be obtained with a prescription and treatment should be started and monitored by doctors who are qualified and experienced in the diagnosis and management of patients with growth hormone deficiency (such as endocrinologists).For more information about using Sogroya, see the package leaflet or contact your doctor or pharmacist.

How does Sogroya work?

The active substance in Sogroya, somapacitan, acts in the same way as human growth hormone. Once injected into the patient, it attaches to a protein in the blood called albumin, which makes it remain in the body for longer. This allows the medicine to be given once a week, compared with other growth hormone replacement therapies which are given daily.

What benefits of Sogroya have been shown in studies?

One main study involving 300 adults with growth hormone deficiency showed that Sogroya was more effective than placebo (a dummy treatment) at lowering the amount of truncal body fat (fat around the stomach and abdomen) after 34 weeks of treatment. The study also showed that weekly treatment with Sogroya had a comparable effect on truncal body fat to daily injections of somatropin (another medicine for growth hormone deficiency).Sogroya has also been studied in 200 children and adolescents (before puberty) with growth hormone deficiency who had not received growth hormone treatment before. The study showed that children who received weekly treatment with Sogroya grew at a comparable speed as children who were treated daily with somatropin.

What are the risks associated with Sogroya?

For the full list of side effects of Sogroya, see the package leaflet.The most common side effect with Sogroya (which may affect more than 1 in 10 people) is headache. Other common side effects (which may affect up to 1 in 10 people) include hypothyroidism (an underactive thyroid gland), reactions at injection site, peripheral oedema (swelling, especially of the ankles and feet), joint pain, hyperglycaemia (high blood glucose levels), tiredness and adrenocortical insufficiency (when the adrenal glands do not produce enough steroid hormones, primarily cortisol). In children and adolescents, another common side effect is pain in the arms and legs.Sogroya must not be used if the patient has an active tumour. In patients with brain tumours, tumours must be inactive and cancer therapy must have been completed before starting Sogroya. Treatment should be stopped if the tumour grows. Sogroya must also not be used in patients with acute serious illness suffering from complications after open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions. Sogroya must not be used to promote growth in children whose bones have finished growing. For the full list of restrictions, see the package leaflet.

Why is Sogroya authorised in the EU?

Sogroya was shown to be effective at lowering truncal fat percentage and improving other body composition parameters, such as lean body mass, in adults compared with placebo. Sogroya was also shown to promote growth in children and adolescents. Its effects are considered clinically relevant and comparable with those of daily somatropin injection.The short-term safety profile of Sogroya appears similar to that of other growth hormone-containing medicines, and additional data on the long-term safety and benefits of the medicine will be provided from future studies.The European Medicines Agency decided that Sogroya's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sogroya?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sogroya have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sogroya are continuously monitored. Side effects reported with Sogroya are carefully evaluated and any necessary action taken to protect patients.

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Soliris

What is Soliris and what is it used for?

Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS).These are life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. PNH results in anaemia (low red blood cell counts), thrombosis (blood clots in the blood vessels), pancytopenia (low counts of blood cells) and dark urine, while aHUS results in anaemia, thrombocytopenia (a decrease in the number of platelets, components that help the blood to clot) and kidney failure.Soliris is used to treat adults and children aged 6 years and above with myasthenia gravis (a disease where the immune system attacks and damages muscle cells causing muscle weakness), in whom other medicines do not work (refractory generalised myasthenia gravis, refractory gMG) and who have a specific antibody in their body called AChR antibody.Soliris is also used to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a disease where the immune system damages nerve cells causing problems mostly with the optic (eye) nerve and the spinal cord (nerve tissue that runs from the base of the skull down the center of the back). It is used in patients who have an antibody called AQP4 and whose disease is relapsing (where the patient has attacks [relapses] between periods with no symptoms).Soliris contains the active substance eculizumab.These diseases are rare, and Soliris was designated an 'orphan medicine' (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency's website (PNH: 17 October 2003; aHUS: 24 July 2009; myasthenia gravis: 29 July 2014; NMOSD: 24 April 2019).

How is Soliris used?

The medicine can only be obtained with a prescription and must be given under the supervision of a doctor who has experience in the management of patients with kidney disorders and disorders affecting the nervous system or the blood.Soliris is given as an infusion (drip) into a vein and the recommended dose depends on what it is used for and, for patients under 18 years of age, on the bodyweight. Soliris is given weekly initially and then every two or three weeks.Patients are monitored for any reactions during the infusion and for at least one hour afterwards. In case of any infusion-related reactions, the doctor may slow down or stop the infusion.In some patients who receive plasma exchange (the removal, treatment and return of their own blood plasma, the liquid part of the blood) or infusion of plasma, additional doses of Soliris are required.Soliris should be given for life unless the patient develops serious side effects. Treatment should also be stopped in patients with refractory gMG who do not respond to Soliris after 12 weeks.For more information about using Soliris, see the package leaflet or contact your doctor or pharmacist.

How does Soliris work?

The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body's defence system called the 'complement system'.In patients with PNH, aHUS, refractory gMG and NMOSD, the complement proteins are over-active and damage the patients' own cells. By blocking the C5 complement protein, eculizumab prevents complement proteins from damaging cells, thereby helping to relieve the symptoms of these diseases.

What benefits of Soliris have been shown in studies?

PNHFor PNH, Soliris was compared with placebo (a dummy treatment) in one main study involving 87 adults with PNH who were treated with at least four blood transfusions for anaemia in the previous year. The main measures of effectiveness were the effect of Soliris on blood levels of haemoglobin and the need for transfusions. Haemoglobin is the protein in red blood cells that carries oxygen around the body. In patients with PNH, the breakdown of red blood cells leads to a reduction in haemoglobin levels. Treatment with Soliris over 26 weeks led to stable haemoglobin levels in 49% of the patients (21 out of 43), without the need for transfusions of red blood cells. In comparison, none of the 44 patients receiving placebo had stable haemoglobin levels, and they needed an average of 10 transfusions.In a study in 7 children with PNH who were treated with at least one transfusion in the previous two years, all patients received Soliris. Six out of seven patients did not need any transfusion of red blood cells, and haemoglobin levels improved during 12 weeks of treatment with Soliris.A registry study of patients with PNH who had never had a blood transfusion looked at the blood levels of the enzyme lactate dehydrogenase (LDH). Levels of LDH rise as breakdown of red blood cells increases. The study found that treatment with Soliris for 6 months led to clinically meaningful reductions in levels of LDH, indicating reduced breakdown of red blood cells.aHUSFor aHUS, Soliris was studied in three main studies involving 67 patients. The first study involved 17 patients with aHUS who did not respond to or could not be treated with plasma exchange or infusion. Treatment with Soliris increased platelet counts in 82% of the patients, and platelet counts rose to normal levels in 87% (13 out of 15 patients) who had low platelet counts at the start. In addition, 76% achieved haematological normalisation (levels of platelets and LDH within normal levels).The second study, involving 20 patients with aHUS who were already receiving plasma exchange or infusion, resulted in 80% of the patients no longer requiring plasma exchange, infusion or dialysis and 90% of the patients achieving haematological normalisation after treatment with Soliris.The third study involved 30 patients with aHUS who had received at least one dose of Soliris. Treatment increased platelet counts to normal levels in 83% of the patients, while the platelet count rose to normal levels in 77% (10 out of 13 patients) who initially had low platelet counts.refractory gMGSoliris was compared with placebo in one main study involving 126 adults with myasthenia gravis who had previously received standard treatment which had failed. Treatment with Soliris improved patients' symptoms and their ability to undertake daily activities based on a standard scoring system. Soliris led to a reduction of 4.7 points on the scale whereas placebo led to a 2.8 point reduction after 26 weeks. A reduction in the score by 2 points indicates a clinically significant improvement of the patient's condition.Similar results were seen in children. A main study in 11 children aged above 12 years of age showed that Soliris improved symptoms and patients' ability to undertake daily activities by 5.2 and 5.8 points after 12 weeks and 26 weeks of treatment respectively. Based on these results, the medicine is expected to also work in a similar way in children aged between 6 and 12 years of age.NMOSDFor NMOSD, Soliris was compared with placebo in one main study involving 143 adults with NMOSD whose disease was relapsing. The main measure of effectiveness was the time it took until a certain number of patients experienced a relapse. After around 22 months on average, 3% of patients treated with Soliris had experienceda relapse, whereas 43% of patients treated with placebo had already a relapse after around 9 months on average.

What are the risks associated with Soliris?

For the full list of side effects and restrictions with Soliris, see the package leaflet.The most common side effect with Soliris (which may affect more than 1 in 10 people) include headache. The most serious side effect, which may affect up to 1 in 100 people, is meningococcal sepsis (when bacteria and their toxins circulate in the blood and damage the organs).Because of the increased risk of developing meningococcal sepsis, Soliris must not be given to people who have an infection caused by Neisseria meningitides; it must also not be given to patients who have not been vaccinated against this bacterium, unless they have the vaccination and take appropriate antibiotics to reduce the risk of infection for two weeks after vaccination.

Why is Soliris authorised in the EU?

Soliris was shown to benefit patients with these rare diseases. The safety profile was similar for all the diseases and was considered acceptable. The European Medicines Agency decided that Soliris' benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Soliris?

The company that markets Soliris will ensure that distribution of the medicine occurs only after checking that the patient has been vaccinated appropriately against Neisseria meningitides. The company will also provide prescribers and patients with information on the safety of the medicine, and will send reminders to prescribers and pharmacists to check if any further vaccination is needed for patients taking Soliris. Patients will also be given a card that explains the symptoms of certain types of infection, instructing patients to seek medical care immediately if they experience them.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Soliris have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Soliris are continuously monitored. Side effects reported with Soliris are carefully evaluated and any necessary action taken to protect patients.

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Somac Control

What is Somac Control?

Somac Control is a medicine that contains the active substance pantoprazole. It is available as gastroresistant tablets (20 mg). 'Gastroresistant' means that the tablet's contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance from being destroyed by the acid in the stomach.Somac Control is similar to a 'reference medicine' already authorised in the European Union (EU) called Somac.

What is Somac Control used for?

Somac Control is used for the short-term treatment of the symptoms of acid reflux in adults. Acid reflux is when acid produced in the stomach escapes into the gullet, causing heartburn and acid regurgitation (acid flowing up into the mouth).The medicine can be obtained without a prescription.

How is Somac Control used?

The recommended dose of Somac Control is one tablet once a day until symptoms have stopped. The patient may need to take the medicine for two to three days in a row for symptoms to improve. If there is no improvement in symptoms within two weeks of continuous treatment, patients shouldconsult their doctor. Patients should not take the medicine for longer than four weeks without consulting their doctor.The tablets should be swallowed whole with liquid before a meal and should not be chewed or crushed.

How does Somac Control work?

The active substance in Somac Control, pantoprazole, is a proton pump inhibitor. It works by blocking 'proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach. By blocking the pumps, pantoprazole reduces acid production, relieving the symptoms of acid reflux.Pantoprazole-containing medicines have been available in the European Union (EU) since 1994. The reference medicine, Somac, is only available with a prescription. It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Somac Control.

How has Somac Control been studied?

Because pantoprazole has been in use for many years, the applicant presented data from the scientific literature. The applicant also presented information from two main studies looking at the effects of pantoprazole 20 mg in a total of 563 adults who had symptoms of acid reflux, including at least one episode of heartburn in the three days before the studies began. The first study compared pantoprazole with placebo (a dummy treatment) in 219 adults, and the second compared it with ranitidine (another medicine used to treat acid reflux symptoms) in 344 adults. The main measure of effectiveness was the number of patients with symptoms of heartburn over the first two weeks of treatment.

What benefit has Somac Control shown during the studies?

Pantoprazole was more effective than placebo and ranitidine at improving the symptoms of acid reflux. In the first study, 74% of the patients taking pantoprazole (80 out of 108) and 43% of those taking placebo (48 out of 111) had no heartburn after two weeks. Pantoprazole was also more effective than placebo at reducing symptoms of acid regurgitation. In the second study, 70% of the patients taking pantoprazole (121 out of 172) and 59% of those talking ranitidine (102 out of 172) had no heartburn after two weeks of treatment.

What is the risk associated with Somac Control?

The most common side effects with Somac Control (seen in around 1 patient in 100) are diarrhoea and headache. For the full list of all side effects reported with Somac Control, see the package leaflet.Somac Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients. It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).

Why has Somac Control been approved?

The CHMP noted that pantoprazole 20 mg was effective in the short-term treatment of reflux symptoms and that there is a long safety experience with the medicine as a prescription medicine. It was also of the opinion that, based on the experience of the use of pantoprazole, the availability ofSomac Control without medical supervision is appropriate. The CHMP therefore decided that Somac Control's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Somakit Toc

What is SomaKit TOC and what is it used for?

SomaKit TOC is a diagnostic medicine used in adult patients who are thought to have so-called welldifferentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs). GEP-NETs are cancers which start in types of cells in the gut or pancreas that normally release hormones. The tumours can then spread elsewhere in the body (metastasis).SomaKit TOC is used with a technique called positron emission tomography (PET scan) to obtain images that locate the cancers. SomaKit TOC contains the active substance edotreotide. The medicine is not used directly, but must be 'radiolabelled' before being injected, which means that it is tagged with a separate substance that emits small amounts of radiation. The substance that is used for radiolabelling SomaKit TOC is called gallium (68Ga) chloride.Because the number of patients with GEP-NETs is low, the disease is considered 'rare', and SomaKit TOC was designated an 'orphan medicine' (a medicine used in rare diseases) on 19 March 2015.

How is SomaKit TOC used?

SomaKit TOC is available as a kit for preparing a solution for injection. It is given as a single injection into a vein immediately after being radiolabelled. The PET scan images are then taken 40 to 90 minutes later.SomaKit TOC can only be obtained with a prescription and the injection must only be prepared and given in a suitable facility by experts in handling radioactive medicines.For further information, see the package leaflet.

How does SomaKit TOC work?

The active substance in SomaKit TOC, edotreotide, attaches specifically to receptors called somatostatin receptors on the surface of cells. Not all cells have these receptors but most welldifferentiated GEP-NET cells have high amounts on their surface. The prepared medicine, radiolabelled with gallium (68Ga) chloride, attaches to these receptors on the GEP-NET cells. The resulting build-up of radiation can be detected by the special camera of the PET scan. This makes it possible to see where the tumours are and whether they have spread.

What benefits of SomaKit TOC have been shown in studies?

The active substance in SomaKit TOC, edotreotide radiolabelled with gallium (68Ga) chloride, has a well established use in detecting GEP-NETs. The company therefore provided information from many, mostly small, studies in the published literature to show the effectiveness of SomaKit TOC at detection.The studies included data from 970 patients. Some studies looked at the sensitivity of the PET scans (how well the scans identified patients who had GEP-NETs or their metastases), some analysed specificity (how reliable scans were at identifying subjects who had no GEP-NETs) and some looked at lesion detection rate (how good scans were at identifying the tumours). A comparison using data from several of these studies (a meta-analysis) was also presented.Taken together, the studies were sufficient to show the effectiveness of SomaKit TOC for detection, although the exact results varied. For localising the primary GEP-NET, one study showed that the medicine had a sensitivity of 45% compared with 10% in patients given another approved diagnostic medicine, indium (111In) pentetreotide, and this was confirmed by another study that showed that the former had better sensitivity. Results of further studies indicated that edotreotide labelled with gallium (68Ga) chloride had a sensitivity and specificity of 100% and 89% respectively, and found a lesion detection rate of 75%.In four other comparative studies it was seen that the active substance in SomaKit TOC detected more tumours than did indium (111In) pentetreotide in the same patients.

What are the risks associated with SomaKit TOC?

After SomaKit TOC is radiolabelled it emits a small amount of radiation which poses a low risk of cancer or hereditary abnormalities.For the full list of side effects or restrictions with SomaKit TOC, see the package leaflet.

Why is SomaKit TOC approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the technical and diagnostic performance of the medicine had been demonstrated. The risks of side effects seemed to be low and the CHMP therefore decided that SomaKit TOC's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of SomaKit TOC?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of SomaKit TOC have been included in the summary of product characteristics and the package leaflet.

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Somavert

What is Somavert and what is it used for?

Somavert is a medicine used to treat adults with acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).Somavert contains the active substance pegvisomant.

How is Somavert used?

Somavert can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of acromegaly. Somavert is available as powder and solvent that are mixed together to make up a solution for injection under the skin.Before starting and during treatment with Somavert, the patient should have tests to measure levels of liver enzymes in the blood. If levels are too high, the doctor may decide not to begin or to stop treatment with Somavert.The patient first receives a starting dose of 80 mg under medical supervision. Following this, Somavert is given as an injection of 10 mg once a day. The patient or caregiver can inject Somavert after being trained by a doctor or a nurse. The doctor should check the response every four to six weeks and adjust the dose if needed. The maximum dose is 30 mg per day.For more information about using Somavert, see the package leaflet or contact your doctor or pharmacist.

How does Somavert work?

Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour. Growth hormone promotes growth during childhood and adolescence. In adults, rather than gaining height, overproduction of growth hormone leads to acromegaly, with overgrowth of bone, swelling of soft tissue (such as the hands and feet),heart disease and other disorders. The active substance in Somavert, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally attaches itself. By blocking the receptors, Somavert prevents growth hormone from having an effect, thereby preventing the unwanted growth and other disorders seen in acromegaly.

What benefits of Somavert have been shown in studies?

Somavert has been studied in 112 patients with acromegaly in a 12-week study. Patients received a starting dose of 80 mg Somavert or placebo (a dummy treatment). Afterwards, they received 10, 15 or 20 mg Somavert per day or placebo. The effectiveness was measured by comparing the levels of insulin-like growth factor-I (IGF-I) before and at the end of the study. IGF-I is regulated by human growth hormone and causes growth in the body.Somavert lowered IGF-I levels at all of the doses tested. IGF-I levels were normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/day Somavert, respectively, compared with 9.7% of the patients treated with placebo.

What are the risks associated with Somavert?

The most common side effects of Somavert (seen in more than 1 in 10 people) were headache, diarrhoea and joint pain. The majority of side effects were mild to moderate and of limited duration.For the full list of side effects and restrictions with Somavert, see the package leaflet.

Why is Somavert authorised in the EU?

The European Medicines Agency decided that Somavert's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Somavert?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Somavert have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Somavert are continuously monitored. Side effects reported with Somavert are carefully evaluated and any necessary action taken to protect patients.

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Sondelbay

What is Sondelbay and what is it used for?

Sondelbay is a medicine used for the treatment of osteoporosis (a disease that makes the bones fragile) in:• women who have been through the menopause;• men who have an increased risk of fractures;• men and women who have an increased risk of fracture due to long-term treatment with glucocorticoids (a type of steroid).Sondelbay is a 'biosimilar medicine'. This means that Sondelbay is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Sondelbay is Forsteo. For more information on biosimilar medicines, see here.Sondelbay contains the active substance teriparatide.

How is Sondelbay used?

Sondelbay is available in pre-filled pens as a solution for injection under the skin. The recommended dose is 20 micrograms of Sondelbay injected once a day under the skin of the thigh or belly. Patients may inject themselves once they have been trained.Patients should take calcium and vitamin D supplements if they do not get enough from their diet. Sondelbay can be used for up to two years. The two-year course should be given only once during a patient's lifetime.The medicine can only be obtained with a prescription. For more information about using Sondelbay, see the package leaflet or contact your doctor or pharmacist.

How does Sondelbay work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become less dense and more likely to break. In women, osteoporosis ismore common after the menopause, when the levels of the female hormone oestrogen fall.Osteoporosis can also occur as a side effect of glucocorticoid treatment in men and women.The active substance in Sondelbay, teriparatide, is identical to part of the human parathyroid hormone. It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells). It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.

What benefits of Sondelbay have been shown in studies?

Laboratory studies comparing Sondelbay with Forsteo have shown that the active substance inSondelbay is highly similar to that in Forsteo in terms of structure, purity and biological activity. Studies have also shown that giving Sondelbay produces similar levels of the active substance in the body to giving Forsteo.Because Sondelbay is a biosimilar medicine, the studies on effectiveness and safety of teriparatide carried out with Forsteo do not all need to be repeated for Sondelbay.

What are the risks associated with Sondelbay?

The safety of Sondelbay has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Forsteo.The most common side effect with teriparatide (which may affect more than 1 in 10 people) is pain in the arms or legs; nausea (feeling sick), headache and dizziness are also common. For the full list of side effects of Sondelbay, see the package leaflet.Sondelbay must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme that can be a sign of bone disease) or severe kidney disease. Sondelbay must not be used during pregnancy or breastfeeding. For the full list of restrictions, see the package leaflet.

Why is Sondelbay authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Sondelbay has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way.All these data were considered sufficient to conclude that Sondelbay will behave in the same way as Forsteo in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Forsteo, the benefits of Sondelbay outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sondelbay?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sondelbay have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sondelbay are continuously monitored. Suspected side effects reported with Sondelbay are carefully evaluated and any necessary action taken to protect patients.

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Sonovue

What is SonoVue and what is it used for?

SonoVue is a medicine for diagnostic use only. It is a contrast agent (it helps make internal body structures visible during imaging tests). SonoVue is used in tests that measure how ultrasound travels within the body because it improves the ability to create an echo. It is only used when the results of the test without a contrast agent are inconclusive. SonoVue is used in:• echocardiography (a diagnostic test where an image of the heart is obtained). It is used to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, in adults with suspected or confirmed coronary artery disease;• Doppler (a diagnostic test that measures the speed of blood flow). SonoVue can be used in adults for Doppler tests for large blood vessels, such as those in the head, those leading to the head or the main vein to the liver, or for smaller blood vessels such as those in lesions (areas of disease) in the breast or liver;• ultrasound scans of the bladder and urinary tract in children and adolescents to detect vesicoureteral reflux, a condition in which urine flows backward from the bladder to the kidneys, leading to scarring and kidney infections.The medicine contains the active substance sulphur hexafluoride (a gas).

How is SonoVue used?

SonoVue can only be obtained with a prescription and should only be used by doctors who have experience in diagnostic ultrasound imaging. It is available as a kit including one vial of gas and powder and one pre-filled syringe containing 5 ml of solvent. When made up into a solution, SonoVue contains sulphur hexafluoride gas as 'microbubbles' in suspension in a liquid.When used with ultrasound of the heart or for measuring blood flow, SonoVue is injected intravenously (into a vein) before the test is carried out, as a 2 or 2.4 ml dose depending on which test is being carried out. The dose can be repeated. When used to detect vesicoureteral reflux in children, 1 ml of SonoVue is given by a catheter into the bladder, which is then filled with saline (salt) solution until the patient feels the need to empty their bladder. The ultrasound scan of the bladder and kidneys is carried out during filling and emptying of the bladder.

How does SonoVue work?

The active substance in SonoVue, sulphur hexafluoride, is a gas that is not soluble in body fluids or water. When SonoVue is made up into a suspension, the gas is trapped in tiny bubbles called microbubbles. After injection, the microbubbles travel in the blood or disperse throughout the bladder, where they reflect ultrasound waves more than the surrounding tissues. This helps to enhance the results of tests that rely on measuring ultrasound. The gas is removed naturally from the blood through the lungs or passed out in the urine after bladder scans.

What benefits of SonoVue have been shown in studies?

For use in echocardiography, SonoVue was investigated in 3 main studies. These involved a total of 317 patients, and compared SonoVue with another contrast agent and placebo (a dummy treatment). SonoVue was more effective than the comparator and than placebo in improving the clarity of the image obtained of the left ventricle and left ventricle border.For use in Doppler scans, a further 3 main studies involved 361 patients who were being tested for abnormalities in large blood vessels, and 217 patients being tested for abnormalities in smaller vessels. In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared with the 'gold standard', such as angiography (X-rays of blood vessels). The main measure of effectiveness was how clear the images obtained in the test were. Using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys). For the smaller vessels, SonoVue led to better quality scans when looking at the blood flow in breast and liver lesions. However, this was not observed in the pancreas, kidney, ovary or prostate gland.The company also presented results from the literature of 4 main studies involving over 500 children given SonoVue before ultrasound scans of the bladder to detect vesicoureteral reflux. Ultrasound with SonoVue was compared with the standard method using X-rays with an X-ray contrast agent. Pooled analysis of the studies suggested that SonoVue identified children with vesicoureteral reflux in 89% of cases, and correctly distinguished patients who did not have the condition in 81% of cases. However, the results were not sufficient to state that a negative result following ultrasound with Sonovue allows the practitioner to exclude a diagnosis of vesicoureteral reflux.

What are the risks associated with SonoVue?

The most common side effects when SonoVue is injected into a vein (seen in up to 1 in 100 patients) are headache, nausea (feeling sick) and reactions at the injection site. No side effects attributable to the medicine have been reported in children given SonoVue into the bladder. For the full list of all side effects reported with SonoVue, see the package leaflet.SonoVue must not be injected into a vein in patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs).SonoVue must also not be used together with the medicine dobutamine (used for heart failure) in patients for whom dobutamine is not suitable. For the full list of restrictions, see the package leaflet.

Why is SonoVue approved?

SonoVue has been shown to be effective in improving ultrasound scans of the heart in adults and the bladder in children, and in measurements of blood flow. Side-effects were generally minor. The European Medicines Agency therefore decided that SonoVue's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of SonoVue?

The company will carry out a study to confirm the effectiveness of SonoVue in detecting vesicoureteral reflux in children and its impact on the way patients are managed.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of SonoVue have also been included in the summary of product characteristics and the package leaflet.

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Sorafenib Accord

What is Sorafenib Accord and what is it used for?

Sorafenib Accord is a cancer medicine used to treat patients who have the following diseases:• hepatocellular carcinoma (a type of liver cancer);• advanced renal cell carcinoma (a type of kidney cancer) when cancer treatment with interferon alpha or interleukin-2 has failed or cannot be used;Sorafenib Accord contains the active substance sorafenib.Sorafenib Accord is a 'generic medicine'. This means that Sorafenib Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Nexavar. For more information on generic medicines, see the question-and-answer document here.

How is Sorafenib Accord used?

Sorafenib Accord can only be obtained with a prescription. Treatment with Sorafenib Accord should be supervised by doctors who have experience in using cancer treatments.Sorafenib Accord is given as two tablets twice a day, without food or with a meal that has a low or moderate fat content. Treatment should continue as long as the patient continues to benefit from it without too many side effects. To manage side effects, treatment may be temporarily interrupted or the dose may be reduced.For more information about using Sorafenib Accord, see the package leaflet or contact your doctor or pharmacist.

How does Sorafenib Accord work?

The active substance in Sorafenib Accord, sorafenib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases that are involved in the growth and spread of cancer cells, as well as in the development of new blood vessels supplying the tumours. By blocking these enzymes, Sorafenib Accord can reduce the growth of cancer cells and cut off the blood supply that keeps them growing.Send

How has Sorafenib Accord been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Nexavar, and do not need to be repeated for Sorafenib Accord.As for every medicine, the company provided studies on the quality of Sorafenib Accord. The company also carried out a study that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Sorafenib Accord?

Because Sorafenib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sorafenib Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Sorafenib Accord has been shown to have comparable quality and to be bioequivalent to Nexavar. Therefore, the Agency's view was that, as for Nexavar, the benefits of Sorafenib Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sorafenib Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sorafenib Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sorafenib Accord are continuously monitored. Suspected side effects reported with Sorafenib Accord are carefully evaluated and any necessary action taken to protect patients.

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Sotyktu

What is Sotyktu and what is it used for?

Sotyktu is a medicine for treating adults with moderate to severe plaque psoriasis (an inflammatory disease causing red, scaly patches on the skin) who are eligible for systemic therapy (treatment with a medicine given by mouth or by injection).Sotyktu contains the active substance deucravacitinib.

How is Sotyktu used?

Sotyktu can only be obtained with a prescription. Treatment should be started by a doctor experienced in the diagnosis and treatment of psoriasis.Sotyktu is available as tablets, which the patient takes once a day. The doctor should evaluate the effect of the treatment regularly and may stop treatment if the condition does not improve after 24 weeks.For more information about using Sotyktu, including dose recommendations, see the package leaflet or contact your doctor or pharmacist.

How does Sotyktu work?

The active substance in Sotyktu, deucravacitinib, blocks the action of an enzyme inside cells called tyrosine kinase 2 (TYK2) which belongs to the Janus kinases (JAK) family of proteins. This enzyme plays a role in triggering the production of substances known as cytokines, which are involved in the inflammation and other processes that cause psoriasis. By blocking the action of TYK2, deucravacitinib prevents the production of cytokines, thereby reducing inflammation and improving the symptoms of plaque psoriasis.

What benefits of Sotyktu have been shown in studies?

Two main studies involving 1,686 patients with moderate to severe plaque psoriasis compared Sotyktu with placebo (a dummy treatment) and apremilast, another systemic therapy for plaque psoriasis. The studies looked at an improvement of patients' symptoms after 16 weeks of treatment.Around 55% of patients treated with Sotyktu had a reduction of at least 75% in their PASI score (a measure of the severity and extent of skin lesions) compared with around 38% of those treated with apremilast and around 11% of those who received placebo.Additionally, around 51% of patients treated with Sotyktu achieved a sPGA score (a measure of the severity and extent of skin lesions) of 0 or 1 (where 0 and 1 refer to skin clear or almost clear, respectively) and had a reduction of 2 points or more in their sPGA score. Around 33% of those treated with apremilast and around 8% in those who received placebo had these results.Improvement of symptoms were maintained after 52 weeks of treatment with Sotyktu.

What are the risks associated with Sotyktu?

The most common side effect with Sotyktu (which may affect more than 1 in 10 people) is upper respiratory infection (nose and throat infection). For the full list of side effects of Sotyktu, see the package leaflet.Patients who have an important or long-term infection, or an infection that keeps coming back, must not take this medicine. For the full list of restrictions, see the package leaflet.

Why is Sotyktu authorised in the EU?

Studies show that Sotyktu is effective at reducing the symptoms of moderate to severe plaque psoriasis. Side effects are mild to moderate and manageable. Sotyktu provides an additional treatment option for patients who have not yet been treated with systemic therapy and those who do not benefit from other systemic therapies. Therefore, the European Medicines Agency decided that Sotyktu's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sotyktu?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sotyktu have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sotyktu are continuously monitored. Suspected side effects reported with Sotyktu are carefully evaluated and any necessary action taken to protect patients.

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Sovaldi

What is Sovaldi and what is it used for?

Sovaldi is an antiviral medicine used in combination with other medicines to treat adults and children from 3 years of age with chronic (long-term) hepatitis C, an infection caused by the hepatitis C virus that affects the liver.Sovaldi contains the active substance sofosbuvir.

How is Sovaldi used?

Sovaldi can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.Sovaldi is available as tablets and granules in a sachet. The granules are suitable for children and patients who cannot take tablets and they can be sprinkled on soft food, swallowed with water or swallowed dry without chewing.For adults, the recommended dose of Sovaldi is 400 mg sofosbuvir once a day. For children and young people aged up to 18 years, the daily dose depends on their weight. Sovaldi is normally taken for 12 or 24 weeks.Sovaldi must be used in combination with other medicines used to treat chronic hepatitis C, such as ribavirin or peginterferon alfa (a form of the natural substance, interferon) and ribavirin. Sovaldi can be used in all 6 varieties (genotypes) of hepatitis C virus. For children, Sovaldi is recommended for genotypes 2 or 3. The duration of treatment will depend on the genotype of the virus the patient is infected with and on which medicines are used with Sovaldi.For further information about using Sovaldi, see the package leaflet or contact your doctor or pharmacist.

How does Sovaldi work?

The active substance in Sovaldi, sofosbuvir, blocks the action of a protein called NS5B RNA-dependent RNA polymerase in the hepatitis C virus, which is essential for the virus to multiply. This stops the hepatitis C virus from multiplying and infecting new cells.

What benefits of Sovaldi have been shown in studies?

Sovaldi has been investigated in four main studies involving a total of 1,305 adult patients infected with hepatitis C. In all four studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment.• The first study involved 327 previously untreated patients who were infected with hepatitis C virus of genotypes 1, 4, 5 or 6, and who were given Sovaldi together with two other antiviral medicines, peginterferon alfa and ribavirin, for 12 weeks. In this study, 91% (296 out of 327) of patients had no sign of the virus 12 weeks after the end of treatment.• The second study involved 499 previously untreated patients who had hepatitis C of genotypes 2 or 3. In this study, patients given Sovaldi together with ribavirin for 12 weeks were compared with patients given peginterferon alfa and ribavirin for 24 weeks. Treatment with Sovaldi was as effective (67% patients - 171 out of 256 - had no sign of the virus) as peginterferon-based treatment (67% of patients - 162 out of 243).• The third study involved 278 patients with genotypes 2 or 3 hepatitis C virus who could not take or did not want to have treatment with interferon. This study investigated 12 weeks of treatment with Sovaldi and ribavirin compared with placebo (a dummy treatment) and found that 78% (161 out of 207) of patients taking Sovaldi and ribavirin had no sign of the hepatitis C virus 12 weeks after treatment, whereas none of 71 patients taking placebo were free of the virus.• The fourth study involved 201 patients with hepatitis C virus (genotypes 2 or 3) whose infection did not improve on previous treatment with interferon or whose infections came back. This study compared Sovaldi and ribavirin taken for 12 weeks with Sovaldi and ribavirin taken for 16 weeks. In this study, 50% (51 out of 103) of patients taking Sovaldi and ribavirin for 12 weeks had no sign of the hepatitis C virus, compared with 71% (70 out of 98) of patients treated for 16 weeks.• A fifth study involved 106 children and adolescents aged 3 to 17 years with hepatitis C virus (genotypes 2 or 3) who were treated with Sovaldi and ribavirin for 12 or 24 weeks. Around 98% of patients (51 out of 52) aged 12 to 17 years and 100% (41 out of 41) children aged from 6 to 11 years had no sign of the hepatitis C virus after treatment. In children aged 3 to 6 years, 4 out of 5 infected with the genotype 2 virus were cleared of the virus and all 8 infected with the genotype 3 virus were cleared of the virus.Additional studies showed that Sovaldi in combination with ribavirin decreased the risk of infection of the new liver with hepatitis C virus in adult patients undergoing transplantation, that Sovaldi is also effective in patients infected with both hepatitis C and HIV, and that the outcome of patients with genotype 3 infection could be improved by extending treatment to 24 weeks.

What are the risks associated with Sovaldi?

The most common side effects with Sovaldi in combination with ribavirin and peginterferon alfa were similar to those commonly reported with ribavirin or peginterferon alfa and included tiredness, headache, nausea (feeling sick) and insomnia (difficulty sleeping). For the full list of side effects of Sovaldi, see the package leaflet.Sovaldi must not be used together with certain types of medicines which can reduce the effects of Sovaldi. Such medicines include:• rifampicin (an antibiotic for serious infections like tuberculosis);• St. John's wort (a herbal preparation used to treat depression and anxiety);• carbamazepine, phenobarbital and phenytoin (medicines for epilepsy).For the full list of restrictions, see the package leaflet.

Why is Sovaldi authorised in the EU?

The European Medicines Agency decided that Sovaldi's benefits are greater than its risks and it can be authorised for use in the EU. Sovaldi allows the virus to be cleared without the patient having to take peginterferon alfa or with only short courses of this medicine (which can cause serious side effects, including reduced growth in adolescents).The Agency also considered that giving Sovaldi in combination with ribavirin before a liver transplant can prevent re-infection of the liver, which in the absence of treatment occurs nearly always and results in a poor prognosis. In addition, virus resistance to Sovaldi is rare and Sovaldi works against all types of hepatitis C virus.Regarding safety, the Agency noted that, although there is limited information in some groups of patients such as those with decompensated liver disease (where the liver is damaged and no longer works properly), no side effects specific to Sovaldi have been identified, and those that occur are mainly due to combined treatment with ribavirin or interferons.

What measures are being taken to ensure the safe and effective use of Sovaldi?

The company that markets Sovaldi will carry out a study in patients who have had liver cancer to evaluate the risk of the cancer returning after treatment with direct-acting antivirals such as Sovaldi. The study is being carried out because of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sovaldi have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sovaldi are continuously monitored. Side effects reported with Sovaldi are carefully evaluated and any necessary action taken to protect patients.

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Spectrila

What is Spectrila and what is it used for?

Spectrila is used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts, in combination with other cancer medicines. It contains the active substance asparaginase.

How is Spectrila used?

Spectrila is given every 3 days by infusion (drip) into a vein, with the dose depending on the patient's age and body surface area.Only healthcare professionals experienced in cancer treatments should prescribe and give Spectrila. The healthcare professional should only give the medicine in a hospital setting where resuscitation equipment is available. For further information, see the package leaflet.Spectrila can only be obtained with a prescription and is available in a vial as a powder to be made into a solution for infusion.

How does Spectrila work?

The active substance in Spectrila, asparaginase, is an enzyme that works by breaking up and reducing the blood levels of the amino acid asparagine. The cancer cells need this amino acid to grow andmultiply, and so its reduction in the blood causes the cells to die. Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.

What benefits of Spectrila have been shown in studies?

In a study in 199 children with ALL, Spectrila was as effective as another asparaginase medicine (both used in combination with other medicines) in reducing blood asparagine: 95% of patients treated with Spectrila and 94% of those treated with the other medicine containing asparaginase had complete depletion (reduction) of blood asparagine.

What are the risks associated with Spectrila?

The most common side effects with Spectrila (which may affect more than 1 in 10 people) are allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing), diarrhoea, nausea, vomiting, abdominal pain, tiredness, swelling (caused by fluid build-up), high blood sugar, and low blood levels of albumin (a protein) and other abnormalities in blood tests. For the full list of side effects reported with Spectrila, see the package leaflet.The most serious side effects with Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas), and liver problems.Spectrila must not be used in patients who are allergic to any asparaginase preparation and those who have pancreatitis (inflammation of the pancreas), severe liver disease or blood clotting problems. It must also not be used in patients who have ever had pancreatitis, or severe bleeding or blood clots following asparaginase treatment. For the full list of restrictions, see the package leaflet.

Why is Spectrila approved?

Spectrila is effective at reducing blood asparagine that the cancer cells need to survive. Although the data in adults are limited, there is substantial clinical experience of asparaginase medicines in adults, and the benefits of Spectrila in adults can be expected to be similar.As for its risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine's risk minimisation plan.The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Spectrila are greater than the risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Spectrila?

A risk management plan has been developed to ensure that Spectrila is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spectrila, including the appropriate precautions to be followed by healthcare professionals and patients.

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Spedra

What is Spedra and what is it used for?

Spedra is a medicine used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Spedra to be effective, sexual stimulation is required.Spedra contains the active substance avanafil.

How is Spedra used?

Spedra is available as tablets (50, 100 and 200 mg) and can only be obtained with a prescription. The recommended dose is 100 mg, taken approximately 15 to 30 minutes before sexual activity; patients should not take more than one dose a day. Spedra may be taken with or without food. If it is taken with food, it may take longer to work. The dose may be adjusted if necessary; lower doses may be needed in patients with liver problems or who are taking certain other medicines.For further information, see the package leaflet.

How does Spedra work?

The active ingredient in Spedra, avanafil, belongs to a group of medicines called phosphodiesterasetype-5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexualstimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Spedra enhances its effect on erectile function. Sexual stimulation is still needed to produce an erection.

What benefits of Spedra have been shown in studies?

Spedra has been studied in three main studies involving over 3,400 men with erectile dysfunction. The first study involved men from the general population, but because certain conditions associated with erectile dysfunction might affect response to treatment the second study looked mainly at men who had erectile dysfunction and diabetes, and the third was in men who had erectile dysfunction after surgery on the prostate gland. In these studies, which lasted for 12 weeks, different doses of Spedra taken approximately 30 minutes before sexual activity were compared with placebo (a dummy tablet). The main measures of effectiveness in all three studies were the percentage of erections that lasted long enough for successful intercourse, the percentage of successful vaginal penetrations, and the change in an assessment score for erectile function.Spedra was more effective than placebo in all studies. The results of the first study showed that Spedra taken approximately 30 minutes before sexual activity at a dose of 100 or 200 mg increased the percentage of successful attempts at intercourse from about 13% before treatment to about 57%, whereas placebo only increased it to 27%. The medicine also produced about 20% more successful vaginal penetrations than placebo. The improvement in assessment score was about 5 to 7 points more than with placebo.An additional study involving 440 adults with erectile dysfunction was also carried out, where Spedra was taken approximately 15 minutes before sexual activity. The percentage of successful attempts was about 28% with Spedra at a dose of 200 mg and about 25% with a dose of 100 mg, compared with 14% with placebo.

What are the risks associated with Spedra?

The most common side effects with Spedra (which may affect up to 1 in 10 people) are headache, flushing (reddening of the skin) and nasal congestion; back pain has also been reported and may affect up to 1 in 100 people. For the full list of all side effects reported with Spedra, see the package leaflet.Doctors should consider the potential risks of sexual activity for the heart in men who have heart disease before prescribing Spedra. The medicine must not be used by patients with certain serious heart or circulatory problems, including those who have had a heart attack, stroke, or serious arrhythmia (irregularity of the heart rhythm) in the last six months and those who have unstable angina (a severe type of chest pain), angina during sexual intercourse, heart failure, or high or low blood pressure. It must also not be used by patients who have severely reduced liver or kidney function, or who have had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischaemic optic neuropathy, NAION) that can be triggered by this class of medicines.Spedra must not be taken with certain other medicines including nitrates (a type of medicine used for angina) or medicines that strongly reduce the breakdown of Spedra in the body. For the full list of restrictions, see the package leaflet.

Why is Spedra approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Spedra was more effective than placebo in allowing successful intercourse. However, the fact that it was not compared directly with other medicines in its class made it hard to evaluate its potential place in treating erectile dysfunction. Regarding its safety, side effects were similar to other medicines of its class. The Committee therefore considered that Spedra's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Spedra?

A risk management plan has been developed to ensure that Spedra is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spedra, including the appropriate precautions to be followed by healthcare professionals and patients.

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Spevigo

What is Spevigo and what is it used for?

Spevigo is a medicine that acts on the immune system. It is used in adults to treat flare-ups (recurrence or worsening) of generalised pustular psoriasis, an inflammatory skin disease causing pustules (pus-filled lesions) to appear over large areas of skin.Spevigo contains the active substance spesolimab.

How is Spevigo used?

Spevigo can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in managing inflammatory skin diseases.The medicine is given once as an infusion (drip) into a vein over 90 minutes; a second dose can be given one week later if symptoms are still present.For more information about using Spevigo, see the package leaflet or contact your doctor or pharmacist.

How does Spevigo work?

The active substance in Spevigo, spesolimab, is a monoclonal antibody (a type of protein) that binds to and blocks the receptor (target) for a protein involved in inflammation called interleukin-36 (IL-36). By preventing IL-36 from attaching to its receptor, Spevigo reduces inflammation and improves the symptoms of generalised pustular psoriasis.

What benefits of Spevigo have been shown in studies?

A main study involving 53 adults with generalised pustular psoriasis flare-ups of moderate to severe intensity showed that Spevigo was more effective than placebo (a dummy treatment) at improving symptoms of the disease. After one week, 54% (19 out of 35 patients) of those who received a single dose of Spevigo had no visible pustules compared with 6% (1 out of 18 patients) of those who were given placebo, as measured using the GPPGA pustulation subscore (a measure of the severity of the pustules).

What are the risks associated with Spevigo?

The most common side effects with Spevigo (which may affect more than 1 in 10 people) are infections.For the full list of side effects of Spevigo, see the package leaflet.Spevigo must not be given to patients who have an active infection that the doctor considers important or those with severe or life-threatening hypersensitivity (allergy) to any of the medicine's ingredients.

Why is Spevigo authorised in the EU?

The severity of generalised pustular psoriasis flare-ups varies but can lead to organ failure and sepsis (blood poisoning). The disease is therefore a considerable burden on patients' lives. At the time of approval, there were no approved treatments for flare-ups of generalised pustular psoriasis and most therapies used in clinical practice had limited data on safety and efficacy.Spevigo has been shown to be effective in clearing pustules within one week following a flare-up.Although safety data are limited, the safety profile is considered manageable.Spevigo has been given 'conditional authorisation'. This means that that the European Medicines Agency decided that the benefits of Spevigo are greater than its risks, but the company will have to provide additional evidence after authorisation.Conditional authorisation is granted on the basis of less comprehensive data than are normally required. It is granted for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. Every year, the Agency will review any new information that becomes available until data become comprehensive and this overview will be updated as necessary.

What information is still awaited for Spevigo?

Since Spevigo has been given conditional authorisation, the company that markets the medicine will provide data from a study of the medicine in the treatment of recurrent flare-ups in patients with generalised pustular psoriasis to confirm its safety and effectiveness.

What measures are being taken to ensure the safe and effective use of Spevigo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spevigo have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Spevigo are continuously monitored. Suspected side effects reported with Spevigo are carefully evaluated and any necessary action taken to protect patients.

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Spherox

What is Spherox and what is it used for?

Spherox is a medicine used to repair defects to the cartilage in the knee in patients who are experiencing symptoms (such as pain and problems moving the knee). It is used where the affected area is no larger than 10 cm². Spherox is used in adults and in adolescents whose bones in the joints have finished growing.Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage, that have been prepared from the patient's own tissues.

How is Spherox used?

Spherox is available as a suspension for implantation into the knee joint. The medicine is prepared specifically for each individual patient and must be given by a qualified doctor in a medical facility.To prepare the medicine, a small sample is taken by arthroscopy (a type of keyhole surgery) from the patient's cartilage in the knee. The cartilage cells are then grown in the laboratory to prepare a suspension of chondrocyte spheroids. During another arthroscopy, the medicine is placed into the damaged area of the patient's cartilage in the knee. The chondrocyte spheroids attach to the cartilage within 20 minutes. Patients treated with Spherox should follow a specific rehabilitation programme, including physiotherapy. This allows the chondrocyte spheroids to fill in the cartilage defect.The medicine can only be obtained with a prescription.

How does Spherox work?

Cartilage in the knee can be damaged because of an accident, such as a fall or a sports injury. Spherox contains spheroids made from the patient's own healthy cartilage cells. When the spheroids are implanted into the patient's knee cartilage, they attach to the area of the defect and produce new tissue, thereby repairing the defects in the knee.

What benefits of Spherox have been shown in studies?

Spherox has been shown to improve patients' symptoms and knee function in two studies in adults between 18 and 50 years of age. The main measure of effectiveness was the KOOS (knee injury and osteoarthritis outcome score), which is graded on a scale from 0 to 100 (where 0 means severest symptoms and 100 means no symptoms). The KOOS was self-measured by patients, who rated the severity of their symptoms such as pain, impact on daily living, sport and recreational activities, and quality of life.In the first study involving 100 adults, Spherox was compared with microfracture (a type of surgery used to treat defects in cartilage). The knee cartilage defects were between 1 and 4 cm2 in size. Data from this study showed that Spherox improved the outcome score by 22 points to 28 points until 5 years after treatment and was as effective as microfracture.The second study looked at 73 adults with large cartilage defects of the knee from 4 to 10 cm². All these patients received treatment with Spherox, as microfracture is not recommended to repair such large defects. In this study, patients' outcome scores with Spherox improved by 16 points in the first year and further improvements were seen up to three years after treatment and remained stable until five years after treatment.A third study looked at the treatment effect with Spherox in 105 adolescents aged between 15 and 17 years with cartilage defects of the knee joint. Overall, the results indicated that there was no major difference in terms of effectiveness between the adolescents included in this study and the young adults (from 18 to 34 years of age) who participated in the previous two studies.

What are the risks associated with Spherox?

The most common side effects with Spherox (which may affect up to 1 in 10 people) are bone marrow oedema (accumulation of fluid in the bone marrow), arthralgia (joint pain), joint effusion (accumulation of fluid in the knee),swelling of the joint and pain. For the full list of side effects of Spherox, see the package leaflet.Spherox must not be used in patients with primary generalised osteoarthritis or with advanced osteoarthritis of the knee (conditions causing swelling and pain in the joints) and in patients whose bones in the knee joint are still growing. It must also not be used in patients infected with hepatitis B, C and/or HIV.

Why is Spherox authorised in the EU?

Spherox has been shown to be effective at treating knee cartilage defects between 1 and 10 cm2 in size. Using chondrocyte spheroids that attach to the knee cartilage allows for less invasive surgery. The safety profile was considered acceptable; most side effects are expected to be due to the surgery. The European Medicines Agency therefore decided that Spherox's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Spherox?

The company that markets Spherox will ensure that all surgeons and other healthcare professionals handling or using the medicine receive training materials on how to use and store it, and that systems are in place to ensure that only healthcare professionals trained in using Spherox can use it, and that patients are tested to ensure they meet strictly defined clinical criteria. The training materials willSpherox (spheroids of human autologous matrix-associated chondrocytes)include guidance on how to safely collect and handle the cartilage sample from patients, implant Spherox as well as how to inform and follow up patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spherox have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Spherox are continuously monitored. Side effects reported with Spherox are carefully evaluated and any necessary action taken to protect patients.

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Spikevax

What is Spikevax and what is it used for?

Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.The originally authorised Spikevax contains elasomeran, a molecule called messenger RNA (mRNA) with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.Spikevax is also available as three adapted vaccines:• Spikevax bivalent Original/Omicron BA.1 contains elasomeran and an additional mRNA molecule, imelasomeran, with instructions for producing a protein from the Omicron BA.1 subvariant of SARS-CoV-2;• Spikevax bivalent Original/Omicron BA.4-5 contains elasomeran and an additional mRNA molecule, davesomeran, with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2• Spikevax XBB.1.5 contains andusomeran, an mRNA molecule with instructions for producing a protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2.Spikevax and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.

How is Spikevax used?

The originally authorised Spikevax is given in people from the age of 6 months as two injections, usually into the muscle of the upper arm, or the thigh in infants and young children, 28 days apart. A booster dose may be given to adults and children from the age of 6 years, at least 3 months after primary vaccination with Spikevax, or another mRNA vaccine or an adenoviral vector vaccine.1 Previously known as COVID-19 Vaccine ModernaSpikevax bivalent Original/Omicron BA.1 may be given as a single injection to adults and children from the age of 6 years, at least 3 months after primary vaccination or a booster dose with a COVID-19 vaccine.Both Spikevax bivalent Original/Omicron BA.4-5 and Spikevax XBB.1.5 are given as a single injection to adults and children aged 5 years and older, irrespective of their previous COVID-19 vaccination history. In children from 6 months to 4 years of age, they are given as a single injection in those who have completed a primary vaccination course or have had COVID-19 before, or as two injections 28 days apart in those who have not previously been vaccinated against COVID-19 or had COVID-19.An additional dose of Spikevax, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5 may be given to adults and children aged 6 months and older with a severely weakened immune system.The vaccines should be used according to official recommendations, issued at national level, by public health bodies.For more information about using Spikevax, including information about the adapted vaccines and doses for different age groups, see the package leaflet or consult a healthcare professional.

How does Spikevax work?

Spikevax works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body's cells and which can differ between variants of the virus.When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person's immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.If, later on, the person comes into contact with SARS-CoV-2, their immune system will recognise it and be ready to defend the body against it.After vaccination, the mRNA from the vaccine is broken down and removed from the body.Adapted vaccines work in the same way as the original vaccine and are expected to maintain protection against the virus as they contain mRNA more closely matching circulating variants of the virus.

What benefits of Spikevax have been shown in studies?

A very large clinical trial showed that Spikevax, given as a two-dose regimen, was effective at preventing COVID-19 in people from 18 years of age. The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection. The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1% efficacy in the trial. The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.19 mRNA Vaccine (nucleoside modified))Another study showed that an additional dose of Spikevax increased the ability to produce antibodies against SARS-CoV-2 in organ transplant patients with severely weakened immune systems.The effects of Spikevax were also investigated in a study involving over 3,000 children aged 12 to 17 years. The study showed that Spikevax produced a comparable immune response in 12- to 17-yearolds to that seen in young adults (aged 18 to 25 years), as measured by the level of antibodies against SARS-CoV-2. In addition, none of the 2,163 children who received the vaccine developed COVID-19, compared with four of 1,073 children given a dummy injection. These results allowed to conclude that the efficacy of Spikevax in children 12 to 17 years old is similar to that in adults.An additional study involving three groups of children aged 6 months to under 2 years, 2 to 5 years and 6 to 11 years showed that Spikevax produced a comparable immune response in these age groups to that seen in young adults (aged 18 to 25 years), as measured by the level of antibodies against SARS-CoV-2. These results indicate that the efficacy of Spikevax in children 6 months to 11 years old is similar to that in adults.Additional data showed that subsequent doses, including boosters, lead to a rise in levels of antibodies against SARS-CoV-2.Based on available data, vaccines adapted specifically to target circulating strains of the virus are expected to elicit a strong immune response against these strains.

Can children be vaccinated with Spikevax?

Originally authorised Spikevax, Spikevax bivalent Original/Omicron BA.4-5 and Spikevax XBB.1.5 are authorised for adults and children from 6 months of age.Spikevax bivalent Original/Omicron BA.1 is authorised for adults and children from 6 years of age.

Can immunocompromised people be vaccinated with Spikevax?

Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.Severely immunocompromised people may be given an additional dose of Spikevax as part of their primary vaccination.

Can pregnant or breast-feeding women be vaccinated with Spikevax?

Spikevax can be used during pregnancy.A large amount of data from pregnant women vaccinated with Spikevax during the second or third trimester of their pregnancy has been analysed and showed no increase in pregnancy complications. Although data in women in the first trimester of pregnancy are more limited, no increased risk of miscarriage was seen.Spikevax can be used during breast-feeding. Data from women who were breast-feeding after vaccination have not shown a risk of adverse effects in breast-fed babies.No data are currently available regarding the use of the adapted vaccines in pregnant or breast-feeding women. However, based on the similarity with the originally authorised Spikevax, including a comparable safety profile, the adapted vaccines can be used during pregnancy and breast-feeding.

Can people with allergies be vaccinated with Spikevax?

People who already know they have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.Allergic reactions (hypersensitivity) have been seen in people receiving the vaccine. A very small number of cases of anaphylaxis (severe allergic reaction) have occurred. Therefore, as for all vaccines, Spikevax, including the adapted vaccines, should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions. People who have a severe allergic reaction when they are given a dose of Spikevax or its adapted vaccines should not receive subsequent doses.

How well does Spikevax work for people of different ethnicities and genders?

The main clinical trials for Spikevax included people of different ethnicities and genders. The high efficacy was maintained across genders and ethnic groups.

What are the risks associated with Spikevax?

For the full list of side effects and restrictions with Spikevax, see the package leaflet.The most common side effects with Spikevax are usually mild or moderate and get better within a few days after vaccination. These include redness, pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea (feeling sick) and vomiting. They may affect more than 1 in 10 people. In infants under 3 years of age, irritability, crying, sleepiness and loss of appetite are also very common side effects (affecting more than 1 in 10 infants).Hives and rash at the injection site, sometimes occurring more than a week after injection, rash affecting areas other than the injection site and diarrhoea may affect less than 1 in 10 people. Itching at the injection site, dizziness and abdominal pain may affect less than 1 in 100 people. Swelling of the face, which may affect people who had facial cosmetic injections in the past, weakness in muscles on one side of the face (acute peripheral facial paralysis or palsy), paraesthesia (unusual feeling in the skin, such as tingling or a crawling feeling) and hypoaesthesia (reduced sensation to touch, pain and temperature) may affect less than 1 in 1,000 people.Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) may occur in up to 1 in 10,000 people.A very small number of cases of erythema multiforme (red patches on the skin with a dark red centre and paler red rings) have occurred. Allergic reactions have also occurred in people receiving the vaccine, including a very small number of cases of severe allergic reactions (anaphylaxis).The safety of the adapted vaccines is comparable to that of the originally authorised Spikevax vaccine.

Why is Spikevax authorised in the EU?

Data have shown that originally authorised Spikevax and its adapted vaccines cause the production of antibodies against SARS-CoV-2 that can protect against COVID-19. The main trials showed that the originally authorised vaccine has a high efficacy in all age groups. Most side effects are mild to moderate in severity and are gone within a few days.The European Medicines Agency therefore decided that the benefits of Spikevax, including its adapted vaccines, are greater than its risks, and it can be authorised for use in the EU.Spikevax was originally given 'conditional authorisation' because there was more evidence to come about the vaccine. The company has provided comprehensive information, including data regarding its safety, efficacy, and how well Spikevax prevents severe disease. In addition, the company has completed all requested studies on the pharmaceutical quality of the vaccine. As a result, the conditional authorisation has been switched to a standard one.

What measures are being taken to ensure the safe and effective use of Spikevax?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spikevax and its adapted vaccines have been included in the summary of product characteristics and the package leaflet.A risk management plan (RMP) is also in place and contains important information about the vaccine's safety, how to collect further information and how to minimise any potential risks.Safety measures for Spikevax and its adapted vaccines are implemented in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets Spikevax will provide regular safety reports.As for all medicines, data on the use of Spikevax and its adapted vaccines are continuously monitored.Suspected side effects are carefully evaluated and any necessary action taken to protect patients.

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Spinraza

What is Spinraza and what is it used for?

Spinraza is a medicine used to treat 5q spinal muscular atrophy (SMA), a genetic disease that causes weakness and wasting of the muscles including the lung muscles. The disease is linked to a defect on chromosome 5q and symptoms usually start shortly after birth.Because the number of patients with SMA is low, the disease is considered 'rare', and Spinraza was designated an 'orphan medicine' (a medicine used in rare diseases) on 2 April 2012.Spinraza contains the active substance nusinersen.

How is Spinraza used?

Spinraza can only be obtained with a prescription and treatment should be started by a doctor with experience in the treatment of SMA.The medicine is available as a solution for injection in 12 mg vials. It is given by intrathecal injection (into the lower back, directly into the spine) by a doctor or nurse experienced in carrying out this procedure. The patient may need to be sedated (given a medicine to calm them) before they are given Spinraza.The recommended dose is 12 mg (one vial), given as soon as possible after the patient has been diagnosed with SMA. The first dose should be followed by 3 more doses after 2, 4, and 9 weeks and then one dose every 4 months thereafter. Treatment should be continued for as long as the patient benefits from it. For further information, see the package leaflet.

How does Spinraza work?

Patients with SMA lack a protein called 'survival motor neuron' (SMN) protein, which is essential for motor neurons (nerve cells from the spinal cord that control muscle movements) to survive and function normally. The SMN protein is made from two genes, SMN1 and SMN2. Patients with SMA lack the SMN1 gene but have the SMN2 gene, which mostly produces a short SMN protein that does not work as well as a full-length protein.Spinraza is a synthetic anti-sense oligonucleotide (a type of genetic material) that enables the SMN2 gene to produce full length protein, which is able to work normally. This replaces the missing protein, thereby relieving the symptoms of the disease.

What benefits of Spinraza have been shown in studies?

One main study, involving 121 babies (of an average age of 7 months) with SMA, showed that Spinraza is effective in improving movement when compared with placebo (sham injection).After one year of treatment, 51% of babies receiving Spinraza (37 out of 73) showed progress in developing head control, rolling, sitting, crawling, standing and walking, whereas no similar progress was seen in any of the babies who received placebo. In addition, most babies treated with Spinraza survived for longer and needed breathing support later than those given placebo.Another study assessed Spinraza's effectiveness in children whose SMA was less severe and diagnosed at a later stage (average age of 3 years). After 15 months of treatment, 57% of children receiving Spinraza showed improvement in movement compared with 26% of children on placebo.

What are the risks associated with Spinraza?

The most common side effects with Spinraza (which may affect more than 1 in 10 people) are headache, back pain and vomiting. These side effects are thought to be caused by the injections into the spine used to give the medicine. In babies some side effects could not be assessed, as they could not communicate them.For the full list of all side effects and restrictions with Spinraza, see the package leaflet.

Why is Spinraza approved?

In its assessment, the European Medicines Agency recognised the serious nature of the disease and the urgent need for effective treatments.Spinraza has been shown to lead to clinically meaningful improvements in young children with varying degrees of disease severity. Although the medicine was not tested in patients with the most severe and the mildest forms of SMA, it is expected to provide similar benefits to these patients.Side effects were considered manageable, with most side effects related to the way the medicine is given.The Agency therefore decided that Spinraza's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Spinraza?

The company that markets Spinraza will complete ongoing studies of the long-term safety and effectiveness of the medicine in patients who are showing symptoms of SMA and patients not yet showing symptoms.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spinraza have also been included in the summary of product characteristics and the package leaflet.

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Spravato

What is Spravato and what is it used for?

Spravato is a medicine used to treat adults with major depression that is resistant to treatment. It is used in combination with an SSRI or SNRI medicine (other antidepressants) when at least two other treatments have failed.Spravato contains the active substance esketamine.

How is Spravato used?

Spravato is available as a nasal spray to be used by the patient in a clinic or doctor's office, under the direct supervision of a healthcare professional.The recommended starting dose is one or two sprays in each nostril (depending on the patient's age) on the first day. This is followed by 1, 2 or 3 sprays in each nostril twice a week for 4 weeks. Afterwards, if the patient's depression improves, Spravato should be used once a week for the next 4 weeks and then once every 1 or 2 weeks for at least 6 months.Because Spravato can increase blood pressure, patients' blood pressure should be measured before and after using Spravato. Patients with serious respiratory or heart problems should only use Spravato where facilities for resuscitating patients are immediately available.Spravato can only be obtained with a prescription and the decision to start treatment should be taken by a psychiatrist. For more information about using Spravato, see the package leaflet or contact your doctor or pharmacist.

How does Spravato work?

The active substance in Spravato, esketamine, is an antidepressant. It acts on receptors (targets) in the brain for a substance called NMDA. NMDA regulates the transmission of signals between cells in brain areas involved in the regulation of mood. By acting on these NMDA receptors, esketamine can help improve the symptoms of depression.

What benefits of Spravato have been shown in studies?

Studies in around 1,800 patients have shown that Spravato taken with an SSRI or SNRI relieves symptoms of treatment-resistant depression as measured using a standard scoring system known as MADRS.In a 4-week study, MADRS symptoms scores improved by 3.5 points more in patients treated with Spravato (plus an SSRI or SNRI) than in those treated with placebo (also with an SSRI or SNRI), a difference that is considered clinically relevant. Similar improvements were achieved in two other short-term studies, although the results were not as robust. The results of the three studies taken together convincingly showed that, overall, Spravato was more effective than placebo.In a fourth long-term study, Spravato was shown to be effective at preventing relapses of depression.The proportion of patients given Spravato (plus an SSRI or SNRI) who relapsed during the study was 27%, compared with 45% in the placebo group (also given an SSRI or SNRI). A fifth study lasting around 1 year showed that the benefits of Spravato (plus an SSRI or SNRI) were maintained longterm.

What are the risks associated with Spravato?

The most common side effects with Spravato (which may affect up to 3 in 10 people) are dizziness, nausea (feeling sick), dissociation (feeling of being disconnected from physical surroundings and emotions), headache, sleepiness, vertigo (a spinning sensation), dysgeusia (taste disturbances), hypoaesthesia (reduced sense of touch) and vomiting. For the full list of side effects of Spravato, see the package leaflet.Spravato must not be used in patients with weaknesses in blood vessel walls that might rupture if blood pressure goes up, patients who have had bleeding in the brain and patients who recently had a heart attack. For the full list of restrictions, see the package leaflet.

Why is Spravato authorised in the EU?

Studies showed that Spravato, added to SSRI or SNRI antidepressants, improves symptoms of major depression that have not improved with other treatment, both in the short- and in the long-term.Furthermore, the safety of Spravato was considered acceptable and its side effects manageable.Because of risk of patients misusing this medicine or becoming addicted to it, Spravato will only be available under a special prescription and must be taken under direct supervision of a healthcare professional. The European Medicines Agency concluded that with these restrictions in place the benefits of Spravato are greater than its risks and that it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Spravato?

The company that markets Spravato will provide educational material for doctors and a guide for patients with important information about Spravato's side effects, its risks and how to use the medicine.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spravato have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Spravato are continuously monitored. Side effects reported with Spravato are carefully evaluated and any necessary action taken to protect patients.

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Sprycel

What is Sprycel and what is it used for?

Sprycel is a cancer medicine. It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):• chronic myeloid leukaemia (CML) in the 'chronic' phase in newly diagnosed patients who are 'Philadelphia chromosome positive' (Ph+). In CML, granulocytes (a type of white blood cell) start growing out of control. Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia.• CML in 'chronic', 'accelerated' and 'blast' phases. Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;• Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in 'lymphoid blast' CML. Sprycel is used when other treatments do not work or cause troublesome side effects.Sprycel is also used in children to treat:• newly diagnosed Ph+ CML in the 'chronic' phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;• newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).Sprycel contains the active substance dasatinib.

How is Sprycel used?

Sprycel can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of leukaemia.Sprycel is available as tablets (20, 50, 70, 80, 100 and 140 mg) and a powder to make up a suspension (10 mg/ml) to be taken by mouth. It is taken once a day, consistently either in the morning or in the evening. The doses for Sprycel tablets and suspension are not the same.The starting dose depends on the condition being treated and, for children, their body weight. The dose is then gradually increased until the disease is controlled well enough. In children with ALL whoare also receiving other cancer medicines, a fixed dose of Sprycel is used throughout their treatment. The doctor may reduce the dose or interrupt treatment if blood cell counts are too low or certain side effects occur. Treatment is stopped if the medicine no longer controls the condition or if the patient cannot take the medicine because of side effects.For more information about using Sprycel, see the package leaflet or contact your doctor or pharmacist.

How does Sprycel work?

The active substance in Sprycel, dasatinib, belongs to a group of medicines that block enzymes known as protein kinases. Dasatinib acts mainly by blocking the Bcr-Abl protein kinase. This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably. By blocking Bcr-Abl kinase, as well as other kinases, Sprycel helps to reduce the number of leukaemia cells.

What benefits of Sprycel have been shown in studies?

The five main studies of Sprycel in adults involved 515 patients, all of whom had received treatment with imatinib, which had not worked or had stopped working. None of these studies compared Sprycel with another medicine. Most of these studies assessed how well the leukaemia responded to treatment by measuring the levels of white cells and platelets in the blood, to see if they were returning to within normal levels, and by measuring the number of white blood cells that contained the Philadelphia chromosome, to see if it was decreasing.Two studies were in patients with chronic CML (198 and 36 patients), one was in accelerated CML (120 patients), one was in myeloid blast CML (80 patients), and one was in Ph+ ALL and lymphoid blast CML (81 patients).In the larger main study of patients with chronic phase CML, blood levels of platelets and white blood cells returned to within normal values in 90% of the patients. In patients with CML in other phases (accelerated, myeloid blast and lymphoid blast) and in ALL, around 25 to 33% of the patients had complete response. In addition, the number of white blood cells containing the Philadelphia chromosome was reduced in around 33 to 66% of treated patients in the five main studies.Two further studies compared the effects of Sprycel taken once or twice a day, one in 670 patients with chronic phase CML and the other in 611 patients with advanced phase CML or Ph+ ALL. Once- and twice-daily Sprycel had similar effectiveness, but the once-daily dose caused fewer side effects.A further study involving 519 patients compared Sprycel with imatinib in treating newly diagnosed Ph+ patients with chronic phase CML who had not received any previous treatment. Sprycel was more effective than imatinib: within one year, 77% of patients receiving Sprycel no longer had the Philadelphia chromosome in their blood cells, compared with 66% of patients receiving imatinib.Another main study looked at the effectiveness of Sprycel in 113 children with Ph+ chronic phase CML, including 29 patients who could not use imatinib or it had not worked, as well as 84 newly diagnosed children who had not been previously treated. A response was seen in around 90% of patients who could not use imatinib or it had not worked, and in 94% of newly diagnosed patients.In a study involving 106 children and adolescents with newly diagnosed Ph+ ALL, patients were treated with Sprycel and chemotherapy. The main measure of effectiveness was the proportion of patients who did not have an unwanted event within 3 years of treatment. Such events were: any sign of the disease in bone marrow, return of the disease anywhere in the body, a second cancer or death. Among patients treated with Sprycel and chemotherapy, 66% did not have an unwanted event. InSprycelcomparison, using results of previous studies, the figure was 49% in patients who had received chemotherapy alone and 59% in patients who had received imatinib and chemotherapy.

What are the risks associated with Sprycel?

The most common side effects with Sprycel (seen in more than 1 patient in 10) are infection, suppression of the bone marrow (decreasing numbers of blood cells), headache, haemorrhage (bleeding), pleural effusion (fluid around the lungs), dyspnoea (difficulty breathing), diarrhoea, vomiting, nausea (feeling sick), abdominal pain (belly ache), skin rash, musculoskeletal pain, tiredness, swelling in the legs and arms and in the face, fever. For the full list of side effects and restrictions with Sprycel, see the package leaflet.

Why is Sprycel authorised in the EU?

The European Medicines Agency decided that Sprycel's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sprycel?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sprycel have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sprycel are continuously monitored. Side effects reported with Sprycel are carefully evaluated and any necessary action taken to protect patients.

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Stalevo

What is Stalevo?

Stalevo is a medicine that contains three active substances: levodopa, carbidopa and entacapone. It is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa. All of the tablets contain 200 mg entacapone

What is Stalevo used for?

Stalevo is used to treat adults with Parkinson's disease. Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Stalevo is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having 'fluctuations' towards the end of the period between two doses of their medication. Fluctuations happen when the effects of the medication wear off and symptoms re-emerge. They are linked with a reduction in the effect of levodopa, when the patient experiences sudden switches between being 'on' and able to move, and being 'off' and having difficulty moving about. Stalevo is used when these fluctuations cannot be treated with the standard combination alone.The medicine can only be obtained with a prescription

How is Stalevo used?

Each Stalevo tablet contains one complete dose of levodopa, in seven strengths, with corresponding amounts of carbidopa and entacapone to improve its effectiveness. The strength of Stalevo that thepatient should use is based on the amount of levodopa they need to control their symptoms. See the Summary of Product Characteristics (also part of the EPAR) for full instructions on how patients should be switched to Stalevo, and on how the dose is adjusted during treatment.The maximum daily dose of Stalevo is 10 tablets, except for the tablets containing 200 mg levodopa and 50 mg carbidopa, for which the maximum daily dose is seven tablets. Stalevo tablets should be taken whole, with or without food. They should be used with caution in patients with mild to moderate problems with their liver or severe problems with their kidneys. They should not be used in patients with severe liver problems.

How does Stalevo work?

In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. All of the active substances in Stalevo work to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.Levodopa is converted into dopamine in the brain. Both carbidopa and entacapone block some of the enzymes that are involved in the breakdown of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, and entacapone blocks the enzyme catechol-O-methyl transferase (COMT). As a result, levodopa remains active for longer. This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.Entacapone has been authorised in the European Union (EU) as Comtess/Comtan since 1998. The useof combinations of levodopa and carbidopa is well established, having being in use since the mid-1970s. Having all three substances in the same tablet can lower the number of tablets the patients have to take and help them stick to treatment.

How has Stalevo been studied?

The company used some of the data from Comtess/Comtan to support the use of Stalevo and presented data from the published literature for levodopa and carbidopa.The company carried out 'bioequivalence' studies to show that taking Stalevo produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.

What benefit has Stalevo shown during the studies?

The studies showed that Stalevo is bioequivalent to the separate tablets.

What is the risk associated with Stalevo?

The most common side effects with Stalevo (seen in more than 1 patient in 10) are dyskinesia(uncontrollable movements), aggravated Parkinsonism (worsening of Parkinson's disease), nausea (feeling sick) and harmless urine discoloration. For the full list of all side effects reported with Stalevo, see the package leaflet.Stalevo should not be used in people who may be hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients. Stalevo must not be used in patients with:severe liver disease;narrow-angle glaucoma (increased pressure within the eye);phaeochromocytoma (a tumour of the adrenal gland);a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).Stalevo must not be used together with other medicines that belong to the group 'monoamine oxidase inhibitors' (a type of antidepressant). See the summary of product characteristics (also part of the EPAR) for full details.

Why has Stalevo been approved?

The CHMP decided that Stalevo's benefits are greater than its risks for the treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor treatment. The Committee recommended that Stalevo be given marketing authorisation.

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Stayveer

What is Stayveer and what is it used for?

Stayveer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms. PAH is abnormally high blood pressure in the arteries of the lungs. The 'class' reflects the severity of the disease: 'class III' PAH involves marked limitation of physical activity. The PAH can be:• primary (with no identified cause or inherited);• caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);• caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.Some improvement with Stayveer can also occur in patients with class II PAH. 'Class II' involves slight limitation of physical activity.Stayveer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes). Stayveer is given to reduce the number of new digital ulcers.Stayveer contains the active substance bosentan. This medicine is the same as Tracleer, which is already authorised in the EU. The company that makes Tracleer has agreed that its scientific data can be used for Stayveer ('informed consent').

How is Stayveer used?

Stayveer can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.Stayveer is available as film-coated tablets (62.5 mg and 125 mg). It is taken morning and evening. In adults, the starting dose is 62.5 mg twice a day for four weeks, which is increased to the usual dose of 125 mg twice a day.An agency of the EuropeanFor more information about using Stayveer, see the package leaflet or contact your doctor or pharmacist.

How does Stayveer work?

The active substance in Stayveer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow. Stayveer therefore prevents blood vessels from narrowing.In PAH, severe narrowing of the blood vessels in the lungs increases blood pressure and reduces the amount of blood entering the lungs. By expanding these blood vessels, pressure is reduced and symptoms are improved.In patients with systemic sclerosis and digital ulcer disease, there is narrowing of the blood vessels of the fingers and toes leading to ulcers. Bosentan improves blood circulation and thereby, prevents the development of new digital ulcers.

What benefits of Stayveer have been shown in studies?

Treatment of PAHIn PAH, Stayveer added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.This is based on two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma. In the larger study patients were able to walk 44 metres further. Similar results were seen in a study in 54 adults with class III PAH that was associated with congenital heart defects. There were too few patients with class IV disease to support the use of the medicine in this group.In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Stayveer and placebo groups. However, Stayveer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.Treatment of systemic sclerosis with digital ulcersStayveer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults. In the first study, patients taking Stayveer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo. Similar results were seen in the second study after 24 weeks. The second study which also looked at the effect of Stayveer on digital ulcer healing in 190 patients did not find any effect.

What are the risks associated with Stayveer?

The most common side effects with Stayveer (which may affect more than 1 in 10 people) are headache, fluid retention, anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body) and abnormal results of blood tests to check the liver. For the full list of side effects of Stayveer, see the package leaflet.Stayveer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin (a medicine that acts on the immune system). For the full list of restrictions, see the package leaflet.

Why is Stayveer authorised in the EU?

The European Medicines Agency decided that Stayveer's benefits are greater than its risks and recommended that it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Stayveer?

The company that makes Stayveer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stayveer have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Stayveer are continuously monitored. Side effects reported with Stayveer are carefully evaluated and any necessary action taken to protect patients.

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Steglatro

What is Steglatro and what is it used for?

Steglatro is a medicine used to treat adults with type 2 diabetes together with diet and exercise.Steglatro can be used in combination with other diabetes medicines or on its own in patients who cannot take metformin.Steglatro contains the active substance ertugliflozin.

How is Steglatro used?

Steglatro is available as tablets. The dose depends on how well the patient's glucose (sugar) levels are controlled.The doctor will check how well the patient's kidneys are working before treatment and regularly during treatment. The dose of Steglatro may be reduced or it may be stopped if the kidneys are not working well enough. Treatment will not be started if the kidney function is too poor.For more information about using Steglatro, see the package leaflet or contact your doctor or pharmacist. Steglatro can only be obtained with a prescription.

How does Steglatro work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The result is a high level of glucose in the blood.The active substance in Steglatro, ertugliflozin, helps to lower glucose in the blood by making the patient pass out glucose in the urine. It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.

What benefits of Steglatro have been shown in studies?

Seven main studies in around 4,800 patients with type 2 diabetes have shown that ertugliflozin helps lower glucose levels on its own and in combination with other diabetes medicine. The studies lookedmainly at effects on levels of HbA1c (a measure of blood glucose) after six months or one year of treatment. At the start of the studies, patients' HbA1c level was above 7 percentage points. The results were as follows:• A study of ertugliflozin on its own, showed that levels of HbA1c fell by between 0.8 points and 1 point in patients who took the medicine compared with a rise of 0.2 points in patients receiving placebo (a dummy treatment).• A second study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with a reduction of 0.03 points when placebo was added to metformin.• A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about as effective as a combination of metformin with another diabetes medicine, glimepiride. HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride. A lower dose of ertugliflozin 5 mg was less effective.• A fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as adding sitagliptin (another diabetes medicine), with HbA1c levels falling by around 1 point with both treatments. HbA1c levels fell by a further 0.5 points when both medicines were added to metformin.• A fifth study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo. HbA1c levels fell by between 0.8 and 0.9 points when ertugliflozin was added, compared with a fall of 0.1 with placebo.• A sixth study found that adding the combination of ertugliflozin and sitagliptin to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.• A seventh study showed that ertugliflozin was not more effective than placebo in patients with moderate kidney impairment. The data from this study showed that the effect of ertugliflozin reduces when the kidneys do not work properly.In addition to lowering glucose levels, studies showed that ertugliflozin helped reduce patients' bodyweight and risk of heart failure.

What are the risks associated with Steglatro?

The most common side effects with Steglatro (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system and urinary tract infections.For the full list of side effects and restrictions with Steglatro, see the package leaflet.

Why is Steglatro authorised in the EU?

The European Medicines Agency concluded that Steglatro's benefits are greater than its risks and it can be authorised for use in the EU.The Agency considered that Steglatro can treat patients with type 2 diabetes on its own and in combination with other diabetes medicines. In addition, Steglatro can help some patients lose weight and may reduce the risk of heart failure. Because ertugliflozin has less effect on blood sugar in patients whose kidney function is reduced, combining Steglatro with other medicines that lower blood sugar may need to be considered in such patients.

What measures are being taken to ensure the safe and effective use of Steglatro?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Steglatro have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Steglatro is continuously monitored. Side effects reported with Steglatro are carefully evaluated and any necessary action taken to protect patients.

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Steglujan

What is Steglujan and what is it used for?

Steglujan is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following patients:• patients whose blood glucose levels are not satisfactorily controlled with the diabetes medicines metformin and/or a sulphonylurea, in combination with either ertugliflozin or sitagliptin;• patients who are already taking ertugliflozin and sitagliptin as separate tablets.Steglujan contains the active substances ertugliflozin and sitagliptin.

How is Steglujan used?

Steglujan is available as tablets in 2 strengths of ertugliflozin and sitagliptin (5 mg/100 mg and 15 mg/100 mg) and can only be obtained with a prescription.The recommended starting dose is one 5 mg/100 mg tablet taken once a day. In patients whose blood sugar needs further control, the dose can be increased to one 15 mg/100 mg tablet once a day.For more information about using Steglujan, see the package leaflet or contact your doctor or pharmacist.

How does Steglujan work?

Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The result is a high level of glucose in the blood. The two active substances in Steglujan work in different ways to lower glucose levels:Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine. It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.Sitagliptin blocks the breakdown of incretin hormones in the body. These hormones stimulate the pancreas to produce insulin. Prolonging the action of incretin hormones makes the pancreas produce more insulin when blood glucose levels are high. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.Together, these actions reduce blood glucose levels and help to control type 2 diabetes.

What benefits of Steglujan have been shown in studies?

Three main studies, involving 1,987 patients showed that Steglujan was effective at lowering blood glucose levels in patients with type 2 diabetes, as measured by the decrease in blood levels of HbA1c (a measure of blood glucose) after 6 months of treatment. At the start of the studies, patients' HbA1c was above 7.0%. In addition, the results indicated that treatment with Steglujan was associated with a beneficial reduction in body weight.The first study, in patients who were all taking metformin, compared the combination of ertugliflozin and sitagliptin with ertugliflozin or sitagliptin on their own. Treatment with the combination of ertugliflozin and sitagliptin lowered HbA1c levels by up to 1.5 percentage points, compared with reductions of up to 1.1 for ertugliflozin and for sitagliptin on their own.The second study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo (a dummy treatment). HbA1c levels fell by between 0.8 and 0.9 points, compared with a fall of 0.1 with placebo.The third study compared Steglujan with placebo in patients who were not taking other diabetes medicines and in whom diet and exercise were not enough to control their blood sugar levels. This study found that adding Steglujan to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.

What are the risks associated with Steglujan?

The most common side effects with Steglujan (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system.For the full list of side effects and restrictions with Steglujan, see the package leaflet.

Why is Steglujan authorised in the EU?

Steglujan was shown to be effective at controlling blood glucose levels. Treatment with Steglujan also led to weight loss, which is considered beneficial in patients with diabetes. The benefits of Steglujan were lower in patients with kidney problems. Regarding safety, this was considered in line with that of other medicines of the same class.The European Medicines Agency decided that Steglujan's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Steglujan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Steglujan have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Steglujan is continuously monitored. Side effects reported with Steglujan are carefully evaluated and any necessary action taken to protect patients.

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Stelara

What is Stelara and what is it used for?

Stelara is a medicine used to treat:• moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine called psoralen, before being exposed to ultraviolet light;• active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs). Stelara may be used alone or combined with methotrexate (a DMARD);• moderately to severely active Crohn's disease (a disease-causing inflammation of the gut) in adults whose condition has not improved enough with other treatments for Crohn's disease or who cannot receive such treatments;• moderately to severely active ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments.Stelara contains the active substance ustekinumab.

How is Stelara used?

Stelara can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Stelara is used for.In plaque psoriasis and psoriatic arthritis, Stelara is injected under the skin. For adults the usual dose is 45 mg, whereas in children with plaque psoriasis the dose depends on their bodyweight. The dose in patients weighing over 100 kg is 90 mg for psoriasis, and this dose may also be considered for psoriatic arthritis. The first injection is followed by a further injection 4 weeks later, and then an injection every 12 weeks.In Crohn's disease and ulcerative colitis, treatment is started with Stelara infusion (drip) into a vein over at least 1 hour. The dose depends on the patient's bodyweight. Eight weeks after the first infusion, a dose of 90 mg is injected under the skin. Patients then continue with Stelara injected under the skin every 8 or 12 weeks depending on how well the treatment is working.Patients or their caregivers may inject Stelara under the skin once they have been trained, if their doctor thinks that this is appropriate. For more information about using Stelara, see the package leaflet or contact your doctor or pharmacist.

How does Stelara work?

The active substance in Stelara, ustekinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target in the body. Ustekinumab attaches to 2 messenger molecules in the immune system called interleukin 12 and interleukin 23. Both are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.

What benefits of Stelara have been shown in studies?

Plaque psoriasisIn the treatment of moderate to severe plaque psoriasis, Stelara was more effective than placebo (a dummy treatment) in 2 main studies involving a total of 1,996 adult patients. In over half of these patients, other treatments for psoriasis had not worked, were not tolerated or could not be taken by the patients. The main measure of effectiveness was the number of patients whose symptom score improved by 75% or more after 12 weeks. Taking the results of the 2 main studies in adults together, symptoms improved in around 69% of the patients receiving Stelara after 12 weeks, compared with around 3% of the patients receiving placebo.Longer-term results from these studies showed that with continuous treatment for 5 years, improvement of symptoms with Stelara is maintained. A study comparing Stelara with etanercept (another medicine used for psoriasis) found that Stelara is more effective than etanercept after 12 weeks of treatment.Two studies were carried out in children with moderate to severe plaque psoriasis. The main measure of effectiveness for both studies was the number of patients whose symptom score improved after treatment for 12 weeks. The first study involved 110 children aged between 12 and 18 years. The children received placebo or Stelara. Around 69% of children who received Stelara achieved a score of cleared or minimal, compared with 5% of patients receiving placebo. The second study involved 44 children aged between 6 and 11 years. All children received Stelara and this was not compared to any other treatment. Around 77% of children achieved a score of cleared or minimal.Psoriatic arthritisIn the treatment of active psoriatic arthritis, Stelara was compared with placebo in 2 main studies involving a total of 927 adult patients whose condition was not controlled well enough with previous treatments. In both studies, the main measure of effectiveness was the number of patients whose symptom score improved after 24 weeks. In the first study, symptom score improved in around 42% of those given Stelara 45 mg and 50% of those given 90 mg, compared with around 23% of those given placebo. In the second study, symptom score improved in around 44% of those given either dose of Stelara, compared with around 20% of those given placebo.Crohn's diseaseIn the treatment of Crohn's disease, Stelara (given by infusion) was compared with placebo in 2 main studies involving 1,369 patients with moderately to severely active disease. The main measure of effectiveness was the number of patients whose symptom score improved 6 weeks after the infusion. In the first study, symptom score improved in around 34% patients who received Stelara compared with 21% of patients receiving placebo. In the second study the figures were 56% for Stelara and 29% for placebo.Some patients from the 2 main studies went on to receive Stelara (injected under the skin) every 8 or 12 weeks, or placebo. After 44 weeks of starting treatment by injection under the skin, 53% of patients on Stelara every 8 weeks and 49% of patients on Stelara every 12 weeks had a significant reduction in symptoms of Crohn's disease, compared with 36% of patients on placebo.Ulcerative colitisIn the treatment of ulcerative colitis, Stelara (given by infusion) was compared with placebo in 2 main studies. The first study involved 961 patients with moderately to severely active disease. The main measure of effectiveness was the number of patients whose symptoms were gone or almost gone 8 weeks after the infusion. Symptoms were gone or almost gone in 16% of patients who received Stelara compared with 5% of patients receiving placebo.In the second study, a total of 523 patients from the first study whose symptoms had improved with Stelara went on to receive the medicine (injected under the skin) every 8 or 12 weeks, or placebo. After 44 weeks of starting treatment by injection under the skin, symptoms of ulcerative colitis were gone or almost gone in 44% of patients on Stelara every 8 weeks and 38% of patients on Stelara every 12 weeks, compared with 24% of patients on placebo.

What are the risks associated with Stelara?

The most common side effects with Stelara (seen in more than 1 in 20 during clinical trials) are headache and nasopharyngitis (inflammation of the nose and throat). The most serious side effect reported with Stelara is serious hypersensitivity (allergic reaction). For the full list of side effects of Stelara, see the package leaflet.Stelara must not be used in patients who have an active infection that the doctor considers important.For the full list of restrictions, see the package leaflet.

Why is Stelara approved?

The European Medicines Agency decided that Stelara's benefits are greater than its risks and it can be authorised for use in the EU.The Agency considered that studies had shown that Stelara was effective in the treatment of adults and children over 6 years of age with moderate to severe plaque psoriasis in whom other treatments had not worked or could not be used.For adults with psoriatic arthritis whose condition had not improved enough with DMARDs, the Agency noted that limited treatments were available and considered that Stelara would be of benefit in these patients.In Crohn's disease, the effects of Stelara in reducing symptoms in patients in whom other treatments had not worked or could not be used were considered important, also given the unmet medical need of these patients. The side effects of the medicine were considered manageable.In ulcerative colitis, studies showed that Stelara was effective in treatment of patients in whom other treatments had not worked or could not be used. The side effects were as expected for this medicine.

What measures are being taken to ensure the safe and effective use of Stelara?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stelara have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Stelara are continuously monitored. Side effects reported with Stelara are carefully evaluated and any necessary action taken to protect patients.

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Stimufend

What is Stimufend and what is it used for?

Stimufend is a medicine used in patients with cancer to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (neutropenia accompanied by fever).Stimufend is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions where large numbers of abnormal blood cells are produced, which can develop into leukaemia).Stimufend is a 'biosimilar medicine'. This means that Stimufend is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Stimufend is Neulasta. For more information on biosimilar medicines, see here.Stimufend contains the active substance pegfilgrastim.

How is Stimufend used?

Stimufend can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.It is available as a prefilled syringe containing a solution for injection under the skin. Stimufend is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines). Patients can inject themselves if they have been trained appropriately.For more information about using Stimufend, see the package leaflet or contact your doctor or pharmacist.

How does Stimufend work?

The active substance in Stimufend, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim works by encouragingthe bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.In Stimufend, as in the reference medicine, filgrastim has been 'pegylated' (attached to a chemical called polyethylene glycol). This slows down the removal of filgrastim from the body, allowing the medicine to be given less often.

What benefits of Stimufend have been shown in studies?

Laboratory studies comparing Stimufend with Neulasta have shown that the active substance inStimufend is highly similar to that in Neulasta in terms of structure, purity and biological activity. Studies have also shown that giving Stimufend produces similar levels of the active substance in the body to giving Neulasta.Because Stimufend is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Stimufend.

What are the risks associated with Stimufend?

The safety of Stimufend has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.The most common side effect with Stimufend (which may affect more than 1 in 10 people) is pain in the bones. Pain in muscles is also common. For the full list of side effects and restrictions with Stimufend, see the package leaflet.

Why is Stimufend authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Stimufend has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.All these data were considered sufficient to conclude that Stimufend will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Neulasta, the benefits of Stimufend outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Stimufend?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stimufend have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Stimufend are continuously monitored. Suspected side effects reported with Stimufend are carefully evaluated and any necessary action taken to protect patients.

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Stivarga

What is Stivarga and what is it used for?

Stivarga is a cancer medicine that contains the active substance regorafenib. It is used on its own to treat the following cancers:• colorectal cancer (cancer of the bowel and rectum) that has spread to other parts of the body;• gastrointestinal stromal tumour (GIST, a cancer of the stomach and bowel) that has spread or cannot be surgically removed;• hepatocellular carcinoma (HCC, a cancer of the liver).Stivarga is used in patients who have already been treated with, or who cannot be given, other available treatments. For colorectal cancer, these include chemotherapy based on medicines called fluoropyrimidines and treatment with other cancer medicines known as anti-VEGF and anti-EGFR therapies. Patients with GIST should have tried treatment with imatinib and sunitinib and patients with HCC should have tried sorafenib before starting treatment with Stivarga.

How is Stivarga used?

Treatment with Stivarga must be prescribed by a doctor who is experienced in treating cancer. The medicine can only be obtained with a prescription.Stivarga is available as tablets (40 mg). It is taken in 4-week treatment cycles at a recommended starting dose of 160 mg (4 tablets) once every day for three weeks, followed by a week without taking the medicine. Doses should be taken at the same time each day with a light meal. Treatment shouldcontinue for as long as the patient benefits from treatment or until the side effects become too severe. Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects. For further information, see the package leaflet.

How does Stivarga work?

The active substance in Stivarga, regorafenib, is a 'protein kinase inhibitor'. This means that it blocks several enzymes that are important for the development of a blood supply to tumours and the growth and development of cancer cells. By blocking the action of these enzymes, Stivarga helps to stop the growth and spread of the cancer.

What benefits of Stivarga have been shown in studies?

Colorectal cancerIn a main study involving 760 patients with metastatic colorectal cancer which had progressed after standard therapy, Stivarga was compared with placebo (a dummy treatment) and the main measure of effectiveness was overall survival (the length of time that patients lived). All patients also received supportive care, including pain medicines and treatment for infections. The study showed that Stivarga improved survival, with treated patients living for 6.4 months on average, compared with 5 months for those given placebo.GISTIn another main study, Stivarga was compared with placebo in 199 patients with GIST that had spread or was inoperable and who were also given best supportive care. Supportive care included treatments like pain relief, antibiotics, and blood transfusions that help the patient but without treating the cancer. The study showed that Stivarga with supportive care was effective at prolonging the length of time patients lived without their disease getting worse. Patients treated with Stivarga lived on average for 4.8 months without their disease getting worse compared with 0.9 months for patients taking placebo and supportive care.HCCIn a main study involving 573 patients with HCC that had worsened after treatment with sorafenib, Stivarga was compared with placebo and the main measure of effectiveness was overall survival. All patients also received supportive care. The study showed that Stivarga increased the length of time that patients lived overall, with patients treated with Stivarga living for 10.6 months on average, compared with 7.8 months for those given placebo.

What are the risks associated with Stivarga?

The most common side effects with Stivarga (which may affect more than 3 in 10 people) are pain, weakness, tiredness, loss of appetite and eating less, hand-foot syndrome (rash and numbness affecting the palms and soles), diarrhoea, infection and hypertension (high blood pressure). The most serious side effects are severe liver injury, bleeding, gastrointestinal perforation (development of a hole in the wall of the gut) and infection.For the full list of all restrictions and side effects with Stivarga, see the package leaflet.Stivarga

Why is Stivarga approved?

The European Medicines Agency decided that Stivarga's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee noted that in colorectal cancer the benefits in terms of extending patient survival were modest, but considered that they outweighed the risks in patients for whom there are no other remaining treatment options. However, given the side effects, the CHMP considered it important to find ways to identify any subgroups of patients who are more likely to respond to Stivarga.With regard to GIST and HCC, the Committee noted that the outlook is poor for patients whose disease gets worse despite previous treatment. Stivarga had been shown to delay the worsening of the disease in these patients. For patients with HCC, this led to an improvement in the length of time patients lived. The side effects of Stivarga are manageable.

What measures are being taken to ensure the safe and effective use of Stivarga?

The company that markets Stivarga will carry out studies to look for ways of identifying patients who are more likely to respond to treatment.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stivarga have also been included in the summary of product characteristics and the package leaflet.

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Stocrin

What is Stocrin and what is it used for?

Stocrin is an antiviral medicine that is used together with other antiviral medicines to treat patients aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

How is Stocrin used?

Stocrin can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection. It is available as capsules, tablets and oral solution and must be given in combination with other antiviral medicines. It is recommended that Stocrin be taken on an empty stomach and without food, preferably at bedtime.The recommended dose of Stocrin for adults is 600 mg once a day. In patients aged 3 to 17 years, the dose depends on body weight. For patients who are unable to swallow the capsules or tablets, Stocrin can be given using the oral solution. The dose of Stocrin may need to be adjusted in patients taking certain other medicines at the same time.For full details, see the summary of product characteristics (also part of the EPAR).

How does Stocrin work?

The active substance in Stocrin, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected. By blocking this enzyme, Stocrin, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Stocrin does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

What benefits of Stocrin have been shown in studies?

Stocrin has shown benefit in controlling HIV infection in three main studies involving over 1,100 adults. In all of the studies, the main measure of effectiveness was the number of patients with undetectable levels of HIV-1 in their blood (viral loads) after 24 or 48 weeks of treatment:• in the first study, Stocrin in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine. 67% of the adults treated with Stocrin in combination with zidovudine and lamivudine had viral loads below 400 copies/ml after 48 weeks, compared with 54% of the patients treated with Stocrin and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;• the second study compared Stocrin in combination with nelfinavir and two other antiviral medicines with the same combination without Stocrin. The Stocrin combination was more effective than the combination without Stocrin: 70% and 30% of the patients, respectively, had viral loads below 500 copies/ml after 48 weeks;• the third study compared adding Stocrin or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection. More patients receiving Stocrin had viral loads below 400 copies/ml than those taking placebo after 24 weeksSimilar results were seen in a study in 57 children aged between 3 and 16 years, given Stocrin in combination with nelfinavir and other antiviral medicines.

What are the risks associated with Stocrin?

The most common side effect with Stocrin (seen in more than 1 patient in 10) is rash. Stocrin is also commonly associated with dizziness, headache, nausea (feeling sick) and tiredness. Taking Stocrin with food may lead to an increase in the frequency of side effects. For the full list of side effects reported with Stocrin, see the package leaflet.Stocrin must not be used in patients with severe liver disease. Stocrin can affect the electrical activity of the heart and so must also not be used in patients with heart problems such as changes in heart rhythm and activity, slow heart rate or heart failure or other conditions that can affect the heart's electrical activity, or who have close relatives that have died suddenly from a heart condition or were born with heart problems. Similarly, it must not be used in patients with altered levels of salts (electrolytes) such as potassium or magnesium in their blood.Stocrin must be avoided if patients are taking certain medicines because it can increase their side effects or reduce their effectiveness, or because the combination may increase effects on the heart. See the package leaflet for further details.

Why is Stocrin approved?

The European Medicines Agency decided that Stocrin's benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents, and children three years of age and older and recommended that it be approved for use in the EU. The Agency noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working. It also noted that there is little information on the benefits of treatment that includes a protease inhibitor in patients who have been treated with Stocrin in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.

What measures are being taken to ensure the safe and effective use of Stocrin?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stocrin have been included in the summary of product characteristics and the package leaflet.

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Strensiq

What is Strensiq and what is it used for?

Strensiq is a medicine used long-term to treat patients with hypophosphatasia that started in childhood. Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.Strensiq contains the active substance asfotase alfa.Hypophosphatasia is rare, and Strensiq was designated an 'orphan medicine' (a medicine used in rare diseases) on 3 December 2008. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu308594.

How is Strensiq used?

Strensiq can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing metabolic or bone disorders.The medicine is available as a solution for injection. It is given by injection under the skin either six times a week (in a dose of 1 mg per kilogram bodyweight) or three times a week (in a dose of 2 mg/kg). As the amount given depends on the patient's bodyweight, the doctor will need to adjust the dose as the patient's weight changes, particularly in growing children.For more information about using Strensiq, see the package leaflet or contact your doctor or pharmacist.

How does Strensiq work?

The enzyme 'tissue non-specific alkaline phosphatase' (ALP) plays a key role in creating and maintaining healthy bones, and managing calcium and phosphate in the body. Patients with hypophosphatasia cannot make enough working ALP, which leads to weak bones. Asfotase alfa, the active substance in Strensiq, is a version of the human ALP enzyme and serves as a replacement, thereby increasing levels of working ALP.

What benefits of Strensiq have been shown in studies?

Strensiq has been studied in one main study in 13 children between 6 and 12 years of age. Patients were given either 2 mg/kg or 3 mg/kg Strensiq three times a week for 24 weeks. The main measure of effectiveness of the medicine was the improvement in x-ray appearance of the wrists and knee joints before and after treatment with Strensiq. X-rays of children given Strensiq were also compared with similar x-rays available from 16 children who had not received Strensiq ('historical controls'). The study also looked at other measures of effectiveness such as growth in height. This study showed that children given Strensiq had an improvement in their joint structure as demonstrated by x-rays and most of them seemed to gain in height. In the historical controls, most children did not experience similar improvements in their joints or gain in height over a comparable period of time. Additional data from an extension of this study in children aged 13 to 18 years confirmed the initial results.The effectiveness of Strensiq was also generally supported by several additional small studies. Some of the studies also looked at the dose of 1 mg/kg Strensiq given six times a week.

What are the risks associated with Strensiq?

The most common side effects with Strensiq (which may affect more than 1 in 10 people) are headache, erythema (reddening of the skin), pain in arms and legs, fever, irritability, injection site reactions (such as pain, rash and itching) and contusion (bruising). For the full list of side effects and restrictions with Strensiq, see the package leaflet.

Why is Strensiq authorised in the EU?

The European Medicines Agency decided that Strensiq's benefits are greater than its risks and it be authorised for use in the EU.The Agency noted that hypophosphatasia is a serious and life-threatening disease for which no treatment is authorised. Although the main study was small and did not directly compare Strensiq with another treatment or with untreated patients, the Agency considered that the improvement seen in the bones and the apparent growth was relevant. Given that hypophosphatasia is an extremely rare disease, data in this population will likely remain limited. Regarding safety, injection site reactions and other side effects were considered manageable with the recommendations in place.Strensiq has been authorised under 'exceptional circumstances'. This is because it has not been possible to obtain complete information about Strensiq due to the rarity of the disease. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Strensiq?

Since Strensiq has been authorised under exceptional circumstances, the company that markets Strensiq will set up a registry of patients with hypophosphatasia to collect information on the disease and on the long-term safety and effectiveness of Strensiq.

What measures are being taken to ensure the safe and effective use of Strensiq?

The company that markets Strensiq will provide patients and carers with educational materials to ensure that the medicine is used correctly and to minimise the risk of medication errors. This materialwill include a self-injection guide for patients, as well as an injection guide for parents or caregivers of children with the condition.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Strensiq have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Strensiq is continuously monitored. Side effects reported with Strensiq are carefully evaluated and any necessary action taken to protect patients.

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Striascan

What is Striascan and what is it used for?

Striascan is a diagnostic medicine. It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):• movement disorders such as those in Parkinson's disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles. Because tremor can also occur in 'essential tremor' (tremor whose cause is unknown), Striascan can help distinguish between essential tremor and diseases related to Parkinson's disease;• dementia (loss of intellectual function). Striascan is used to help distinguish between a type of dementia known as 'dementia with Lewy bodies' and Alzheimer's disease.Striascan contains the active substance ioflupane (123I) and is a 'generic medicine'. This means that Striascan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called DaTSCAN. For more information on generic medicines, see the question-and-answer document here.

How is Striascan used?

Striascan can only be obtained with a prescription and should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia. Striascan is only handled and given by people who have experience in the safe handling of radioactive materials.Striascan is given by slow injection lasting at least 15 to 20 seconds into an arm vein. A scan is taken 3 to 6 hours after the injection. Between 1 to 4 hours before receiving Striascan, patients must also take another medicine, such as iodine tablets, to prevent the radioactive iodine in Striascan from getting into the thyroid gland.Resuscitation equipment should be available before Striascan is given, in case the patient has an allergic reaction.SendFor more information about using Striascan, see the package leaflet or contact your doctor or pharmacist.

How does Striascan work?

The active substance in Striascan, ioflupane (123I), is a radiopharmaceutical. It contains a substance called ioflupane, which is labelled with 123I (iodine-123), a radioactive form of iodine. Ioflupane attaches specifically to structures on nerve cell endings that are responsible for the transport of dopamine.When Striascan is injected, ioflupane (123I) is distributed by the blood and builds up in the striatum, where it attaches to the structures that transport dopamine. This build-up can be seen using an imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.In patients with Parkinson's disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of the dopamine-containing nerve cells in the striatum. If this happens, the amount of Striascan attaching to these nerve cells is greatly reduced, which can be seen on the scan. This enables diseases related to Parkinson's disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer's disease.

How has Striascan been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, DaTSCAN, and do not need to be repeated for Striascan.As for every medicine, the company provided studies on the quality of Striascan. There was no need for 'bioequivalence' studies to investigate whether Striascan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Striascan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Striascan?

Because Striascan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Striascan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Striascan has been shown to be comparable to DaTSCAN. Therefore, the Agency's view was that, as for DaTSCAN, the benefit of Striascan outweighs the identified risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Striascan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Striascan have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Striascan are continuously monitored. Side effects reported with Striascan are carefully evaluated and any necessary action taken to protect patients.Striascan (ioflupane (123I))

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Stribild

What is Stribild and what is it used for?

Stribild is a medicine that contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil. It is used to treat patients from 12 years of age and weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used only in patients who have not received HIV medicines before or whose disease is not expected to be resistant to any of the antiviral agents in Stribild; it should only be used in patients under 18 years if other HIV medicines not including tenofovir disoproxil cannot be used because of side effects.

How is Stribild used?

Stribild can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection. Stribild is available as tablets (150 mg elvitegravir/150 mg cobicistat /200 mg emtricitabine/245 mg tenofovir disoproxil). The recommended dose is one tablet a day, taken with food. For further information, see the package leaflet.

How does Stribild work?

Stribild contains four active substances. Elvitegravir is a type of antiviral agent called an 'integrase inhibitor'. It blocks an HIV-1 enzyme called integrase, which is involved in thevirus's replication, thereby reducing the virus's ability to replicate normally and slowing down its spread. Cobicistatenhances the effects of elvitegravir, by prolonging the time for which elvitegravir continues to work. Tenofovir disoproxil is a 'prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir and emtricitabine are closely related types of antiviral agent called reverse transcriptase inhibitors. They block the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows the virus to replicate itself in the body. By blocking reverse transcriptase as well as integrase, Stribild reduces the amount of HIV-1 in the blood and keeps it at a low level.Stribild does not cure HIV-1 infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Stribild have been shown in studies?

Stribild was investigated in two main studies involving 1,422 adult patients with HIV-1 who had not been treated before, where Stribild was compared with other HIV medicines. The main measure of effectiveness was based on the reduction in viral load (the amount of HIV-1 virus in the blood). Patients whose viral load was reduced to less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.In the first study, involving 715 patients, Stribild was compared with the combination of ritonavir, atazanavir plus a medicine containing emtricitabine and tenofovir disoproxil (which are also contained in Stribild). After 48 weeks, around 90% of patients treated with Stribild (316 out of 353) responded to treatment compared with around 87% of patients treated with the comparator treatment (308 out of 355).In the second study, involving 707 patients, Stribild was compared with a medicine containing efavirenz, emtricitabine and tenofovir disoproxil. After 48 weeks, around 88% of patients treated with Stribild (305 out of 348) responded to treatment compared with around 84% of patients treated with the comparator medicine (296 out of 352).A third study involving 50 adolescents aged 12 to 18 years who had not been previously treated for HIV-1 showed that Stribild was also effective in reducing viral load in this age group; 88% (44 of 50 patients) responded to treatment after 24 weeks, and the response persisted after 48 weeks.

What are the risks associated with Stribild?

The most common side effects with Stribild are nausea (feeling sick) and diarrhoea, which can affect more than 1 in 10 people. In patients taking some of the components of Stribild, certain rare but serious side effects have been seen including lactic acidosis (excess lactic acid in the blood) and severe kidney problems that may also affect bones. For the full list of all side effects reported with Stribild, see the package leaflet.Stribild must not be used in patients who have previously stopped treatment with tenofovir disoproxil due to kidney toxicity. Stribild must not be used with several other medicines as it may interact with them, thereby reducing the effectiveness of treatment or increasing the risk of side effects. For the full list of restrictions, see the package leaflet.

Why is Stribild approved?

The European Medicines Agency decided that Stribild's benefits are greater than its risks and recommended that it be approved for use in the EU. In particular, the Agency concluded that the benefits of Stribild in reducing HIV viral load had been clearly shown in studies, and noted that it hasthe advantage of being taken once per day. The Agency also noted the risk of side effects affecting the kidneys, and recommended that kidney function should be carefully assessed before patients start taking Stribild and should be monitored during treatment.

What measures are being taken to ensure the safe and effective use of Stribild?

The company that markets Stribild will ensure that all doctors who are expected to prescribe Stribild are provided with educational materials containing important safety information. This will cover information on the risk of kidney disease in adults and adolescents and the measures to reduce this risk, including appropriate screening and monitoring of patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stribild have also been included in the summary of product characteristics and the package leaflet.

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Strimvelis

What is Strimvelis and what is it used for?

Strimvelis is a medicine used to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). ADA-SCID is a rare inherited condition in which there is a change (mutation) in the gene needed to make an enzyme called adenosine deaminase (ADA). As a result, patients lack the ADA enzyme. Because ADA is essential for maintaining healthy lymphocytes (white blood cells that fight off infections), the immune system of patients with ADA-SCID does not work properly and without effective treatment they rarely survive more than 2 years.Strimvelis is used in patients with ADA-SCID who cannot be treated by a bone-marrow transplant because they do not have a suitable, matched, related donor.Strimvelis contains cells derived from the patient's own bone marrow. Some of the cells (called CD34+ cells) have been genetically modified to contain a working gene for ADA. Strimvelis is a type of advanced therapy medicine called a 'gene therapy product'. This type of medicine works by delivering genes into the body.Because the number of patients with ADA-SCID is low, the disease is considered 'rare', and Strimvelis was designated an 'orphan medicine' (a medicine used in rare diseases) on 26 August 2005.Se

How is Strimvelis used?

Strimvelis can only be obtained with a prescription and treatment should only be given in a specialist transplant centre by a doctor who has experience in the treatment of ADA-SCID and the use of this type of medicine.To prepare Strimvelis, two samples of the patient's bone marrow are collected, one to make Strimvelis and one that is kept as a back-up in case Strimvelis cannot be given or does not work. Strimvelis can only be used to treat the same patient whose bone marrow was used to make the medicine. Strimvelis is given as an infusion (drip) into a vein over about 20 minutes. The dose depends on the bodyweight of the patient.Before Strimvelis is given, patients receive conditioning (preparatory) treatment with another medicine, busulfan, to get rid of their abnormal bone marrow cells. Patients are also given an antihistamine injection just before treatment to reduce the risk of allergic reactions.For further information, see the package leaflet.

How does Strimvelis work?

To make Strimvelis, a sample of the patient's bone marrow is collected. Then, CD34+ cells (cells that can make lymphocytes) are extracted from the bone marrow cells. A working gene for ADA is inserted into the CD34+ cells using a type of virus called a retrovirus, which has been altered genetically so that it can carry the ADA gene into cells and does not cause viral disease in humans.Once given back to the patient into a vein, Strimvelis is transported in the bloodstream to the bone marrow where the CD34+ cells start to grow and make normal lymphocytes that can produce ADA. These lymphocytes improve the patient's ability to fight infection, and so overcome the symptoms of the condition related to the immune system. The effects are expected to last for the patient's lifetime.

What benefits of Strimvelis have been shown in studies?

The benefits of Strimvelis have been shown in one main study involving 12 patients from 6 months to around 6 years old with ADA-SCID. Patients in the study had no appropriate bone marrow donor and alternative treatment had not worked or was not available. All patients were treated with Strimvelis and were still alive 3 years after treatment. The rate of severe infections declined after treatment and continued to decline with longer-term follow-up beyond 3 years.

What are the risks associated with Strimvelis?

The most common side effect with Strimvelis (which may affect up to 1 in 10 people) is pyrexia (fever). Serious side effects with Strimvelis may include effects linked to autoimmunity (when the immune system attacks the body's own cells) such as haemolytic anaemia (low red blood cell counts due to their too rapid breakdown), aplastic anaemia (low blood cell counts due to damaged bone marrow), hepatitis (liver inflammation), thrombocytopenia (low blood platelet count) and Guillain-Barre syndrome (damage to nerves that can result in pain, numbness, muscle weakness and difficulty walking).Strimvelis must not be used in patients who have leukaemia (cancer of white blood cells) or myelodysplasia (a type of bone marrow disorder) or have had these conditions in the past. It must not be used in patients who have tested positive for human immunodeficiency virus (HIV, the virus that causes AIDS) or some other infections, or in patients who have previously had gene therapy treatment.For the full list of restrictions and side effects reported with Strimvelis, see the package leaflet.

Why is Strimvelis approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Strimvelis's benefits are greater than its risks and recommended that it be approved for use in the EU. Strimvelis provides the opportunity of a cure that improves the working of the immune system for patients with ADA-SCID, which is a life-threatening condition. Results from the main study show that Strimvelis is effective at improving survival of ADA-SCID patients. Regarding safety, Strimvelis was relatively well tolerated although data are limited due to the small number of patients studied. Because Strimvelis is produced using a retrovirus, there could be a potential risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far. There is also a potential risk of autoimmune disease. However, measures are in place to monitor such events once the medicine is in use by using a registry of patients to study their long-term progress.

What measures are being taken to ensure the safe and effective use of Strimvelis?

A risk management plan has been developed to ensure that Strimvelis is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Strimvelis, including the appropriate precautions to be followed by healthcare professionals and patients.In addition, the company that makes Strimvelis will provide educational materials for patients and healthcare professionals with information on the medicine, and patients will have to sign a consent form before treatment is started. The company will also maintain a registry of patients treated with Strimvelis and monitor their progress regularly after treatment to study the long-term safety of the medicine.

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Suboxone

What is Suboxone and what is it used for?

Suboxone is a medicine to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Suboxone is used in adults and children over 15 years of age, who are also receiving medical, social and psychological support.Suboxone is contains two active substances, buprenorphine and naloxone.

How is Suboxone used?

Suboxone is available as a film to be placed either under the tongue or on the inside of the cheek, where it will dissolve in about 5 to 10 minutes.Suboxone must be used under the supervision of a doctor who has experience in the management of opioid addiction. The medicine can only be obtained by 'special' prescription, which means it is used under stricter conditions than normal. This medicine can itself cause addiction so this measure is required to reduce misuse.The precise way Suboxone is used depends on the patient's status: type of addiction, state of withdrawal, and whether the patient is already using another substitution treatment such as methadone before starting Suboxone.When starting treatment, Suboxone should be placed under the tongue. Once the patient is stabilised on a maintenance dose the film may also be placed inside the cheek. The recommended starting dose is 4 mg buprenorphine and 1 mg naloxone. The doctor may increase the dose depending on the patient's response but the daily dose should not exceed 24 mg buprenorphine. Once the patient has been stabilised, the maintenance dose may be reduced gradually and eventually treatment may be stopped. The patient's liver be checked before starting treatment with Suboxone and should also be monitored regularly during treatment. In patients who have mild to moderately reduced liver function lower starting doses are recommended.The effectiveness of Suboxone treatment depends on the patient also receiving other medical, social and psychological support.For more further information about using Suboxone, see the package leaflet or contact your doctor or pharmacist.

How does Suboxone work?

Suboxone contains two active substances. Buprenorphine is a partial opioid agonist which means that it acts like an opioid drug. Naloxone is an opioid antagonist; this means that it counteracts the effects of opioid drugs.The addition of naloxone helps to discourage inappropriate use, since if the medicine is misused it leads to withdrawal symptoms..

What benefits of Suboxone have been shown in studies?

Suboxone was as effective as buprenorphine on its own and more effective than placebo (a dummy treatment) at reducing the use of opioids. In a study involving 326 heroin-dependent patients, 17.8% of patients who received Suboxone had no trace of opioids in their urine after 4 weeks, compared with 5.8% of patients receiving placebo. Patients also used a validated questionnaire to record their cravings. The craving score, which was between 62.4 and 65.6 before treatment, decreased at the end of the study to 29.8 with Suboxone, compared with 55.1 with placebo.

What are the risks associated with Suboxone?

The most common side effects with Suboxone (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome.Suboxone must not be used in patients with severe respiratory insufficiency (difficulty breathing) or severe liver problems. It must also not be used in patients with acute alcohol intoxication (excessive alcohol consumption), delirium tremens (a condition caused by alcohol withdrawal) or together with medicines known as opioid antagonists used for the treatment of alcohol or opioid dependence.For the full list of side effects and restrictions of Suboxone, see the package leaflet.

Why has Suboxone been authorised in the EU?

Suboxone is as effective as buprenorphine on its own at reducing the use of opioids. The European Medicines Agency noted that the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential misuse of the medicine. The Agency decided that Suboxone's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Suboxone?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Suboxone have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Suboxone are continuously monitored. Side effects reported with Suboxone are carefully evaluated and any necessary action taken to protect patients.

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Sugammadex Adroiq

What is Sugammadex Adroiq and what is it used for?

Sugammadex Adroiq is a medicine used to reverse the effect of the muscle relaxants rocuronium and vecuronium. Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. Muscle relaxants make it easier for the surgeon to do the operation. Sugammadex Adroiq is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.Sugammadex Adroiq can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.Sugammadex Adroiq is a 'generic medicine'. This means that Sugammadex Adroiq contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU. The reference medicine for Sugammadex Adroiq is Bridion. For more information on generic medicines, see the question-and-answer document here.Sugammadex Adroiq contains the active substance sugammadex.

How is Sugammadex Adroiq used?

Sugammadex Adroiq can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Adroiq is given into a vein as a single bolus injection (given all at once).For more information about using Sugammadex Adroiq, see the package leaflet or contact your doctor or pharmacist.

How does Sugammadex Adroiq work?

The active substance in Sugammadex Adroiq, sugammadex attaches to the muscle relaxants rocuronium and vecuronium, stopping them from having an effect. As a result, the muscles contract and begin to work normally again, including the muscles that help the patient to breathe.Send

How has Sugammadex Adroiq been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Bridion, and do not need to be repeated for Sugammadex Adroiq.As for every medicine, the company provided studies on the quality of Sugammadex Adroiq. There was no need for 'bioequivalence' studies to investigate whether Sugammadex Adroiq is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Adroiq is given by injection into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Sugammadex Adroiq?

Because Sugammadex Adroiq is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.For the list of side effects and restrictions with Sugammadex Adroiq, see the package leaflet.

Why is Sugammadex Adroiq authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, SugammadexAdroiq has been shown to be comparable to Bridion. Therefore, the Agency's view was that, as for Bridion, the benefits of Sugammadex Adroiq outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sugammadex Adroiq?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Adroiq have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sugammadex Adroiq are continuously monitored. Suspected side effects reported with Sugammadex Adroiq are carefully evaluated and any necessary action taken to protect patients.

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Sugammadex Amomed

What is Sugammadex Amomed and what is it used for?

Sugammadex Amomed is a medicine used to reverse the effect of the muscle relaxants rocuronium and vecuronium. Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. Muscle relaxants make it easier for the surgeon to do the operation. Sugammadex Amomed is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.Sugammadex Amomed can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.Sugammadex Amomed contains the active substance sugammadex and is a 'generic medicine'. This means that Sugammadex Amomed contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU. The reference medicine for Sugammadex Amomed is called Bridion. For more information on generic medicines, see the question-and-answer document here.

How is Sugammadex Amomed used?

Sugammadex Amomed can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Amomed is given into a vein as a single bolus injection (given all at once). The dose depends on the patient's age and body weight and on how much the muscle relaxant is affecting the muscles.For more information about using Sugammadex Amomed, see the package leaflet or contact your doctor or pharmacist.

How does Sugammadex Amomed work?

The active substance in Sugammadex Amomed, sugammadex, is a selective relaxant binding agent. This means that it attaches to the muscle relaxants rocuronium and vecuronium, forming a complex that inactivates the muscle relaxants and stops them having an effect. As a result, the muscles contract and begin to work normally again, including the muscles that help the patient to breathe.Send

How has Sugammadex Amomed been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Bridion, and do not need to be repeated for Sugammadex Amomed.As for every medicine, the company provided data on the quality of Sugammadex Amomed. There was no need for 'bioequivalence' studies to investigate whether Sugammadex Amomed is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Amomed is given by injection into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Sugammadex Amomed?

Because Sugammadex Amomed is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sugammadex Amomed authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, SugammadexAmomed has been shown to be comparable to Bridion. Therefore, the Agency's view was that, as for Bridion, the benefits of Sugammadex Amomed outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sugammadex Amomed?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Amomed have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sugammadex Amomed are continuously monitored. Suspected side effects reported with Sugammadex Amomed are carefully evaluated and any necessary action taken to protect patients.

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Sugammadex Fresenius Kabi

What is Sugammadex Fresenius Kabi and what is it used for?

Sugammadex Fresenius Kabi is a medicine used to reverse the effect of the muscle relaxants rocuronium and vecuronium. Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. Muscle relaxants make it easier for the surgeon to do the operation. Sugammadex Fresenius Kabi is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.Sugammadex Fresenius Kabi can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.Sugammadex Fresenius Kabi contains the active substance sugammadex and is a 'generic medicine'. This means that Sugammadex Fresenius Kabi contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Bridion. For more information on generic medicines, see the question-and-answer document here.

How is Sugammadex Fresenius Kabi used?

Sugammadex Fresenius Kabi can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Fresenius Kabi is given into a vein as a single 'bolus' injection (given all at once). The dose depends on the patient's body weight and on how much the muscle relaxant is affecting the muscles.For more information about using Sugammadex Fresenius Kabi, see the package leaflet or contact your doctor or pharmacist.

How does Sugammadex Fresenius Kabi work?

The active substance in Sugammadex Fresenius Kabi, sugammadex, is a 'selective relaxant binding agent'. This means that it attaches to the muscle relaxants rocuronium and vecuronium forming a 'complex' that inactivates the muscle relaxants and stops them having an effect. As a result, the muscles contract and begin to work normally again, including the muscles that help the patient to breathe.Send

How has Sugammadex Fresenius Kabi been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Bridion, and do not need to be repeated for Sugammadex Fresenius Kabi.As for every medicine, the company provided data on the quality of Sugammadex Fresenius Kabi. There was no need for 'bioequivalence' studies to investigate whether Sugammadex Fresenius Kabi is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Fresenius Kabi is given by injection into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Sugammadex Fresenius Kabi?

Because Sugammadex Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sugammadex Fresenius Kabi authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Sugammadex Fresenius Kabi has been shown to be comparable to Bridion. Therefore, the Agency's view was that, as for Bridion, the benefits of Sugammadex Fresenius Kabi outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sugammadex Fresenius Kabi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Fresenius Kabi have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sugammadex Fresenius Kabi are continuously monitored. Suspected side effects reported with Sugammadex Fresenius Kabi are carefully evaluated and any necessary action taken to protect patients.

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Sugammadex Mylan

What is Sugammadex Mylan and what is it used for?

Sugammadex Mylan is a medicine used to reverse the effect of the muscle relaxants rocuronium and vecuronium. Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. Muscle relaxants make it easier for the surgeon to do the operation. Sugammadex Mylan is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.Sugammadex Mylan can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.Sugammadex Mylan contains the active substance sugammadex and is a 'generic medicine'. This means that Sugammadex Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Bridion. For more information on generic medicines, see the question-and-answer document here.

How is Sugammadex Mylan used?

Sugammadex Mylan can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Mylan is given into a vein as a single 'bolus' injection (given all at once). The dose depends on the patient's age and body weight and on how much the muscle relaxant is affecting the muscles.Sugammadex Mylan is not recommended for use in children and adolescents for recovery after vecuronium, or for rapid recovery after any muscle relaxant.For more information about using Sugammadex Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Sugammadex Mylan work?

The active substance in Sugammadex Mylan, sugammadex, is a 'selective relaxant binding agent'. This means that it attaches to the muscle relaxants rocuronium and vecuronium forming a 'complex' that inactivates the muscle relaxants and stops them having an effect. As a result, the effect of blockade ofSendthe muscles due to rocuronium and vecuronium on the muscles is reversed, and the muscles begin to work normally again, including the muscles that help the patient to breathe.

How has Sugammadex Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Bridion, and do not need to be repeated for Sugammadex Mylan.As for every medicine, the company provided studies on the quality of Sugammadex Mylan. There was no need for 'bioequivalence' studies to investigate whether Sugammadex Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Mylan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Sugammadex Mylan?

Because Sugammadex Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sugammadex Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, SugammadexMylan has been shown to be comparable to Bridion. Therefore, the Agency's view was that, as for Bridion, the benefits of Sugammadex Mylan outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sugammadex Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Mylan have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sugammadex Mylan are continuously monitored. Suspected side effects reported with Sugammadex Mylan are carefully evaluated and any necessary action taken to protect patients.

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Sugammadex Piramal

What is Sugammadex Piramal and what is it used for?

Sugammadex Piramal is a medicine used to reverse the effect of the muscle relaxants rocuronium and vecuronium. Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. Muscle relaxants make it easier for the surgeon to do the operation. Sugammadex Piramal is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.Sugammadex Piramal can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.Sugammadex Piramal is a 'generic medicine'. This means that Sugammadex Piramal contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU. The reference medicine for Sugammadex Piramal is Bridion. For more information on generic medicines, see the question-and-answer document here.Sugammadex Piramal contains the active substance sugammadex.

How is Sugammadex Piramal used?

The medicine can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Piramal is given into a vein as a single bolus injection (given all at once).For more information about using Sugammadex Piramal, see the package leaflet or contact your doctor or pharmacist.

How does Sugammadex Piramal work?

The active substance in Sugammadex Piramal, sugammadex, attaches to the muscle relaxants rocuronium and vecuronium, stopping them from having an effect. As a result, the muscles contract and begin to work normally again, including the muscles that help the patient to breathe.Send

How has Sugammadex Piramal been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Bridion, and do not need to be repeated for Sugammadex Piramal.As for every medicine, the company provided studies on the quality of Sugammadex Piramal. There was no need for 'bioequivalence' studies to investigate whether Sugammadex Piramal is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Piramal is given by injection into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Sugammadex Piramal?

Because Sugammadex Piramal is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.For the list of side effects and restrictions with Sugammadex Piramal, see the package leaflet.

Why is Sugammadex Piramal authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, SugammadexPiramal has been shown to be comparable to Bridion. Therefore, the Agency's view was that, as for Bridion, the benefits of Sugammadex Piramal outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sugammadex Piramal?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Piramal have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sugammadex Piramal are continuously monitored. Suspected side effects reported with Sugammadex Piramal are carefully evaluated and any necessary action taken to protect patients.

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Suliqua

What is Suliqua and what is it used for?

Suliqua is a medicine that is used together with metformin (another diabetes medicine), with or without SGLT-2 inhibitors (other diabetes medicines), for the treatment of adults with type 2 diabetes. It is used with appropriate diet and exercise to improve control of blood glucose (sugar) when the diabetes is not satisfactorily controlled.The active substances in Suliqua are insulin glargine and lixisenatide.

How is Suliqua used?

Suliqua is available as pre-filled disposable pens in two different strengths and can only be obtained with a prescription. It is given by injection under the skin of the belly, the thigh or the upper arm.Suliqua is given once a day up to 1 hour before a meal, preferably at the same time each day. Before Suliqua is started, the patient's insulin and diabetes medicines other than metformin and SGLT-2 inhibitors should be stopped. The dose is adjusted individually for each patient according to the patient's blood glucose.For more information about using Suliqua, see the package leaflet or contact your doctor or pharmacist.

How does Suliqua work?

Type 2 diabetes is a disease in which the level of blood glucose is high because either the body does not produce enough insulin, or the body is unable to use insulin effectively.One of the active substances in Suliqua, insulin glargine, is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood, thereby controlling the level of glucose in the blood. Insulin glargine reaches the bloodstream more slowly than human insulin after an injection and its action therefore lasts longer.The other active substance in Suliqua, lixisenatide, belongs to the class of medicines known as GLP-1 agonists. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps to control blood glucose levels.By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

What benefits of Suliqua have been shown in studies?

Suliqua was effective at controlling blood glucose in three main studies in patients with type 2 diabetes. The main measure of effectiveness in all three studies was the change in the blood levels of a substance called glycosylated haemoglobin (HbA1c). HbA1c gives an indication of how well blood glucose is controlled: a reduction in HbA1c levels indicates improved control of blood glucose levels. The first two studies looked at the change in HbA1c after 30 weeks, and the third study looked at the change after 26 weeks.The first study involved 1,170 patients whose blood glucose was not adequately controlled by metformin with or without another diabetes medicine taken by mouth. After stopping their diabetes medicines given by mouth except metformin, patients were given Suliqua or one of its two components, insulin glargine or lixisenatide. Results showed that Suliqua is more effective at controlling blood glucose levels than either component: average HbA1c at the start of the study was 8.1%, which fell after 30 weeks of treatment to 6.5% in the group using Suliqua, compared with 6.8% in the group using insulin glargine and 7.3% in the group using lixisenatide.The second study involved 736 patients whose blood glucose was not adequately controlled by a longacting insulin such as insulin glargine with or without one or two other diabetes medicines taken by mouth. After stopping all diabetes medicines given by mouth except metformin, patients were given either Suliqua or insulin glargine. Average HbA1c was 8.1% before patients started taking Suliqua or insulin glargine. After 30 weeks of treatment, average HbA1c fell to 6.9% in the group taking Suliqua and to 7.5% in patients receiving insulin glargine.The third study involved 514 patients whose blood glucose was not adequately controlled by metformin (alone or with other diabetes medicines taken by mouth) in combination with a diabetes medicine belonging to the class of GLP-1 agonists. Half of the patients were switched from their GLP-1 agonist medicine to Suliqua. After 26 weeks of treatment, average HbA1c dropped from 7.7% to 6.7% in the group treated with Suliqua and from 7.8% to 7.4% in the group that continued using a GLP-1 agonist.

What are the risks associated with Suliqua?

The most common side effect with Suliqua (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose); problems with the digestive system are common and include diarrhoea, vomiting and nausea (feeling sick). For the full list of all side effects and restrictions with Suliqua, see the package leaflet.

Why is Suliqua authorised in the EU?

The European Medicines Agency (EMA) decided that Suliqua's benefits are greater than its risks and recommended that it be approved for use in the EU.The Agency concluded that combination treatment with a long-acting insulin and a GLP-1 agonist such as Suliqua is an important option for patients with type 2 diabetes who are eligible for insulin or who need intensive insulin therapy. In these patients, Suliqua was effective at controlling glucose levels and reduced the risk of problems linked to intensive insulin therapy such as hypoglycaemia and weight gain. In terms of safety there were no new safety concerns with the combination of insulin glargine and lixisenatide in Suliqua compared with the components used separately.Suliqua Suliqua (insulin glargine / lixisenatide)

What measures are being taken to ensure the safe and effective use of Suliqua?

The company that markets Suliqua will provide educational materials for healthcare professionals and patients, explaining how to use the medicine safely, so as to reduce the risk of medication errors.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Suliqua have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Suliqua are continuously monitored. Side effects reported with Suliqua are carefully evaluated and any necessary action taken to protect patients.

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Sunitinib Accord

What is Sunitinib Accord and what is it used for?

Sunitinib Accord is a medicine used to treat adults with the following cancers:• gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs. Sunitinib Accord is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body. It is used after treatment with imatinib (another cancer medicine) has failed;• metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;• pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery. Sunitinib Accord is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas).Sunitinib Accord contains the active substance sunitinib and is a 'generic medicine'. This means that Sunitinib Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Sutent. For more information on generic medicines, see the question-and-answer document here.

How is Sunitinib Accord used?

Sunitinib Accord can only be obtained with a prescription and treatment should be started by doctors who have experience in the use of cancer medicines.Sunitinib Accord is available as capsules of various strengths to be taken by mouth.For GIST and metastatic renal cell carcinoma, Sunitinib Accord is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week 'rest period'. The dose can be adjusted according to the patient's response to the treatment, but should be kept within the range of 25 to 75 mg.For pancreatic neuroendocrine tumours, Sunitinib Accord is given at a dose of 37.5 mg once a day without a rest period. This dose may also be adjusted.SendFor more information about using Sunitinib Accord, see the package leaflet or contact your doctor or pharmacist.

How does Sunitinib Accord work?

The active substance in Sunitinib Accord, sunitinib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found at the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels. By blocking these enzymes, Sunitinib Accord can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.

How has Sunitinib Accord been studied?

Studies on the benefits and risks of the active substance, sunitinib, in the authorised uses have already been carried out with the reference medicine, Sutent, and do not need to be repeated for Sunitinib Accord.As for every medicine, the company provided studies on the quality of Sunitinib Accord. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Sunitinib Accord?

Because Sunitinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Sunitinib Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Sunitinib Accord has been shown to have comparable quality and to be bioequivalent to Sutent. Therefore, the Agency's view was that, as for Sutent, the benefits of Sunitinib Accord outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sunitinib Accord?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sunitinib Accord have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sunitinib Accord are continuously monitored. Side effects reported with Sunitinib Accord are carefully evaluated and any necessary action taken to protect patients.

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Sunlenca

What is Sunlenca and what is it used for?

Sunlenca is used, together with other medicines, to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Sunlenca is given when the virus is resistant to other treatments.Sunlenca contains the active substance lenacapavir.

How is Sunlenca used?

Sunlenca is available as tablets to be taken by mouth and as a solution for injection. Sunlenca tablets are taken at the start of the treatment, on days 1, 2 and 8. One week after that, patients are given Sunlenca injections every 26 weeks as maintenance treatment. Injections are given under the skin by a doctor or nurse.Before starting treatment, the doctor must ensure that the patient agrees to keep to the schedule of injections and should explain why this is important. The treatment schedule helps keep the virus under control. If a patient misses treatment doses, virus levels may increase, or the virus may become resistant to treatment. If treatment with Sunlenca is stopped, another treatment to suppress the virus must be started.Sunlenca can only be obtained with a prescription and should be prescribed by a doctor who has experience in the management of HIV infection.For more information about using Sunlenca, including the schedule for the injections, see the package leaflet or contact your doctor or pharmacist.

How does Sunlenca work?

The active substance in Sunlenca, lenacapavir, is a substance that binds to the proteins that make up the outer layer of the HIV-1 virus (the capsid). By binding to these proteins, Sunlenca interferes with different steps that are necessary for the virus to multiply. This reduces the amount of HIV in the blood and keeps it at a low level. Sunlenca does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Sunlenca have been shown in studies?

Sunlenca, taken together with other treatments to control HIV-1 infection, was effective at reducing the amount of HIV-1 virus in the blood (viral load) in one main study involving adults who had already tried other treatments and who did not respond or were no longer responding to most of the medicines used to control HIV-1 infection. In the first two weeks of the study, patients were given Sunlenca or placebo (a dummy treatment) in addition to their usual HIV medicines. After this time, 87.5% (21 out of 24) of the participants who were given Sunlenca showed a meaningful decrease in viral load, compared with 16.7% (2 out of 12) of the participants who were given a placebo. The 12 patients first given placebo then also received Sunlenca, and all 36 patients were given maintenance injections every 26 weeks. Viral load was under 50 copies of the virus per mL (which is a threshold considered indicative of durable clinical and immunological benefits) in 80.6% (29 out of 36) of patients after 26 weeks, and in 83.3% (30 out of 36) of patients after 52 weeks of treatment.

What are the risks associated with Sunlenca?

The most common side effects with Sunlenca (which may affect more than 1 in 100 people) are reactions at the injection site and nausea.For the full list of side effects of Sunlenca, see the package leaflet.

Why is Sunlenca authorised in the EU?

Sunlenca is a new type of treatment for controlling HIV-1 infection, which was effective at reducing viral load in patients with infections that are resistant to other treatments. These patients often lack options to manage their infection, and Sunlenca is considered to address an unmet medical need for this population. The side effects of Sunlenca are considered manageable.Therefore, the European Medicines Agency decided that Sunlenca's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sunlenca?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sunlenca have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sunlenca are continuously monitored. Suspected side effects reported with Sunlenca are carefully evaluated and any necessary action taken to protect patients.

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Sunosi

What is Sunosi and what is it used for?

Sunosi is a medicine used to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnoea.Narcolepsy is a long-term sleep disorder which affects the brain's ability to regulate the normal sleepwake cycle. This leads to symptoms such as an irresistible urge to sleep, even at inappropriate times and places, and disturbed night-time sleep. Sunosi is used in patients with or without cataplexy (episodes of severe muscle weakness that can cause collapse).Obstructive sleep apnoea is repeated interruption of breathing during sleep due to airways becoming blocked. Sunosi is used when other treatments, such as continuous positive airway pressure (CPAP, use of a ventilator to keep the airways open), have not satisfactorily improved the excessive daytime sleepiness.Sunosi contains the active substance solriamfetol.

How is Sunosi used?

Sunosi can only be obtained with a prescription and treatment should be started by a healthcare professional experienced in treatment of narcolepsy or obstructive sleep apnoea.Sunosi is available as tablets. The medicine should be taken once a day on waking up and the usual starting dose is 75 mg for narcolepsy or 37.5 mg for obstructive sleep apnoea. Depending on how well the medicine works, the dose may be increased up to a maximum of 150 mg once a day.For more information about using Sunosi, see the package leaflet or contact your doctor or pharmacist.

How does Sunosi work?

Although the way in which the active substance in Sunosi, solriamfetol, works is not fully understood, it is thought to act by increasing the levels of dopamine and noradrenaline in the brain. Dopamine and noradrenaline are neurotransmitters (chemical messengers) that carry signals between brain cells, including those that promote wakefulness.

What benefits of Sunosi have been shown in studies?

Sunosi has been investigated in 2 main studies where it was compared with placebo (a dummy treatment). The main measures of effectiveness were the score on the Epworth sleepiness scale (a standard scale measuring daytime sleepiness ranging from 0 to 24) and the length of time the patient could stay awake in a test called the maintenance of wakefulness test.In the first study involving 239 adults with narcolepsy, after 12 weeks of treatment, patients taking 75 mg Sunosi had an improvement of around 2.2 points on the Epworth sleepiness scale compared with placebo and patients taking 150 mg had an improvement of 3.8 points. In the maintenance of wakefulness test, patients taking 75 mg Sunosi did not have a significant improvement, while patients taking 150 mg could stay awake for 9.8 minutes longer than they could before treatment started, compared with 2.1 minutes longer for patients on placebo.In the second study involving 476 adults with obstructive sleep apnoea, after 12 weeks of treatment, patients taking 37.5 mg, 75 mg or 150 mg Sunosi had an improvement of 1.9, 1.7 or 4.5 points, respectively, on the Epworth sleepiness scale compared with placebo. In the maintenance of wakefulness test, patients taking 37.5 mg, 75 mg or 150 mg Sunosi could stay awake for 4.7, 9.1, and 11 minutes longer, respectively, than they could before treatment started, compared with 0.2 minutes longer for patients on placebo.

What are the risks associated with Sunosi?

The most common side effect with Sunosi, which may affect more than 1 in 10 people, is headache.Common side effects, which may affect up to 1 in 10 people, are decreased appetite, anxiety, insomnia (difficulty sleeping), irritability, bruxism (teeth grinding), dizziness, palpitations (a forceful heartbeat that may be rapid or irregular), cough, nausea (feeling sick), diarrhoea, dry mouth, abdominal pain (belly ache), constipation, vomiting, hyperhidrosis (excessive sweating), feeling jittery, chest discomfort and increased blood pressure.Sunosi must not be used in patients who have uncontrolled hypertension (high blood pressure) or serious heart problems including heart attack in the past year, unstable angina pectoris (chest pain caused by interruptions in blood supply to the heart, that may occur at rest or without an obvious trigger) and serious cardiac arrhythmias (abnormal or irregular heartbeat). It must not be taken at the same time as certain medicines called monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping these medicines.For the full list of side effects and restrictions with Sunosi, see the package leaflet.

Why is Sunosi authorised in the EU?

Sunosi was shown to reduce excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnoea. The safety profile was as expected for this type of medicine. Because the medicine could cause a harmful rise in blood pressure, patients should be monitored before and during treatment. The European Medicines Agency decided that Sunosi's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sunosi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sunosi have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sunosi are continuously monitored. Side effects reported with Sunosi are carefully evaluated and any necessary action taken to protect patients.

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Supemtek

What is Supemtek and what is it used for?

Supemtek is a vaccine used to protect adults against influenza (flu).Influenza is mainly caused by two kinds of influenza virus, known as influenza A and B. Each of these circulate as different strains and subtypes, which change over time.Supemtek contains proteins of four different influenza A and B virus strains (type A-H1N1, type AH3N2 and two type B strains), chosen based on the official recommendation for the annual flu season.

How is Supemtek used?

Supemtek is available as a solution for injection in a pre-filled syringe. The recommended dose is a single injection into a muscle, preferably in the upper arm.The vaccine can only be obtained with a prescription and should be used according to official recommendations.For more information about using Supemtek, see the package leaflet or contact your doctor or pharmacist.

How does Supemtek work?

Supemtek is a vaccine. Vaccines work by preparing the immune system (the body's natural defences) to defend the body against a specific disease.Supemtek contains proteins of four different strains of flu virus. When a person is given the vaccine, the immune system recognises the proteins as 'foreign' and makes defences against them. The immune system will then be able to respond more quickly when it is exposed to the virus. This will help to protect against the disease caused by the virus.Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season in the northern hemisphere. The composition of Supemtek will be updated annually according to WHO and EU recommendations.

What benefits of Supemtek have been shown in studies?

Supemtek was compared with another influenza vaccine that protects against the same four influenza A and B virus strains in 2 main studies involving over 10,000 people 18 years or more of age.One study looked at the number of people who caught flu at least 14 days after receiving either vaccine; the other study assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies. Taken together, results of the two studies showed that Supemtek was at least as effective as the comparator vaccine at protecting against influenza in adults.

What are the risks associated with Supemtek?

The most common side effects with Supemtek (which may affect more than 1 in 10 people) are reactions at the site of injection such as tenderness and pain. In the studies, these side effects occurred within three days of vaccination and resolved without consequences.For the full list of side effects and restrictions of Supemtek, see the package leaflet.

Why is Supemtek authorised in the EU?

Supemtek was shown to be as effective as a comparator vaccine at protecting against the 4 strains included in the vaccine. In terms of safety, side effects with Supemtek are similar to those observed with other influenza vaccines and are mostly mild to moderate in severity.The European Medicines Agency therefore decided that Supemtek's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Supemtek?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Supemtek have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Supemtek are continuously monitored. Side effects reported with Supemtek are carefully evaluated and any necessary action taken to protect patients.

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Sustiva

What is Sustiva and what is it used for?

Sustiva is an antiviral medicine that is used together with other antiviral medicines to treat patients aged 3 months or older and weighing at least 3.5 kg, who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

How is Sustiva used?

Sustiva can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection. It is available as capsules and tablets and must be given in combination with other antiviral medicines. It is recommended that Sustiva be taken on an empty stomach and without food, preferably at bedtime.The recommended dose of Sustiva for adults is 600 mg once a day. In patients aged 3 months to 17 years, the dose depends on body weight. For patients who cannot swallow, the capsule contents can be mixed with a small amount of food (one or two teaspoons). The dose of Sustiva may need to be adjusted in patients taking certain other medicines at the same time.For full details, see the summary of product characteristics (also part of the EPAR).

How does Sustiva work?

The active substance in Sustiva, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected. By blocking this enzyme, Sustiva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Sustiva does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

What benefits of Sustiva have been seen in studies?

Sustiva has shown benefit in controlling HIV infection in three main studies involving over 1,100 adults. In all of the studies, the main measure of effectiveness was the number of patients with undetectable levels of HIV 1 in their blood (viral loads) after 24 or 48 weeks of treatment:• in the first study, Sustiva in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine. 67% of the adults treated with Sustiva in combination with zidovudine and lamivudine had viral loads below 400 copies/ml after 48 weeks, compared with 54% of the patients treated with Sustiva and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;• the second study compared Sustiva in combination with nelfinavir and two other antiviral medicines with the same combination without Sustiva. The Sustiva combination was more effective than the combination without Sustiva: 70% and 30% of the patients, respectively, had viral loads below 500 copies/ml after 48 weeks;• the third study compared adding Sustiva or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection. More patients receiving Sustiva had viral loads below 400 copies/ml than those taking placebo after 24 weeksSimilar results have been seen in studies involving 182 patients (of whom 177 were children aged between 3 months and 18 years) in combination with nelfinavir and other antiviral medicines.

What are the risks associated with Sustiva?

The most common side effect with Sustiva (seen in more than 1 patient in 10) is rash. Sustiva is also commonly associated with dizziness, headache, nausea (feeling sick) and tiredness. Taking Sustiva with food may lead to an increase in the frequency of side effects. For the full list of all side effects reported with Sustiva, see the package leaflet.Sustiva must not be used in patients with severe liver disease. Sustiva can affect the electrical activity of the heart and so must also not be used in patients with heart problems such as changes in heart rhythm and activity, slow heart rate or heart failure or other conditions that can affect the heart's electrical activity, or who have close relatives that have died suddenly from a heart condition or were born with heart problems. Similarly, it must not be used in patients with altered levels of salts (electrolytes) such as potassium or magnesium in their blood.Sustiva must be avoided if patients are taking certain medicines because it can increase their side effects or reduce their effectiveness, or because the combination may increase effects on the heart. See the package leaflet for further details.

Why is Sustiva approved?

The European Medicines Agency decided that Sustiva's benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents and children three months of age and older and recommended that it be approved for use in the EU. The Agency noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working. It also noted that there is little information on the benefits of treatment that include a protease inhibitor in patients who have been treated with Sustiva in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.

What measures are being taken to ensure the safe and effective use of Sustiva?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sustiva have been included in the summary of product characteristics and the package leaflet.

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Sutent

What is Sutent?

Sutent is a medicine that contains the active substance sunitinib. It is available as capsules (12.5 mg, 25 mg, 37.5 mg and 50 mg).

What is Sutent used for?

Sutent is used to treat adults with the following types of cancer:• gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs. Sutent is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body. It is used after treatment with imatinib (another cancer medicine) has failed;• metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;• pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery. Sutent is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas).The medicine can only be obtained with a prescription.

How is Sutent used?

Treatment with Sutent should be started by doctors who have experience in administering cancer medicines.For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week 'rest period'. The dose can be adjusted according to the patient's response to the treatment, but should be kept within the range of 25 to 75 mg.For pancreatic neuroendocrine tumours, Sutent is given at a dose of 37.5 mg once a day without a rest period. This dose may also be adjusted.

How does Sutent work?

The active substance in Sutent, sunitinib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors at the surface of cancer cells, where they are involved in the growth and spread of cancer cells and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels. By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.

How has Sutent been studied?

Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine tumours that could not be removed with surgery. Sutent was also compared with another cancer medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not been treated before.The main measure of effectiveness in all of the studies was how long the patients lived without their tumours getting worse.

What benefit has Sutent shown during the studies?

Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours. Patients with GIST taking Sutent lived for an average of 26.6 weeks without the disease getting worse, compared with 6.4 weeks in the patients taking placebo. For pancreatic neuroendocrine tumours the figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.In metastatic renal cell carcinoma, patients taking Sutent lived for an average of 47.3 weeks without their disease worsening, compared with 22.0 weeks in the patients receiving interferon alfa.

What is the risk associated with Sutent?

The most common side effects with Sutent (seen in more than 1 in 10 patients) include fatigue (tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the mouth, indigestion and vomiting), respiratory (such as shortness of breath and cough) and skin disorders (such as skin discoloration, dryness of the skin and rash), hair color changes, dysgeusia (taste disturbances), epistaxis (nosebleeds), loss of appetite, hypertension (high blood pressure), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), hypothyroidism (an underactive thyroid gland), insomnia (difficulty falling and staying asleep), dizziness, headache, arthralgia (joint pain), neutropenia (low levels of neutrophils, a type of whiteblood cell), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), and leucopenia (low white blood cell counts).The most serious side effects reported with Sutent include heart and kidney failure, pulmonary embolism (clot in a blood vessel supplying the lungs), gastrointestinal perforation (holes in the wall of the gut), and internal haemorrhages (bleeding).For the full list of all side effects and restrictions with Sutent, see the package leaflet.

Why has Sutent been approved?

The CHMP decided that Sutent's benefits are greater than its risks and recommended that it be given marketing authorisation.Sutent was originally given 'conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

What measures are being taken to ensure the safe and effective use of Sutent?

A risk management plan has been developed to ensure that Sutent is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sutent, including the appropriate precautions to be followed by healthcare professionals and patients.

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Sycrest

What is Sycrest?

Sycrest is a medicine that contains the active substance asenapine. It is available as sublingual tablets (5 and 10 mg). Sublingual tablets are tablets that are placed under the tongue, where they dissolve.

What is Sycrest used for?

Sycrest is used to treat moderate to severe manic episodes (extremely high mood) in adults (aged 18 years or over) with bipolar disorder, a mental illness in which patients have periods of abnormally high mood alternating with periods of normal or depressed mood.The medicine can only be obtained with a prescription.

How is Sycrest used?

The recommended starting dose of Sycrest is 5 mg twice a day, one dose in the morning and one in the evening. This dose can be increased to 10 mg twice a day depending on how the patient responds.Sycrest tablets should not be chewed or swallowed. When taken in combination with other medicines, Sycrest should be taken last. The patient should avoid eating or drinking for 10 minutes after taking the medicine.

How does Sycrest work?

The active substance in Sycrest, asenapine, is an antipsychotic medicine. It is known as an 'atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by 'neurotransmitters', chemicals that allow nerve cells to communicate with each other. It is thought that Sycrest works by blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in bipolar disorder, Sycrest helps to normalise the activity of the brain, reducing the symptoms of the disease.

How has Sycrest been studied?

Four main studies looked at the use of Sycrest for manic episodes in bipolar disorder. In two of these studies, a total of 977 adult patients were given Sycrest, olanzapine (another antipsychotic medicine) or placebo (a dummy treatment) over three weeks. The other two studies lasted longer: one compared Sycrest with olanzapine over nine weeks in patients who had come from the short-term studies; and the other was a 12-week 'add on' study, in which 326 patients who were already being treated with another medicine (lithium or valproic acid) were also given either Sycrest or placebo. The main measure of effectiveness was the change in the patients' 'Young mania rating scale' (Y-MRS) score. The Y-MRS rates the severity of symptoms of manic episodes on a scale from 0 to 60.Sycrest was also studied in patients with schizophrenia. The studies included short- and long-term studies in patients receiving Sycrest, other medicines for schizophrenia (olanzapine, risperidone or haloperidol) or placebo.

What benefit has Sycrest shown during the studies?

Sycrest was effective at treating manic episodes in patients with bipolar disorder. In the first shortterm study, the reductions in Y-MRS score after three weeks were 11.5 and 14.6 points for Sycrest and olanzapine, respectively, compared with 7.8 points for placebo. The reductions for the second shortterm study were 10.8 and 12.6 points for Sycrest and olanzapine, respectively, and 5.5 for placebo.In the first long-term study, a reduction in Y-MRS score of 12.9 was seen in patients taking Sycrest compared with 16.2 in patients taking olanzapine. In the second long-term study, the reductions in Y-MRS score were 10.3 and 7.9 for Sycrest and placebo, respectively, after three weeks and 12.7 and 9.3 after 12 weeks.The studies on schizophrenia were not considered to have shown sufficient evidence of the effectiveness in treating this disease.

What is the risk associated with Sycrest?

The most common side effects with Sycrest (seen in more than 1 patient in 10) are anxiety and somnolence (sleepiness). For the full list of side effects and restrictions, see the package leaflet.

Why has Sycrest been approved?

The CHMP decided that Sycrest's benefits are greater than its risks and recommended that it be given marketing authorisation for the treatment of moderate to severe manic episodes in patients with bipolar disorder.The CHMP, however, did not recommend that the medicine be authorised to treat schizophrenia because of the lack of effectiveness shown in this illness.

What measures are being taken to ensure the safe and effective use of Sycrest?

A risk management plan has been developed to ensure that Sycrest is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sycrest, including the appropriate precautions to be followed by healthcare professionals and patients.

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Sylvant

What is Sylvant and what is it used for?

Sylvant is a medicine that is used to treat multicentric Castleman's disease in adults who are not infected with human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8).Castleman's disease is a disorder of the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream) in which cells in lymph nodes start growing abnormally, causing benign tumours. Multicentric means that the disease affects several lymph nodes as well as other organs in the body. Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen.Castleman's disease is rare, and Sylvant was designated an 'orphan medicine' (a medicine used in rare diseases) on 30 November 2007. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.Sylvant contains the active substance siltuximab.

How is Sylvant used?

Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision. It is given by infusion (drip) into a vein. The recommended dose is 11 mg per kilogram body weight, and the infusion should last around one hour.Sylvant is given every three weeks, until the patient no longer benefits from treatment.During the first 12 months of treatment the patient should have a blood test before each dose of Sylvant, and every nine weeks afterwards; treatment may need to be delayed in patients whose blood tests are abnormal or who have certain side effects.For more information about using Sylvant, see the summary of product characteristics or contact a doctor or pharmacist.

How does Sylvant work?

The active substance in Sylvant, siltuximab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6). Patients with Castleman's disease produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in the lymph nodes. By attaching to IL-6, siltuximab blocks its activity and stops abnormal cell growth, thus reducing the size of the lymph nodes and the symptoms of the disease.

What benefits of Sylvant have been shown in studies?

Sylvant has been investigated in one main study involving 79 adults with multicentric Castleman's disease who did not have HIV or HHV-8 infection. The effect of the medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients who responded to treatment for at least 18 weeks, as shown by a 50% reduction ('partial response') or complete disappearance ('complete response') of tumours and symptoms of the disease.Sylvant was more effective than placebo in reducing tumour size and disease symptoms: 17 out of 53 patients who received Sylvant showed a partial response and one showed a complete response, compared with none of the 26 patients who received placebo. This effect was maintained for almost one year.

What are the risks associated with Sylvant?

The most common side effects with Sylvant (which may affect more than 1 in 5 people) are infections (including upper respiratory tract infections such as those of the throat and nose), itching, rash, joint pain and diarrhoea. The most serious side effect is anaphylactic reaction (a severe allergic reaction).For the full list of side effects and restrictions of Sylvant, see the package leaflet.

Why is Sylvant authorised in the EU?

The European Medicines Agency decided that Sylvant's benefits are greater than its risks and it can be authorised for use in the EU. The Agency concluded that Sylvant has shown beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman's disease, and that this positive effect seems to be maintained over time. The Agency also acknowledged that there is an unmet medical need for these patients. Side effects of Sylvant were considered acceptable but further long-term data are to be collected.

What measures are being taken to ensure the safe and effective use of Sylvant?

The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety. The company will ensure that healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sylvant have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Sylvant are continuously monitored. Side effects reported with Sylvant are carefully evaluated and any necessary action taken to protect patients.

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Symkevi

What is Symkevi and what is it used for?

Symkevi is a medicine used to treat cystic fibrosis in patients aged 6 years and above. Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system and other organs. Cystic fibrosis affects the cells that produce mucus and digestive juices. As a result, these secretions become thick and cause blockage. Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection. In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.Symkevi is used in patients who have a mutation (change) called F508del in the gene for a protein called 'cystic fibrosis transmembrane conductance regulator' (CFTR).Symkevi is used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene. It is also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A>G, S945L, S977F, R1070W, D1152H, 2789+5G>A, 3272 26A>G, or 3849+10kbC>T.Symkevi contains the active substances tezacaftor and ivacaftor.Cystic fibrosis is rare, and Symkevi was designated an 'orphan medicine' (a medicine used in rare diseases) on 27 February 2017. Further information on the orphan designation can be found here:ema.europa.eu/en/medicines/human/orphan-designations/eu3171828.

How is Symkevi used?

Symkevi should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.Symkevi is available as tablets. Treatment is combined with a tablet containing ivacaftor alone.Symkevi should be taken in the morning and ivacaftor should be taken in the evening, about 12 hours later. The dose depends on the patient's age and weight.The doses of Symkevi and ivacaftor may need to be adjusted if the patient is also taking a type of medicine called a 'moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines forSend ufungal infections. The doses may also need to be adjusted in patients with reduced liver function.For more information about using Symkevi, see the package leaflet or contact your doctor or pharmacist.

How does Symkevi work?

Cystic fibrosis is caused by mutations in the CFTR gene. This gene makes the CFTR protein, which works on the surface of cells to regulate the production of mucus and digestive juices. The mutations reduce the number of CFTR proteins on the cell surface or affect the way the protein works.One of the active substances in Symkevi, tezacaftor, increases the number of CFTR proteins on the cell and the other, ivacaftor, increases the activity of the defective CFTR protein. These actions restore the activity of CFTR protein and make mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease.

What benefits of Symkevi have been shown in studies?

Symkevi taken together with ivacaftor was effective at improving lung function in 3 main studies of patients with cystic fibrosis aged 6 years and above.In the first 2 studies, the main measure of effectiveness was improvement in patients' FEV1. FEV1 is the maximum amount of air a person can breathe out in one second and is a measure of how well the lungs work.The first study involved 510 patients aged 12 years or above with cystic fibrosis who inherited the F508del mutation from both parents. Symkevi, taken with ivacaftor, was compared with placebo (a dummy treatment). After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.The second study involved 248 patients aged 12 years or above with cystic fibrosis who inherited the F508del mutation from one parent and also had another specific CFTR mutation. Symkevi, taken with ivacaftor, was compared with ivacaftor taken alone and with placebo. Lung function was measured after 4 weeks and 8 weeks of treatment. Patients who took Symkevi and ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took ivacaftor alone and a reduction of 0.3 percentage points in patients who took placebo.The effectiveness of Symkevi in a comparable group of children with cystic fibrosis aged 6 to 11 years was supported by a study in 54 children aged 6 to 11 years . This study looked at the effect of Symkevi on lung clearance index (LCI2.5), which indicates how well air is exchanged in the lungs. A fall in LCI2.5 indicates improvement. At the start of the study patients' LCI2.5 was on average 9.56. After 8 weeks of treatment with Symkevi and ivacaftor, LCI2.5 decreased by 0.51. The effectiveness of Symkevi in children aged between 6 and 11 years was also supported by evidence that the medicine behaves in the same way in their body as in older patients. However the dose needs to be adjusted based on the patient's weight and age.

What are the risks associated with Symkevi?

The most common side effects with Symkevi (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).For the full list of side effects and restrictions with Symkevi, see the package leaflet.

Why is Symkevi authorised in the EU?

Symkevi is effective in patients with cystic fibrosis who have inherited the F508del mutation from both parents or patients who have the F508del mutation from one parent and certain other mutations. In the former group, Symkevi could be a treatment option for those who cannot take a combination of ivacaftor and lumacaftor (another cystic fibrosis medicine), due to side effects or interactions with other medicines they are taking. In the latter group, there is a lack of authorised therapies. Regarding safety, the side effects of Symkevi are considered acceptable. Therefore, the European Medicines Agency decided that Symkevi's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Symkevi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symkevi have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Symkevi are continuously monitored. Side effects reported with Symkevi are carefully evaluated and any necessary action taken to protect patients.

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Symtuza

What is Symtuza and what is it used for?

Symtuza is an antiviral medicine used to treat human immunodeficiency virus type 1 (HIV-1) in adults and adolescents aged from 12 years (and weighing at least 40 kg). HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.

How is Symtuza used?

Symtuza can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.Symtuza is available as tablets, each containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide. The recommended dose is one tablet a day, taken with food.For more information about using Symtuza, see the package leaflet or contact your doctor or pharmacist.

How does Symtuza work?

Symtuza contains four active substances which work in different ways against HIV:• Darunavir is a type of antiviral agent called a 'protease inhibitor'. It blocks protease, an enzyme of the virus that allows it to reproduce itself in the cells it has infected. By blocking protease, Symtuza reduces the amount of HIV-1 in the blood and keeps it at a low level.• Cobicistat acts as a 'booster' to increase the effects of darunavir, by slowing down the breakdown of darunavir and therefore prolonging its antiviral activity in the body.• Tenofovir alafenamide is a 'prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a reverse transcriptase inhibitor, which means that it blocks the activity of the enzyme, reverse transcriptase, that the virus needs to reproduce itself.• Emtricitabine is also a reverse transcriptase inhibitor and it works in the same way as tenofovir.Symtuza does not cure HIV-1 infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.

What benefits of Symtuza have been shown in studies?

Because the individual active substances of Symtuza have previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Symtuza produced similar levels of active substances in the blood as the active substances given separately.In addition, one main study compared Symtuza with another antiviral medicine containing darunavir, cobicistat, emtricitabine and tenofovir disoproxil in 153 adult patients with HIV who had not been previously treated. Effectiveness was measured by a reduction in viral load (the amount of HIV-1 in the blood) to less than 50 copies/ml. Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was similar to the 74% (37 of 50) of patients who achieved it with the comparator.

What are the risks associated with Symtuza?

The most common side effects with Symtuza (which may affect more than 1 in 10 people) are diarrhoea, headache and rash. For the full list of side effects reported with Symtuza, see the package leaflet.Symtuza must not be taken by patients with severely reduced liver function. It must also not be taken with certain medicines that can reduce the effectiveness of Symtuza, as well as medicines that can increase the risk of serious side effects. For more information on the medicines that should not be taken with Symtuza, see the package leaflet.

Why is Symtuza authorised in the EU?

The active substances in Symtuza have already been shown to be effective when used individually, and combining them in a single tablet simplifies treatment. Symtuza was also as effective as a similar combination medicine containing tenofovir disoproxil in place of tenofovir alafenamide. Because tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil, Symtuza offers the possibility of reduced side effects.The European Medicines Agency decided that Symtuza's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Symtuza?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symtuza have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Symtuza are continuously monitored. Side effects reported with Symtuza are carefully evaluated and any necessary action taken to protect patients.

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Synagis

What is Synagis?

Synagis is a powder and solvent that are made up into a solution for injection. It contains the active substance palivizumab.

What is Synagis used for?

Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation. It is used in the following groups of children, who are at high risk for this disease:• children who are less than six months old and were born five or more weeks prematurely (at 35 weeks gestation or less);• children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;• children who are less than two years of age and were born with a serious heart disease.The medicine can only be obtained with a prescription.

How is Synagis used?

Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April. If possible, the first dose should be given before this season starts. Patients generally receive a total of five monthly injections into the thigh muscle.

How does Synagis work?

The active substance in Synagis, palivizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen). Palivizumab has been designed to attach to a protein called 'fusion protein A' on the surface of RSV. When palivizumab is attached to this protein, the virus becomes unable to enter the body's cells, especially those in the lungs. This helps to prevent RSV infection.

How has Synagis been studied?

The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season. Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease. In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.The effects of Synagis were first tested in experimental models before being studied in humans.

What benefit has Synagis shown during the studies?

Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo. This was a reduction of 55%. In children born with heart disease, there was a reduction of 45%.

What is the risk associated with Synagis?

The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are fever and rash. For the full list of all side effects reported with Synagis, see the package leaflet.Synagis must not be used in people who are hypersensitive (allergic) to palivizumab, any of the other ingredients or other 'humanised' monoclonal antibodies.

Why has Synagis been approved?

The CHMP decided that Synagis's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Synflorix

What is Synflorix and what is it used for?

Synflorix is a vaccine that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae, also called pneumococcus). It is used to protect infants and children aged between 6 weeks and 5 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae. Invasive disease results from the bacterium spreading through the body causing serious infections such as septicaemia (blood infection), meningitis (infection of the membranes around the brain and spine) and pneumonia.

How is Synflorix used?

Synflorix is available as a suspension for injection. It can only be obtained with a prescription.The vaccination schedule for Synflorix depends on the age of the child and should be based on official recommendations.• Infants aged between 6 weeks and 6 months are given a course of three doses with an interval of at least one month between each dose, with the first dose usually given at 2 months of age. A fourth ('booster') dose is recommended at least 6 months after the third dose, preferably when the child is between 12 and 15 months of age.• When Synflorix is given as part of a routine infant immunisation programme (when all infants in an area are vaccinated at around the same time), a course of two doses may be given 2 monthsapart, from the age of 6 weeks, followed by a booster dose at least 6 months later. However, children aged under 6 months with conditions that make them more likely to catch these invasive diseases, such as those with human immunodeficiency virus (HIV) infection, sickle cell disease or spleen problems, should be given three doses followed by a booster dose.• Premature babies (born between 27 and 36 weeks gestation) are given a course of three doses with an interval of at least one month between each dose, with the first dose given at 2 months of age. It is recommended that a booster dose be given at least 6 months after the third dose.• Infants aged between 7 and 11 months are given a course of two doses with an interval of at least one month between them. It is recommended that a booster dose is given at least 2 months after the second dose, during the child's second year of life.• Children aged between 12 months and 5 years are given a course of two doses with an interval of at least 2 months between them.The vaccine is given by injection into the thigh muscle in infants or into the shoulder muscle in young children.

How does Synflorix work?

Synflorix is a vaccine that protects against infections caused by S. pneumoniae. Vaccines work by 'teaching' the immune system (the body's natural defences) to defend the body against the infection. When a person is given the vaccine, the immune system recognises the parts of the bacterium in the vaccine as 'foreign' and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when it comes into contact with the bacterium again. This helps to protect against the disease.Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the 'capsule' that surrounds the S. pneumoniae bacterium. These polysaccharides have been purified, then conjugated (attached) to a carrier to help them to be recognised by the immune system. The vaccine is also adsorbed (fixed) onto an aluminium compound to stimulate a better response.Synflorix contains the polysaccharides from ten different types of S. pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). In Europe, it is estimated that these are responsible for 56 to 90% of the cases of invasive disease caused by S. pneumoniae in children under the age of 5 years.

What benefits of Synflorix have been shown in studies?

Synflorix was evaluated in a large study involving over 30,000 infants below 7 months of age who were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae. The children were followed up for an average of around 2 years. Synflorix was effective in protecting against invasive disease: no cases were seen among the 10,000 children given three doses of Synflorix and a booster dose, one case occurred among the 10,000 children given two doses of Synflorix and a booster dose and 12 cases occurred in 10,000 children given the comparator vaccine.Synflorix was also investigated in a large study involving around 24,000 children aged between 6 and 16 weeks that focussed mainly on the vaccine's benefit in preventing community acquired pneumonia. The children in this study were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae and were followed up for an average of 30 months. The percentage of children who had bacterial pneumonia was 2.3% (240 out of over 10,000) among those given Synflorix compared with 3% (304 out of over 10,000) among those given the comparator.Another main study looked at whether Synflorix prevents acute otitis media. The study involved almost 5,000 infants aged 3 months and compared an investigational vaccine that contains the same polysaccharides as Synflorix with another vaccine that is not active against S. pneumoniae (in this case, a vaccine against hepatitis A virus). The children were followed up until the end of their second year of life. The occurrence of the first episode of acute otitis media caused by S. pneumoniae was approximately halved among children who were given the investigational vaccine compared with those given the comparator. Based on a comparison of the immune response of Synflorix with the investigational vaccine used in the study, Synflorix is expected to provide similar protection against acute otitis media caused by S. pneumoniae.The ability of Synflorix to trigger the production of antibodies (immunogenicity) was assessed in one main study involving 1,650 healthy infants aged between 6 and 12 weeks. The study compared the immunogenicity of Synflorix with that of another vaccine that is authorised in the EU to protect children against S. pneumoniae infection, and which contains seven of the ten polysaccharides in Synflorix. Synflorix was as effective as the comparator in triggering the production of antibodies against five of the polysaccharides that the two vaccines shared in common (4, 9V, 14, 18C and 19F), but it was less effective than the comparator for two (6B and 23F). For the three additional polysaccharides (1, 5, 7F), Synflorix was effective in triggering the production of antibodies.Additional studies looked at the effects of booster vaccinations and vaccinations in older infants and children. The studies showed that Synflorix led to an increase in antibody production following booster vaccinations. In particular, two clinical studies in children aged 2 to 5 years investigated the ability of Synflorix to produce antibodies in this age group compared with other age groups. The children received one dose of Synflorix in the first study and two doses in the second study. The response to Synflorix in 2 to 5 year olds was similar to the younger age group, with better results in children who received two doses. In studies in infants and older children, although Synflorix produced a lower antibody response than the comparator vaccine, it fulfilled pre-defined criteria and was considered acceptable in this group.

What are the risks associated with Synflorix?

The most common side effects with Synflorix (which may affect more than 1 in 10 people) are pain, redness and swelling at the injection site, fever, drowsiness, irritability and loss of appetite. The majority of these reactions were of mild to moderate severity and were not long lasting. For the full list of side effects with Synflorix, see the package leaflet.Synflorix must not be used in children who have a high fever, but it can be given in children who have a mild infection such as a cold. For the full list of restrictions, see the package leaflet.

Why is Synflorix approved?

The European Medicines Agency noted that the immune system's response to Synflorix was comparable to its response to another vaccine, which is also authorised for the protection of children against S. pneumoniae in the EU. The Agency also noted that Synflorix contains additional polysaccharides from the types of S. pneumoniae that are responsible for disease in Europe and therefore decided that Synflorix's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Synflorix?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synflorix have been included in the summary of product characteristics and the package leaflet.

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Synjardy

What is Synjardy and what is it used for?

Synjardy is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes. It contains the active substances empagliflozin and metformin. Synjardy is used:• in patients whose diabetes is not sufficiently controlled by metformin alone;• in combination with other diabetes medicines in patients whose diabetes is not sufficiently controlled on these medicines plus metformin;• in patients who are already taking metformin and empagliflozin as separate tablets.

How is Synjardy used?

Synjardy is available as tablets containing 5 or 12.5 mg of empagliflozin with 850 or 1,000 mg of metformin, and can only be obtained with a prescription.The recommended dose of Synjardy is one tablet twice a day with meals, and treatment is normally started with a tablet that supplies the dose of metformin the patient is already taking, together with the lowest dose (5 mg) of empagliflozin. Doses are adjusted as necessary.If Synjardy is used in combination with insulin or a sulphonylurea (a medicine that increases the body's production of insulin), the doses of these medicines may need to be lowered to avoid hypoglycaemia (low blood sugar levels).For further information, see the package leaflet.

How does Synjardy work?

In type 2 diabetes the body does not make enough insulin to control the level of glucose (sugar) in the blood or the body is unable to use insulin effectively. This leads to a high level of glucose in the blood. The two active substances in Synjardy, empagliflozin and metformin, work in different ways to lower blood glucose, and thus to control symptoms of the disease.Empagliflozin works by blocking a protein in the kidneys (called sodium-glucose co-transporter 2 or SGLT2). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine. By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood. Empagliflozin has been authorised in the EU under the trade name Jardiance since 2014.Metformin works mainly by reducing the production of glucose in the body and reducing its absorption from the gut. Metformin has been available in the EU since the 1950s.

What benefits of Synjardy have been shown in studies?

The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such as pioglitazone or a type of diabetes medicine called a sulphonylurea). The studies compared the effect of empagliflozin plus metformin versus placebo (a dummy treatment) with metformin. The main measure of effectiveness was the reduction in the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment. HbA1c gives an indication of how well the blood glucose is controlled.The studies showed a greater reduction in HbA1c when empagliflozin plus metformin was given, compared with placebo plus metformin. Overall, the additional reduction was 0.58 percentage points with a combination providing 5 mg of empagliflozin twice daily, and 0.62 percentage points with the 12.5 mg dose, and these reductions were considered clinically relevant. Similar benefits were seen in the studies regardless of the other diabetes medicines being taken. In addition, the results indicated that the combination was associated with a beneficial decrease in body weight and blood pressure.Supportive evidence was provided from several further studies. Some of these were continuations of the main studies that suggested the benefits of the combination continued with longer therapy. Studies also indicated Synjardy was as effective as empagliflozin and metformin taken separately, and that the combination helped reduce HbA1c when added to treatment including insulin.Another main study showed that adding empagliflozin (one of the active substances of Synjardy) to usual treatment reduced adverse cardiovascular (heart and blood vessels) effects. The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke). The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease. On average, patients in the study were followed up for 3.1 years. In those receiving empagliflozin, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo. Among these, in patients who were also taking metformin (the other activesubstance in Synjardy), the three major cardiovascular events occurred in 9.9% (344 out of 3,459) of patients receiving empagliflozin and in 10.9% (189 out of 1,734) of patients receiving placebo.

What are the risks associated with Synjardy?

The most common side effects with Synjardy are hypoglycaemia (low blood sugar levels) when the medicine is taken with a sulphonylurea or insulin, infections of the urinary tract and genitals, and increased urination. For the full list of all side effects reported with Synjardy, see the package leaflet.Synjardy must not be used in patients with:• metabolic acidosis (when the body produces more acid than it gets rid of) or diabetic pre-coma (dangerous complications of diabetes);• severely reduced kidney function or conditions that could affect the kidneys such as dehydration, severe infection or a steep fall in blood pressure;• a condition that could reduce the supply of oxygen to body tissues (such as in patients with worsening heart failure, recent heart attack, breathing difficulty or a steep fall in blood pressure);• liver impairment, or problems with alcoholism or alcohol intoxication.For the full list of restrictions, see the package leaflet.

Why is Synjardy approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Synjardy's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the medicine could help produce a clinically meaningful reduction in blood glucose in patients with type 2 diabetes, and the benefits and risks were in line with those of the individual active substances. Synjardy was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease. Because of concerns about the balance of benefit and risk in patients with reduced kidney function taking the fixed-dose combination, the CHMP recommended restricting its use in these patients.

What measures are being taken to ensure the safe and effective use of Synjardy?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synjardy have been included in the summary of product characteristics and the package leaflet.

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