E.P.A.R s  Editing

Fabrazyme

What is Fabrazyme?

Fabrazyme is a medicine that contains the active substance agalsidase beta. It is available as a powder to be made into a solution for infusion (drip) into a vein.

What is Fabrazyme used for?

Fabrazyme is used to treat patients who have Fabry disease, a rare inherited disorder. Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (GL-3 or Gb3). If the enzyme is not present, GL-3 cannot be broken down and it builds up in the body's cells, such as kidney cells.People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems and stroke.The medicine can only be obtained with a prescription.

How is Fabrazyme used?

Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Fabrazyme.Fabrazyme is given once every two weeks as an infusion of 1 mg per kilogram body weight. The starting infusion rate should be no more than 0.25 mg per minute (15 mg per hour) to reduce the risk of infusion-related side effects. The infusion rate may be increased gradually with further infusions.Fabrazyme is intended for long-term use. The infusions are given in hospital but may be given at home if it has been shown that the patient is tolerating the infusions well.

How does Fabrazyme work?

Fabrazyme is an enzyme replacement therapy. Enzyme replacement therapies provide patients with the enzyme they are lacking. Fabrazyme is designed to replace the human enzyme alpha galactosidase A, which is lacking in patients with Fabry disease. The active substance in Fabrazyme, agalsidase beta, is a copy of the human enzyme, produced by a method known as 'recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme. The replacement enzyme helps to break down GL-3 and stops it building up in the patient's cells.

How has Fabrazyme been studied?

Fabrazyme has been investigated in three studies involving a total of 73 adults. In the main study, Fabrazyme was compared with placebo (a dummy treatment) in 58 patients. The study looked at the effects of the medicine on clearing GL-3 from the kidney. The effectiveness of Fabrazyme was also tested in 16 children aged between eight and 16 years who had Fabry disease.

What benefit has Fabrazyme shown during the studies?

In the main study, Fabrazyme produced a highly significant and almost complete clearance of GL-3 in the kidney cells after 20 weeks of treatment: 69% of the patients treated with Fabrazyme had the best score for clearance, compared with none of the patients in the placebo group.Children treated with Fabrazyme also had decreases in levels of GL-3 in the blood, with all children having normal levels after 20 weeks of treatment. This was accompanied by improvements in symptoms and quality of life.

What is the risk associated with Fabrazyme?

The most common side effects with Fabrazyme (seen in more than 1 patient in 10) are caused by the infusion rather than the medicine. These include fever, chills, headache, paraesthesia (abnormal sensations like pins and needles), nausea (feeling sick), vomiting and feeling cold. For the full list of all side effects reported with Fabrazyme, see the package leaflet.Fabrazyme must not be used in people who are hypersensitive (allergic) to agalsidase beta or any of the other ingredients.

Why has Fabrazyme been approved?

The CHMP decided that, for patients with Fabry disease, treatment with Fabrazyme might provide longterm clinical benefits. The CHMP decided that Fabrazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.

---

Fampridine Accord

What is Fampridine Accord and what is it used for?

Fampridine Accord is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.MS is a disease in which the immune system (the body's defences) attacks and damages the covering around the nerves and the nerves themselves in the brain and spinal cord.Fampridine Accord is a 'generic medicine'. This means that Fampridine Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Fampyra. For more information on generic medicines, see the question-and-answer document here.Fampridine Accord contains the active substance fampridine.

How is Fampridine Accord used?

Fampridine Accord can only be obtained with a prescription and treatment should be supervised by a doctor experienced in treating MS. The medicine is available as tablets. The recommended dose is one tablet taken without food, twice a day, 12 hours apart.After two or four weeks, patients are evaluated and those who have not shown an improvement should stop treatment. Patients continuing treatment beyond two or four weeks may have their treatment stopped if their walking ability worsens or if the patient does not report any benefit.For more information about using Fampridine Accord, see the package leaflet or contact your doctor or pharmacist.

How does Fampridine Accord work?

For the body's muscles to contract, electrical impulses are transmitted along the nerves to the muscles. In MS, this transmission of electrical impulses is impaired when the covering around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.The active substance in Fampridine Accord, fampridine, is a potassium channel blocker. It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells. This isSendbelieved to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.

How has Fampridine Accord 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, Fampyra, and do not need to be repeated for Fampridine Accord.As for every medicine, the company provided studies on the quality of Fampridine 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 Fampridine Accord?

Because Fampridine 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 Fampridine Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, FampridineAccord has been shown to have comparable quality and to be bioequivalent to Fampyra. Therefore, the Agency's view was that, as for Fampyra, the benefits of Fampridine 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 Fampridine Accord?

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

---

Fampyra

What is Fampyra and what is it used for?

Fampyra is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.It contains the active substance fampridine.

How is Fampyra used?

Fampyra is available as 10 mg tablets taken without food twice a day, 12 hours apart.After two to four weeks, patients are evaluated and those who have not shown an improvement should stop treatment. Treatment should also be stopped if a patient's walking ability worsens or if the patient does not report any benefit.The medicine can only be obtained with a prescription, and should be prescribed by a doctor experienced in treating MS. For further information, see the package leaflet.

How does Fampyra work?

For the body's muscles to contract, electrical impulses are transmitted along the nerves to the muscles. In MS, this transmission of electrical impulses is impaired when the protective sheaths aroundthe nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.The active substance in Fampyra, fampridine, is a potassium channel blocker. It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells. This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.

What benefits of Fampyra have been shown in studies?

Two main studies in 540 patients with multiple sclerosis showed that Fampyra was more effective than placebo (a dummy treatment) at improving walking speed. The patients were treated for 9 or 14 weeks, with their waking speed measured along a 25 feet (7.5 metres) footpath.In one of the studies 35% of patients taking Fampyra had higher walking speed on at least three out of four occasions than their quickest speed before treatment compared with 8% of patients taking placebo . In the second study the results were similar, with 43% of patients in the Fampyra group surpassing their previous best speed on three out of four occasions, compared with 9% in the placebo group.A third study in 633 patients measured improvements in walking ability over 24 weeks using a rating scale known as the multiple sclerosis walking scale (MSWS), where patients rated how well they were able to do various activities such as walking, running or climbing stairs. In this study, 43% of patients taking Fampyra had at least an 8-point improvement in their MSWS score compared with 34% of those on placebo. (An 8-point improvement is considered clinically significant in this scale, which ranges from 0 to 100).

What are the risks associated with Fampyra?

The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness). The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection. For the full list of all side effects reported with Fampyra, see the package leaflet.Fampyra must not be used with other medicines that contain fampridine or medicines known as 'inhibitors of organic cation transporter 2' such as cimetidine. It must not be used in patients who have seizures or have ever had seizures or in patients with kidney problems. For the full list of restrictions, see the package leaflet.

Why is Fampyra approved?

The studies with Fampyra showed that the medicine is likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients. With regard to the medicine's safety, serious side effects with Fampyra are rare.The European Medicines Agency therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.Fampyra was originally given 'conditional approval' because there was more evidence to come about the medicine. 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 Fampyra?

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

---

Fareston

What is Fareston?

Fareston is a medicine that contains the active substance toremifene. It is available as white, round tablets (60 mg).

What is Fareston used for?

Fareston is used to treat hormone-dependent metastatic breast cancer in women who have been through the menopause. 'Metastatic' means that the cancer has spread to other parts of the body. Fareston is not recommended for patients with oestrogen-receptor-negative tumours (where the cancer cells do not have receptors for the hormone oestrogen on their surface). The medicine can only be obtained with a prescription.

How is Fareston used?

The recommended dose of Fareston is one tablet once a day. It should be used with caution in patients who have problems with their liver.

How does Fareston work?

Most types of breast cancer grow in response to the hormone oestrogen. The active substance in Fareston, toremifene, is an anti-oestrogen. It attaches to the receptors for oestrogen on the surface of cells, where its main effect is to block the effects of the hormone. As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.

How has Fareston been studied?

The effects of Fareston were first tested in experimental models before being studied in humans. Fareston has been studied in 1,869 postmenopausal women with metastatic breast cancer in four main studies. The effects of Fareston were compared with those of tamoxifen (another anti-oestrogen used to treat breast cancer). The main measures of effectiveness were response rate (the number of patients whose tumours responded to treatment), time to progression (the length of time until the disease got worse) and survival.

What benefit has Fareston shown during the studies?

The effectiveness of Fareston and tamoxifen were equivalent. Looking at the results of the three largest main studies taken together, patients taking Fareston had similar response rates, times to progression and survival rates as the patients taking tamoxifen. This was confirmed in the fourth study.

What is the risk associated with Fareston?

The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating. For the full list of all side effects reported with Fareston, see the Package Leaflet.Fareston should not be used in people who may be hypersensitive (allergic) to toremifene or any of the other ingredients. It must not be used on a long-term basis in patients who have endometrial hyperplasia (thickening of the lining of the womb) or severe liver problems. Fareston must not be used in patients with 'QT prolongation' (a disruption of the electrical activity of the heart), electrolyte disturbances (altered levels of salts in the blood) especially hypokalaemia (low potassium levels), bradycardia (a very slow heart rate), heart failure (an inability of the heart to pump enough blood to the rest of the body) or a history of symptomatic arrhythmias (abnormal heart rhythms), or in patients also taking other medicines that can cause QT prolongation. A list of these medicines is given in the Package Leaflet.

Why has Fareston been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with oestrogen-receptor-positive tumours. Therefore, the Committee decided that Fareston's benefits are greater than its risks for the first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. The Committee recommended that Fareston be given marketing authorisation.

---

Farydak

What is Farydak and what is it used for?

Farydak is a cancer medicine used in combination with two other medicines, bortezomib and dexamethasone, to treat multiple myeloma (a cancer of the bone marrow). It is given to adults whose disease has come back or got worse after at least two previous treatments, including bortezomib and an immunomodulatory medicine (a medicine that acts on the immune system).Farydak contains the active substance panobinostat.Because the number of patients with multiple myeloma is low, the disease is considered 'rare', and Farydak was designated an 'orphan medicine' (a medicine used in rare diseases) on 8 November 2012.

How is Farydak used?

Treatment with Farydak must be started by a doctor experienced in the treatment of cancer and the medicine can only be obtained with a prescription.Farydak is available as capsules (10, 15 and 20 mg) and it is given in 21-day treatment cycles, together with bortezomib and dexamethasone. The recommended starting dose of Farydak is 20 mg, taken on days 1, 3, 5, 8, 10 and 12 of the cycle. Patients are given the medicine for 8 cycles, and further 8 cycles of treatment are recommended in those that benefit. The doctor may have to adjust ordelay the dose in patients who experience severe side effects. For further information, see the summary of product characteristics (part of the product information).

How does Farydak work?

The active substance in Farydak, panobinostat, is a type of medicine called a histone deacetylase (HDAC) inhibitor. It blocks the activity of enzymes called histone deacetylases (HDACs), which are involved in switching the activity of genes on and off within cells. In multiple myeloma, panobinostat is expected to keep genes that suppress the division and growth of the cancer cells switched 'on'. This is expected to stop the cancer cells from multiplying and to activate processes that kill the cell, thereby slowing down the growth of the cancer.

What benefits of Farydak have been shown in studies?

The benefits of Farydak have been shown in one main study involving 768 patients with multiple myeloma that had come back after previous treatments. The medicine was compared with placebo (a dummy treatment) as an addition to treatment with bortezomib and dexamethasone. The main measure of effectiveness was the average length of time before the patient's disease got worse again (progression-free survival), which was 12 months in patients given Farydak, compared with around 8 months in those given placebo.When results were analysed just for the group of patients who had previously received at least two previous treatments, including bortezomib and an immunomodulatory medicine (thalidomide, lenalidomide or pomalidomide), the average time until the myeloma got worse was 12.5 months with Farydak, versus 4.7 months with placebo.

What are the risks associated with Farydak?

The most common side effects with Farydak (which may affect more than 1 in 10 people) are diarrhoea, tiredness, nausea (feeling sick) and vomiting, and effects on the blood such as thrombocytopenia (low levels of blood platelets which are important for blood clotting), anaemia and neutropenia and lymphopenia (low levels of certain white blood cells). The most significant effects that led to patients having to stop treatment (which happened in about 4 patients in 10) were diarrhoea, weakness and tiredness, and pneumonia (lung infection). Effects on the heart occurred in between 1 and 2 patients in 10 and included tachycardia (increased heart rate), palpitations, and irregular heart rhythms (atrial fibrillation, sinus tachycardia); more rarely patients had changes in electrical conduction in the heart (prolonged QTc interval). For the full list of all side effects reported with Farydak, see the package leaflet.Farydak must not be used in women who are breast-feeding. For the full list of restrictions, see the package leaflet.

Why is Farydak approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) considered the increase in progression free survival to be clinically significant although it noted that a benefit in overall survival had not yet been shown. In addition, panobinostat works in a different way to existing treatments. This means that for patients who have previously received at least two previous treatments, including bortezomib and immunomodulatory agents, who have limited treatment options and therefore a high unmet medical need, it offers a new alternative. Although the side effects were of concern and could not be justified in patients who could be given less toxic treatments, the CHMP considered that they were acceptable in this previously treated subgroup in view of the lack of alternatives, and could bemanaged. The CHMP therefore decided that Farydak's benefits are greater than its risks in this group and recommended that it be approved for use in the EU.

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

A risk management plan has been developed to ensure that Farydak 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 Farydak, including the appropriate precautions to be followed by healthcare professionals and patients.In addition, the company that markets Farydak will provide educational materials for patients, including a patient card, to help them take the medicine correctly. It will also provide a final analysis from the main study on how long patients who have been treated with the medicine survive.Further information can be found in the summary of the risk management plan.

---

Fasenra

What is Fasenra and what is it used for?

Fasenra is an asthma medicine used to treat adults with a particular type of asthma called eosinophilic asthma.It is used as an additional treatment in adults with severe asthma that is not adequately controlled by a combination of high-dose inhaled corticosteroids plus medicines called long-acting beta-agonists.Fasenra contains the active substance benralizumab.

How is Fasenra used?

Fasenra is available as a solution for injection in pre-filled syringes and pre-filled pens. It can only be obtained with a prescription and treatment should be started by doctors with experience in the diagnosis and treatment of severe asthma.The recommended dose is 30 mg injected under the skin of the thighs or belly every 4 weeks for the first 3 doses, and every 8 weeks afterwards. If the injection is given by a doctor or carer, it can also be given under the skin of the upper arm. If agreed with the treating doctor, patients already using Fasenra and with no history of severe allergic reactions, or their carers, can inject Fasenra themselves after proper training, including on how to watch out for signs and symptoms of allergic reactions. Fasenra should be given for as long as the patient benefits from it, and doctors should re-assess at least once a year whether treatment should be continued.For more information about using Fasenra, see the package leaflet or contact your doctor or pharmacist.

How does Fasenra work?

In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs. The active substance in Fasenra, benralizumab, is a monoclonal antibody (a type of protein) designed to attach to receptors (targets) called interleukin-5 receptors on the surface of eosinophils. By attaching to interleukin-5 receptors,Fasenra activates the immune system (the body's natural defences) to kill the eosinophils in the blood and lungs. This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.

What benefits of Fasenra have been shown in studies?

Fasenra was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving a total of 2,511 patients with eosinophilic asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and long-acting beta-agonists. Among patients with the highest number of blood eosinophils before treatment, the number of severe flareups per year was 0.66 in patients treated with Fasenra (given every 4 weeks for the first 3 doses and every 8 weeks afterwards), compared with 1.14 in patients given placebo (a dummy treatment).A third study involving 220 patients showed that more patients given Fasenra had their condition improved to the extent that they could reduce their dose of corticosteroids by an average of 75% compared with 25% of those given placebo.

What are the risks associated with Fasenra?

The most common side effects with Fasenra (which may affect up to 1 in 10 people) include headache and pharyngitis (sore throat). For the full list of side effects and restrictions of Fasenra, see the package leaflet.

Why is Fasenra authorised in the EU?

Fasenra has been shown to be more effective than placebo at reducing the number of asthma flare-ups and the need for corticosteroid treatment. The medicine is well tolerated with few side effects. The European Medicines Agency therefore decided that Fasenra'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 Fasenra?

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

---

Faslodex

What is Faslodex and what is it used for?

Faslodex is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in the following patients:• postmenopausal women with a type of breast cancer known as 'oestrogen-receptor positive cancer' who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen;• women with a type of breast cancer known as 'HR-positive, HER-2 negative cancer' who have previously had hormonal treatment. In women with this type of breast cancer, Faslodex is used in combination with palbociclib (another cancer medicine).Faslodex contains the active substance fulvestrant.

How is Faslodex used?

Faslodex is available as a solution for injection in prefilled syringes (250 mg). The recommended dose is 500 mg given once a month, with an additional 500-mg dose two weeks after the first dose. The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.Faslodex can only be obtained with a prescription.

How does Faslodex work?

Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells. The active substance in Faslodex, fulvestrant, is an anti-oestrogen. It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall. As a result, the cancer cells are not stimulated to grow by oestrogen and this slows down the growth of the tumour.

What benefits of Faslodex have been shown in studies?

Five main studies showed that Faslodex is effective at prolonging the length of time patients live without their disease getting worse.Two of these studies in 851 women showed that Faslodex was as effective as another medicine, anastrozole: women receiving Faslodex lived for an average of 5.4 months without their disease getting worse, compared with 4.1 months for those taking anastrozole.A third study in 736 women showed that the higher dose of 500 mg of Faslodex was more effective than 250 mg: women receiving the higher dose lived for an average of 6.5 months without their disease getting worse, compared with 5.5 months in those receiving the lower dose.The fourth study, in 462 women with advanced or metastatic breast cancer who had not been treated with hormonal therapy, showed that women treated with Faslodex (500 mg once a month) lived for an average of 16.6 months without their disease getting worse, compared with 13.8 months for women given anastrozole.Finally, a study investigating the use of Faslodex in combination with palbociclib in 521 women with(HR)-positive (HER2)-negative advanced or metastatic breast cancer showed that women treated with Faslodex plus palbociclib lived for an average of 9.2 months without their disease getting worse, compared with 3.8 months for women given Faslodex on its own.

What are the risks associated with Faslodex?

When Faslodex is used on its own, the most common side effects (seen in more than 1 patient in 10) are injection-site reactions (such as pain or inflammation), weakness, nausea (feeling sick) and increased liver enzyme levels in the blood (a sign of liver problems). When used in combination with palbociclib, the most common side effects with Faslodex (seen in more than 2 patients in 10) are low levels of white and red blood cells, low blood platelet counts, infections, tiredness, nausea, stomatitis (inflammation of the lining of the mouth) and diarrhoea. The most common serious side effects were low levels of white and red blood cells, low levels of blood platelets, infections, increased liver enzyme levels and tiredness.Faslodex must not be used in women who are pregnant or breast-feeding, or in patients who have severe liver disease. For the full list of all side effects and restrictions with Faslodex, see the package leaflet.

Why is Faslodex approved?

Studies showed that Faslodex, an anti-oestrogen medicine, is effective at prolonging the time patients with oestrogen-receptor positive breast cancer can live without their disease getting worse. In addition, the medicine is effective in combination with palbociclib in patients with HR-positive, HER-2 negative breast cancer. The European Medicines Agency concluded that the benefits seen in studies with Faslodex 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 Faslodex?

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

---

Fasturtec

What is Fasturtec?

Fasturtec is a medicine that contains the active substance rasburicase. It is available as a powder and solvent that are made up into a solution for infusion (drip) into a vein.

What is Fasturtec used for?

Fasturtec is used to treat and prevent high levels of uric acid in the blood in order to prevent kidney failure. It is used in adults and children with blood cancers who are at risk of a sudden rise in uric acid levels when they start to receive chemotherapy (medicines to treat cancer).The medicine can only be obtained with a prescription.

How is Fasturtec used?

Fasturtec treatment should be supervised by a doctor who has been trained in the use of chemotherapy for blood cancers. Fasturtec is given immediately before or during the start of chemotherapy. The recommended dose is 0.2 mg per kilogram body weight in both children and adults, given as a daily infusion for up to seven days. The duration of treatment is adjusted depending on the patient's blood levels of uric acid and the doctor's judgment. The infusion should last 30 minutes.

How does Fasturtec work?

Uric acid is a by-product of the breakdown of cells. Patients undergoing chemotherapy may be at risk of rapid tumour lysis, where many cancer cells are broken down at once causing a sudden rise of uric acid in the blood which can cause damage to the kidneys.The active substance in Fasturtec, rasburicase, is an enzyme called urate oxidase, which transforms uric acid into another chemical called allantoin, which can easily be excreted by the kidneys in the urine. This helps to reduce the levels of uric acid in the blood, thereby reducing the load on the kidney and preventing any damage. The enzyme was originally extracted from a fungus, but in Fasturtec it is produced by a method known as 'recombinant DNA technology': it is made by a yeast into which a gene (DNA) has been introduced that makes it able to produce urate oxidase.

How has Fasturtec been studied?

The benefits of Fasturtec were first studied in three main studies involving a total of 293 patients, including adults and children. Two of the studies were designed to define the best dose to use. Fasturtec was only compared with another treatment (allopurinol, the standard treatment for reducing uric acid levels) in one of the studies, which included 52 patients.An additional study looked at the effects of Fasturtec in 21 children (aged between 6 months and 16 years) with blood cancers of whom 62% had uric acid levels that were too high. Fasturtec was not compared with another medicine in this study.The main measures of effectiveness were based on the reduction in blood uric acid levels.

What benefit has Fasturtec shown during the studies?

The dose-finding studies showed that, after 48 hours, Fasturtec at a daily dose of 0.2 mg per kg reduced the uric acid levels to normal in 95% of patients. In the comparative study, Fasturtec was more effective than allopurinol: over the first 96 hours after treatment, patients treated with Fasturtec had a lower average blood level of uric acid than the patients treated with allopurinol (128.1 and 328.5 mg.h/dl, respectively).In the additional study, none of the 21 children treated with Fasturtec had high uric acid levels after 24 or 48 hours. This study also showed improvement in kidney function.

What is the risk associated with Fasturtec?

The most common side effects with Fasturtec (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, headache, fever and diarrhoea. For the full list of all side effects reported with Fasturtec, see the package leaflet.Fasturtec must not be used in patients with a deficiency in (low levels of) glucose 6 phosphate dehydrogenase (G6PD) or other metabolic disorders known to cause haemolytic anaemia (low haemoglobin levels caused by the abnormal breakdown of red blood cells). For the full list of restrictions, see the package leaflet.

Why has Fasturtec been approved?

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

---

Febuxostat Krka

What is Febuxostat Krka and what is it used for?

Febuxostat Krka is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or 'urate' in the blood). Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys. When this happens in the joints and causes pain, it is known as 'gout'. Febuxostat Krka is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi ('stones', larger deposits of urate crystals that can cause joint and bone damage).Febuxostat Krka is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).Febuxostat Krka contains the active substance febuxostat and is a 'generic medicine'. This means that Febuxostat Krka contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Adenuric. For more information on generic medicines, see the question-and-answer document here.

How is Febuxostat Krka used?

Febuxostat Krka is available as tablets (80 and 120 mg) and can only be obtained with a prescription.For the treatment of long-term hyperuricaemia, the recommended dose of Febuxostat Krka is 80 mg once a day. This usually reduces blood uric acid levels within 2 weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after 2 to 4 weeks. Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first 6 months of treatment with Febuxostat Krka. Febuxostat Krka treatment should not be stopped if an attack of gout occurs.For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day. Febuxostat Krka should be started 2 days before chemotherapy and continued for at least 7 days.For more information about using Febuxostat Krka, see the package leaflet or contact your doctor or pharmacist.

How does Febuxostat Krka work?

The active substance in Febuxostat Krka, febuxostat, reduces the formation of uric acid. It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body. By reducing the production of uric acid, Febuxostat Krka can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up. This can reduce the symptoms of gout. Keeping uric acid levels low for long enough can also shrink tophi. In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.

How has Febuxostat Krka 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, Adenuric, and do not need to be repeated for Febuxostat Krka.As for every medicine, the company provided studies on the quality of Febuxostat Krka. 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 Febuxostat Krka?

Because Febuxostat Krka 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 Febuxostat Krka authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Febuxostat Krka has been shown to have comparable quality and to be bioequivalent to Adenuric. Therefore, the Agency's view was that, as for Adenuric, the benefit of Febuxostat Krka 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 Febuxostat Krka?

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

---

Febuxostat Mylan

What is Febuxostat Mylan and what is it used for?

Febuxostat Mylan is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or 'urate' in the blood). Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys. When this happens in the joints and causes pain, it is known as 'gout'. Febuxostat Mylan is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi ('stones', larger deposits of urate crystals that can cause joint and bone damage).Febuxostat Mylan is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).Febuxostat Mylan contains the active substance febuxostat and is a 'generic medicine'. This means that Febuxostat Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Adenuric. For more information on generic medicines, see the question-and-answer document here.

How is Febuxostat Mylan used?

Febuxostat Mylan is available as tablets (80 and 120 mg) and can only be obtained with a prescription.For the treatment of long-term hyperuricaemia, the recommended dose of Febuxostat Mylan is 80 mg once a day. This usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks. Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Febuxostat Mylan. Febuxostat Mylan treatment should not be stopped if an attack of gout occurs.For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day. Febuxostat Mylan should be started 2 days before chemotherapy and continued for at least 7 days.

How does Febuxostat Mylan work?

The active substance in Febuxostat Mylan, febuxostat, reduces the formation of uric acid. It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body. By reducing the production of uric acid, Febuxostat Mylan can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up. This can reduce the symptoms of gout. Keeping uric acid levels low for long enough can also shrink tophi. In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.

How has Febuxostat Mylan been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Adenuric, and do not need to be repeated for Febuxostat Mylan.As for every medicine, the company provided studies on the quality of Febuxostat Mylan. 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 Febuxostat Mylan?

Because Febuxostat 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 Febuxostat Mylan approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Febuxostat Mylan has been shown to have comparable quality and to be bioequivalent to Adenuric. Therefore, the CHMP's view was that, as for Adenuric, the benefit outweighs the identified risk. The Committee recommended that Febuxostat Mylan be approved for use in the EU.

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

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

---

Fendrix

What is Fendrix?

Fendrix is a vaccine, which is available as a suspension for injection. It contains parts of the hepatitis B virus as the active substance.

What is Fendrix used for?

Fendrix is used to protect patients with kidney problems against hepatitis B (a disease of the liver due to infection with the hepatitis B virus). It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique used in patients with kidney disease).The vaccine can only be obtained with a prescription.

How is Fendrix used?

The recommended vaccination schedule for Fendrix is four doses. There should be a gap of one month between the first and second, and between the second and third injections. The fourth injection is given four months after the third. It is recommended that individuals who receive the first dose should complete the course with Fendrix. The vaccine is injected into the shoulder muscle.A booster dose of Fendrix may be given, according to official recommendations.

How does Fendrix work?

Fendrix is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Fendrix contains small amounts of the 'surface antigen' (proteins from the surface) of the hepatitis B virus. When a patient is given the vaccine, the immune system recognises the surface antigens as 'foreign' and makes antibodies against them. In the future, the immune system will be able to make antibodies more quickly when it is exposed to the hepatitis B virus. The antibodies will help to protect against the disease caused by the virus.The surface antigens are produced by a method known as 'recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.The active substance in Fendrix has been available in other vaccines that have been authorised in the European Union (EU) for a number of years. In Fendrix, it is used with an 'adjuvant system' which contains 'MPL', a purified fat from bacteria, and an aluminium compound. This system enhances the response of the immune system, which can help when vaccines are used in patients who may have a lower response, such as those with kidney problems.

How has Fendrix been studied?

Because the active substance in Fendrix has been available in the EU in other vaccines, some of the information used to support the use of the other vaccines was used to support the use of Fendrix.Fendrix has also been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis. Fendrix was compared with a double dose of Engerix B (another hepatitis B vaccine). The main measure of effectiveness was the proportion of patients who developed protective levels of antibodies against the hepatitis B virus.The company also presented information on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment of the vaccine.

What benefit has Fendrix shown during the studies?

Fendrix was as effective as a double dose of the comparator vaccine. One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against the hepatitis B virus, compared with 84% of those receiving the comparator.The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.

What is the risk associated with Fendrix?

The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness). For the full list of side effects reported with Fendrix, see the package leaflet.Fendrix must not be used in people who are hypersensitive (allergic) to the active substance or any of the other ingredients or have had an allergic reaction after being given a hepatitis B vaccine. Fendrix must not be given to patients with a severe sudden fever.

Why has Fendrix been approved?

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

---

Feraccru

What is Feraccru and what is it used for?

Feraccru is an iron-containing medicine used to treat iron deficiency (lack of iron) in adults.Feraccru contains the active substance ferric maltol.

How is Feraccru used?

Feraccru is available as capsules (30 mg). The recommended dose is one capsule taken twice a day, morning and evening, on an empty stomach. Treatment duration depends on the severity of the iron deficiency, but generally at least 12 weeks of treatment are required.The medicine can only be obtained with a prescription.For more information about using Feraccru, see the package leaflet or contact your doctor or pharmacist.

How does Feraccru work?

The active substance in Feraccru, ferric maltol, is an iron-containing compound. When taken by mouth, it is absorbed by the cells of the gut; the iron is then released from the compound and transported and stored in the body, helping to restore normal levels in patients with iron deficiency. This helps correct reduced production of haemoglobin (the oxygen-carrying pigment in red blood cells), anaemia (low levels of red blood cells) and any symptoms of the condition. Iron is an essential building block for haemoglobin and the body can produce more haemoglobin and correct anaemia once iron stores are replenished.

What benefits of Feraccru have been shown in studies?

Feraccru is effective at increasing haemoglobin levels in patients with iron deficiency and anaemia, (defined as haemoglobin levels lower than 12 g/dl for women and 13 g/dl for men).In a study of 128 patients, those taking Feraccru for 12 weeks had their haemoglobin levels increase on average from 11.0 to 13.2 g/dl whereas in patients taking placebo (a dummy treatment)haemoglobin levels remained at around 11.1 g/dl. In addition, around 65% of patients taking Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.

What are the risks associated with Feraccru?

The most common side effects with Feraccru (which may affect up to 1 in 10 people) are symptoms affecting the gut such as abdominal (belly) pain, flatulence (passing wind), constipation, abdominal discomfort and distension, and diarrhoea; these side effects are usually of mild to moderate intensity. Severe side effects include abdominal pain, constipation and diarrhoea. For the full list of side effects of Feraccru, see the package leaflet.Feraccru must not be used in patients with iron overload disorder (haemachromatosis) or in patients receiving repeated blood transfusions. For the full list of restrictions, see the package leaflet.

Why is Feraccru authorised in the EU?

The European Medicines Agency decided that Feraccru's benefits are greater than its risks and it can be authorised for use in the EU. Feraccru has been shown to be effective in increasing haemoglobin levels in patients with iron deficiency anaemia. Data on how the medicine is absorbed in the body show that Feraccru can also have an effect on patients with iron deficiency who have not already developed anaemia. The safety profile of Feraccru is considered acceptable, with side effects that are mostly mild to moderate in intensity and in line with those of other iron preparations.

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

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

---

Ferriprox

What is Ferriprox and what is it used for?

Ferriprox is an 'iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major. This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.Ferriprox is used:• on its own, when standard iron chelator treatment cannot be used or does not work well enough;• in combination with another iron chelator, when treatment with one iron chelator on its own does not work or when iron levels need to be rapidly or intensively corrected to prevent or treat lifethreatening conditions (mainly affecting the heart).Ferriprox contains the active substance deferiprone.

How is Ferriprox used?

Ferriprox can only be obtained with a prescription and treatment should be started and continued by a doctor who has experience in the treatment of thalassaemia. It is available as tablets (500 and 1,000 mg) and as an oral solution (100 mg/ml).The usual dose of Ferriprox is 25 mg per kilogram body weight three times a day. The doctor may adjust the dose of Ferriprox according to how well the patient's iron levels are being controlled, which should be measured every 2 to 3 months with blood tests. The total dose for the whole day should be less than 100 mg per kilogram body weight. The doctor may interrupt treatment if iron levels get too low.For more information about using Ferriprox, see the package leaflet or contact your doctor or pharmacist.

How does Ferriprox work?

Patients with thalassaemia major need frequent blood transfusions. Transfused red cells bring iron into the body. With repeated transfusions, the iron builds up because the body does not have a natural wayof removing excess iron. Over time, the excess iron can damage important organs such as the heart and liver. The active substance in Ferriprox, deferiprone, is an iron chelator. It attaches to iron in the body to form a compound that can be removed from the body, mainly in the urine, and to a lesser extent in the stools. Removing iron in this way helps to correct the iron overload and prevent damage from excess iron.

What benefits of Ferriprox have been shown in studies?

Ferriprox was studied in 247 patients with thalassaemia major, aged over 6 years. The main measure of effectiveness was the change in the levels of ferritin in the blood. The blood ferritin level indicates how much iron is being stored in the body.The main study involving 71 patients compared Ferriprox with deferoxamine, another iron chelator, over 2 years. Deferoxamine was given by injection under the skin overnight. The average blood ferritin levels were similar in the two treatment groups. However, the average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.In another study involving 60 patients treated over 12 months, a combination of Ferriprox and deferoxamine (Ferriprox for 5 days plus deferoxamine for 2 days each week) was compared with deferoxamine on its own. Blood ferritin levels were reduced to the same extent in patients treated with the combination as with deferoxamine on its own. There were too few patients in the study to prove whether such a schedule is as effective as deferoxamine on its own.In addition, published studies on Ferriprox together with deferoxamine reported greater reductions in blood ferritin levels when both medicines were used in combination compared with using either medicine on its own. In a published study, Ferriprox together with deferoxamine also led to greater decreases in iron in the heart compared with patients taking deferoxamine alone.

What are the risks associated with Ferriprox?

The most common side effects with Ferriprox (which may affect more than 1 in 10 people) are redbrown urine (showing that iron is being removed through the urine), nausea (feeling sick), abdominal pain (stomach ache) and vomiting. Less common but more serious side effects are agranulocytosis (very low levels of granulocytes, a type of white blood cell) and neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).Ferriprox must not be used in people who have had neutropenia repeatedly or agranulocytosis. Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis. When taking Ferriprox, the patient's neutrophil count should be checked regularly (every week in the first year then less frequently). If the patient gets an infection, treatment with Ferriprox should be temporarily stopped and the neutrophil count checked more often. Patients should tell their doctor immediately if they have symptoms of an infection, such as fever, sore throat and flu-like symptoms.Ferriprox must not be used in women who are pregnant or breastfeeding.For the full list of restrictions and side effects of Ferriprox, see the package leaflet.

Why is Ferriprox authorised in the EU?

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

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

The company that markets Ferriprox must supply a reminder card for patients or their carers about the importance of regular tests for neutrophil counts, the need to watch out for symptoms of infection and for women to avoid becoming pregnant during treatment with Ferriprox.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ferriprox have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Ferriprox are continuously monitored. Side effects reported with Ferriprox are carefully evaluated and any necessary action taken to protect patients.

---

Fetcroja

What is Fetcroja and what is it used for?

Fetcroja is an antibiotic used in adults to treat infections caused by bacteria classed as aerobic Gramnegative bacteria. It is for use when other treatments might not work.Fetcroja contains the active substance cefiderocol.

How is Fetcroja used?

Fetcroja can only be obtained with a prescription. It should only be used after taking advice from a doctor with appropriate experience of managing patients with infectious diseases.Fetcroja is given by infusion (drip) into a vein over 3 hours. The usual dose is 2 g given every 8 hours and the duration of treatment depends on the nature of the infection.For more information about using Fetcroja, see the package leaflet or contact your doctor or pharmacist.

How does Fetcroja work?

The active substance in Fetcroja, cefiderocol, belongs to the cephalosporin class of antibiotics. It uses the bacteria's own system for importing iron to enter the bacterial cell, where it blocks the formation of the bacterial cell wall, killing the bacteria.

What benefits of Fetcroja have been shown in studies?

Fetcroja was tested in 2 main studies involving patients with various infections caused by Gramnegative bacteria.In the first study, involving 452 adults with complicated urinary tract infection, 73% of patients treated with Fetcroja were cured (based on lack of symptoms and tests for bacteria in the urine) compared with 55% of patients treated with imipenem and cilastatin given together.The second study involved 152 adults with various serious infections caused by bacteria that were resistant to carbapenems (could not be killed by antibiotics called carbapenems). For lung infections, 50% of patients treated with Fetcroja were cured based on a lack of symptoms, compared with 53% ofthose treated with the best alternative treatment. For bloodstream infections, these figures were 44% and 43%, respectively. For complicated urinary tract infections, 53% of patients treated with Fetcroja were cleared of disease-causing bacteria in the urine compared with 20% of patients receiving the best alternative treatment.

What are the risks associated with Fetcroja?

The most common side effects (which may affect up to 1 in 10 people) were diarrhoea, vomiting, nausea (feeling sick) and cough. For the full list of side effects with Fetcroja, see the package leaflet.Fetcroja must not be used in patients who are hypersensitive (allergic) to any cephalosporin antibiotic or who have had a severe reaction to the broader class of beta-lactam antibiotics (such as penicillins or carbapenems). For the full list of restrictions, see the package leaflet.

Why is Fetcroja authorised in the EU?

The European Medicines Agency noted that the number of patients in the main studies was small. However, taken together with laboratory studies and studies on how the medicine works in the body, there was sufficient evidence that Fetcroja is effective against infections caused by aerobic Gram- negative bacteria. The Agency therefore decided that Fetcroja'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 Fetcroja?

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

---

Fiasp

What is Fiasp and what is it used for?

Fiasp is a medicine that is used to treat children from one year of age and adults with diabetes. It contains the active substance insulin aspart, a rapid-acting insulin.

How is Fiasp used?

Fiasp is a solution for injection available in vials, cartridges or pre-filled pens and can only be obtained with a prescription. It is usually injected under the skin of the belly or upper arm immediately before a meal, although it may be given up to 20 minutes after starting a meal if necessary. The dose depends on the patient's blood glucose, which should be tested regularly to find the dose that gives good control of blood sugar. When injected under the skin, Fiasp should be used in combination with an intermediate- or long-acting insulin that is given at least once a day.Fiasp can also be used in a pump system for continuous insulin infusion under the skin or alternatively, it can be injected into a vein but only by a doctor or a nurse.For more information about using Fiasp, see the package leaflet or contact your doctor or pharmacist.

How does Fiasp work?

Diabetes is a disease in which blood glucose 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). The replacement insulin in Fiasp acts in the same way as the body's own insulin and helps glucose enter cells from the blood. This controls the level of blood glucose and reduces the symptoms and complications of diabetes. Insulin aspart enters the bloodstream faster than human insulin after injection and therefore works more quickly.

What benefits of Fiasp have been shown in studies?

The benefits of Fiasp in reducing blood glucose as part of diabetes treatment have been shown in 4 main studies.In two studies Fiasp was at least as effective as another insulin, NovoRapid. Both Fiasp and NovoRapid contain insulin aspart but Fiasp contains some different ingredients intended to help it to be absorbed rapidly. The main measure of effectiveness was the medicine's ability to decrease the level in the blood of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled over time. One study involving 1,143 adults with type 1 diabetes whose starting HbA1c was around 7.6% found that after 6 months of treatment HbA1c fell by 0.32 percentage points with a mealtime dose of Fiasp, compared with 0.17 points with the other insulin. In the second study involving 689 adults with type 2 diabetes, the fall after 6 months of treatment (from a starting value of 7.96% and7.89% respectively) was 1.38 points with Fiasp and 1.36 points with the comparator.A third study involving 236 adults with type 2 diabetes and a starting HbA1c of around 7.9% found that adding mealtime Fiasp to treatment with a long-acting insulin and the diabetes medicine metformin improved blood glucose control. (There was no direct comparison between Fiasp and another mealtime insulin in this study.) In patients given Fiasp the HbA1c fell after 18 weeks by 1.16 percentage points, compared with 0.22 points in those on long-acting insulin and metformin alone.A fourth study in 777 adolescents and children from 2 years of age with type 1 diabetes and a starting HbA1c of around 7.6% compared Fiasp (given at mealtime or 20 minutes after the start of the meal) with NovoRapid (given at mealtime). In this study, Fiasp was at least as effective as the comparator: there was almost no change in HbA1c in patients given Fiasp at mealtime (0.05 percentage points) and a similar slight increase in those given Fiasp after a meal or NovoRapid at mealtime (0.35 and 0.23 percentage points respectively).

What are the risks associated with Fiasp?

The most common side effect with Fiasp (which may affect more than 1 in 10 people) is hypoglycaemia (excessively low blood sugar). Hypoglycaemia can occur more quickly with Fiasp than with other mealtime insulins. For the full list of side effects and restrictions of Fiasp, see the package leaflet.

Why is Fiasp authorised in the EU?

A clinically relevant benefit in lowering blood glucose has been shown in studies with Fiasp.Compared with the already authorised insulin aspart medicine NovoRapid, the lowering of blood glucose develops earlier in adults given Fiasp, although the total extent of the lowering effect is similar. However, it is unclear whether this changes the risk of diabetic complications. The overall rate and severity of side effects was comparable with NovoRapid, although hypoglycaemia occurred more often in the first 2 hours after a dose of Fiasp. The benefits of Fiasp were also shown in children. Although Fiasp was not studied in children below 2 years of age, it is also expected to have a beneficial effect in younger children. The slightly higher risk of hypoglycaemia at night in children treated with Fiasp is addressed in the product information and is considered manageable.The European Medicines Agency therefore decided that Fiasp's benefits 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 Fiasp?

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

---

Filgrastim Hexal

What is Filgrastim Hexal?

Filgrastim Hexal is a solution for injection or infusion (drip into a vein) in a pre-filled syringe. It contains the active substance filgrastim (30 or 48 million units).Filgrastim Hexal is a 'biosimilar' medicine. This means that Filgrastim Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the 'reference medicine'). The reference medicine for Filgrastim Hexal is Neupogen. For more information on biosimilar medicines, see the question-and-answer document here.

What is Filgrastim Hexal used for?

Filgrastim Hexal is used to stimulate the production of white blood cells in the following situations:• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);• to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;• to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;•Filgrastim Hexal can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.The medicine can only be obtained with a prescription.

How is Filgrastim Hexal used?

Filgrastim Hexal is given by injection under the skin or infusion into a vein. How it is given, the dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment. Filgrastim Hexal is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately. For more information, see the package leaflet.

How does Filgrastim Hexal work?

The active substance in Filgrastim Hexal, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF). Filgrastim is produced by a method known as 'recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce filgrastim. The replacement acts in the same way as naturally produced G CSF by encouraging the bone marrow to produce more white blood cells.

How has Filgrastim Hexal been studied?

Filgrastim Hexal was studied to show that it is comparable to the reference medicine, Neupogen.Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Filgrastim Hexal or Neupogen. The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein. The main measure in these studies was the neutrophil count over the first 10 days of treatment.

What benefit has Filgrastim Hexal shown during the studies?

Filgrastim Hexal and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies. This was considered sufficient to demonstrate that the benefits of Filgrastim Hexal are comparable to those of the reference medicine.

What is the risk associated with Filgrastim Hexal?

The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim Hexal is being used for. For the full list of all side effects and restrictions, see the package leaflet.

Why has Filgrastim Hexal been approved?

The CHMP decided that, in accordance with EU requirements, Filgrastim Hexal has been shown to have a comparable quality, safety and efficacy profile to Neupogen. Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk. The Committee recommended that Filgrastim Hexal be given marketing authorisation.

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

A risk management plan has been developed to ensure that Filgrastim Hexal 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 Filgrastim Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.

---

Filsuvez

What is Filsuvez and what is it used for?

Filsuvez is a medicine that is used in adults and children aged 6 months or older with epidermolysis bullosa (EB).EB is an inherited disease of the skin that makes the skin very fragile and causes severe blistering and scarring. Filsuvez is used in two types of EB, dystrophic EB and junctional EB, to treat partial-thickness skin wounds. These are wounds where the upper layers of the skin have been damaged.EB is rare, and Filsuvez was designated an 'orphan medicine' (a medicine used in rare diseases) on 23 February 2011. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu-310845Filsuvez contains a dry extract from two species of birch bark consisting of naturally occurring substances known as triterpenes, including betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid.

How is Filsuvez used?

Filsuvez is available as a gel that should be applied to the wound surface at a thickness of approximately 1 mm and covered by a wound dressing. The medicine can also be applied directly to the wound dressing. The gel should not be applied sparingly, and should be re-applied with every dressing change until the wound has healed. If symptoms do not improve after use or if wound complications occur, your healthcare professional will assess your condition and consider whether to continue treatment.For more information about using Filsuvez, see the package leaflet or contact your doctor, nurse or pharmacist.The medicine can only be obtained with a prescription.

How does Filsuvez work?

The exact way Filsuvez works is not fully understood. It is thought that the active substance in Filsuvez, birch bark extract, may help the cells that make up the outer layer of the skin (keratinocytes) grow and move towards the gap created by the wound, thereby helping wounds to heal.

What benefits of Filsuvez have been shown in studies?

The effectiveness of Filsuvez at treating partial-thickness wounds was investigated in one main study involving 223 adults and children with EB, including dystrophic and junctional subtypes. Of those who were treated with Filsuvez in combination with wound dressing, 41% showed complete closure of the wound within 45 days, compared with 29% who were using a control gel (a dummy treatment) in combination with wound dressing. No difference from the control gel was noted after 90 days.

What are the risks associated with Filsuvez?

The most common side effects with Filsuvez (which may affect more than 1 in 10 people) are wound complications. Other common side effects include skin reactions at the application site, wound infections, pruritis (itching), and hypersensitivity (allergic) reactions (may occur in more than 1 in 100 people).For the full list of side effects of Filsuvez, see the package leaflet.

Why is Filsuvez authorised in the EU?

Filsuvez gel was shown to be effective for patients with dystrophic and junctional EB at treating partialthickness wounds, which can be difficult to heal, leading to pain and a risk of infection, and for which treatment options are limited. Although effects were modest, they were considered clinically meaningful for EB patients with dystrophic and junctional EB and the medicine had an acceptable safety profile, with side effects that were localised and manageable. Therefore, the European Medicines Agency decided that the benefits of Filsuvez 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 Filsuvez?

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

---

Fingolimod Accord

What is Fingolimod Accord and what is it used for?

Fingolimod Accord is a type of medicine known as a 'disease-modifying therapy' that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (RRMS). 'Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods with milder or no symptoms (remissions). Fingolimod Accord is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.Fingolimod Accord is a 'generic medicine'. This means that Fingolimod Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Gilenya. For more information on generic medicines, see the question-and-answer document here.Fingolimod Accord contains the active substance fingolimod.

How is Fingolimod Accord used?

Fingolimod Accord can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis. Fingolimod Accord is available as capsules (0.5 mg). The recommended dose for adults is one capsule taken once a day by mouth, the recommended dose for children depends on body weight.Because Fingolimod Accord decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity are checked before starting treatment and during treatment, and also if Fingolimod Accord treatment is restarted after an interruption. Details on the recommendations for monitoring patients are found in the summary of product characteristics.For more information about using Fingolimod Accord, see the package leaflet or contact your doctor or pharmacist.

How does Fingolimod Accord work?

In multiple sclerosis, the immune system (the body's defences) attacks and damages the protective insulation around the nerves and the nerves themselves in the brain and spinal cord.SendThe active substance in Fingolimod Accord, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis. It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1- phosphate receptor, which is involved in controlling the movement of these cells in the body.

How has Fingolimod Accord 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, Gilenya, and do not need to be repeated for Fingolimod Accord.As for every medicine, the company provided studies on the quality of Fingolimod 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 Fingolimod Accord?

Because Fingolimod 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 Fingolimod Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, FingolimodAccord has been shown to have comparable quality and to be bioequivalent to Gilenya. Therefore, the Agency's view was that, as for Gilenya, the benefits of Fingolimod 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 Fingolimod Accord?

The company that markets Fingolimod Accord must ensure that all doctors who prescribe the medicine receive an information pack containing important safety information, including a checklist of the risks with Fingolimod Accord and the situations where its use is not recommended. The checklist includes information on the tests and monitoring in patients before and during treatment with Fingolimod Accord. The pack will also include a reminder card for patients or their carers with key safety information about Fingolimod Accord, and a pregnancy-specific card to remind patients that Fingolimod Accord must not be used during pregnancy and in women who can become pregnant and are not using effective contraception.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fingolimod Accord have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Fingolimod Accord are continuously monitored. Side effects reported with Fingolimod Accord are carefully evaluated and any necessary action taken to protect patients.

---

Fingolimod Mylan

What is Fingolimod Mylan and what is it used for?

Fingolimod Mylan is a medicine used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (RRMS). 'Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods with milder or no symptoms (remissions). Fingolimod Mylan is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.Fingolimod Mylan contains the active substance fingolimod and is a 'generic medicine'. This means that Fingolimod Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Gilenya. For more information on generic medicines, see the question-and-answer document here.

How is Fingolimod Mylan used?

Fingolimod Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis. Fingolimod Mylan is available as capsules (0.5 mg). The recommended dose for adults is one capsule taken once a day by mouth, the recommended dose for children depends on body weight.For more information about using Fingolimod Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Fingolimod Mylan work?

In multiple sclerosis, the immune system (the body's natural defenses) attacks and damages the protective insulation around the nerves and the nerves themselves in the brain and spinal cord. The active substance in Fingolimod Mylan, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis. It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1-phosphate receptor, which is involved in controlling the movement of these cells in the body.Send

How has Fingolimod 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, Gilenya, and do not need to be repeated for Fingolimod Mylan.As for every medicine, the company provided data on the quality of Fingolimod Mylan. 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 Fingolimod Mylan?

Because Fingolimod 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 Fingolimod Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Fingolimod Mylan has been shown to have comparable quality and to be bioequivalent to Gilenya. Therefore, the Agency's view was that, as for Gilenya, the benefits of Fingolimod 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 Fingolimod Mylan?

The company that markets Fingolimod Mylan must ensure that all doctors who prescribe the medicine receive an information pack containing important safety information, including a checklist of the risks with Fingolimod Mylan and the situations where its use is not recommended. The checklist includes information on the tests and monitoring in patients before and during treatment with Fingolimod Mylan. The pack will also include a reminder card for patients or their carers with key safety information about Fingolimod Mylan, and a pregnancy-specific card to remind patients that Fingolimod Mylan must not be used during pregnancy and in women who can become pregnant and are not using effective contraception.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fingolimod Mylan have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Fingolimod Mylan are continuously monitored. Suspected side effects reported with Fingolimod Mylan are carefully evaluated and any necessary action taken to protect patients.

---

Fintepla

What is Fintepla and what is it used for?

Fintepla is a medicine used in addition to other epilepsy medicines to treat patients from 2 years of age who have Dravet syndrome or Lennox-Gastaut syndrome, types of epilepsy that begin in childhood and continue into adulthood.These conditions are rare, and Fintepla was designated an 'orphan medicine' (a medicine used in rare diseases). Further information on the orphan designations can be found on the Agency's website (Dravet syndrome: 18 December 2013; Lennox-Gastaut syndrome: 27 February 2017).Fintepla contains the active substance fenfluramine.

How is Fintepla used?

The medicine can only be obtained by 'special' prescription. This means that it is used under stricter conditions than normal to prevent misuse and to ensure doctors are informed about the need for regular heart checks in patients taking the medicine. Treatment should be started and supervised by a doctor experienced in the treatment of epilepsy.Fintepla is available as a liquid to be taken by mouth twice a day. The dose depends on the patient's weight and, for Dravet syndrome, whether the patient is taking another epilepsy medicine called stiripentol. The dose can be adjusted based on the response to treatment.For more information about using Fintepla, see the package leaflet or contact your doctor or pharmacist.

How does Fintepla work?

The active substance in Fintepla, fenfluramine, causes the release of serotonin in the brain. Serotonin is a substance used by nerve cells to communicate with neighbouring cells. The exact way that fenfluramine works is not fully understood. It is thought that serotonin acts on several targets in the brain to improve symptoms of patients with Dravet syndrome or Lennox-Gastaut syndrome.Fenfluramine may also protect against seizures by acting on the sigma-1 receptor found on the surface of nerve cells.

What benefits of Fintepla have been shown in studies?

Studies showed that Fintepla reduces the frequency of seizures in children and young adults withDravet syndrome or Lennox-Gastaut syndrome who are taking at least one other epilepsy medicine.Two main studies involving a total of 205 patients with Dravet syndrome compared Fintepla with placebo (a dummy treatment), both given in addition to the patient's standard of care.In the first study, the average (median) monthly number of seizures reduced from 21 to 5 in patients treated with Fintepla, and from 34 to 26 in those taking placebo. The study also showed that 73% of patients treated with Fintepla and 10% of those taking placebo had at least a 50% reduction in the monthly number of seizures.In the second study, patients were also taking stiripentol and at least one other epilepsy medicine. The average (median) monthly number of seizures reduced from 14 to 4 in patients treated with Fintepla and remained at 11 in patients taking placebo. In this study, 55% of patients treated with Fintepla and 9% of those taking placebo had at least a 50% reduction in the monthly number of seizures.A third main study involving 263 patients with Lennox-Gastaut syndrome compared Fintepla with placebo, both given in addition to the patient's standard of care. The main measure of effectiveness was the change in the frequency of drop seizures (brief loss of muscle tone and reduced consciousness, causing abrupt falls). The study found that the average (median) frequency of drop seizures reduced by 26.5% in the 87 patients receiving Fintepla compared with 7.6% in those receiving placebo (87 patients). The study also showed that the monthly number of drop seizures fell by at least half in 25% of patients treated with Fintepla and 10% of those taking placebo.

What are the risks associated with Fintepla?

In patients with Lennox-Gastaut syndrome, the most common side effects with Fintepla (which may affect more than 1 in 10 people) are decreased appetite, tiredness, somnolence (sleepiness), vomiting and diarrhoea.In patients with Dravet syndrome, the most common side effects with Fintepla are decreased appetite, diarrhoea, fever, tiredness, upper respiratory tract infection (nose and throat infection), lethargy (lack of energy), somnolence and bronchitis (chest infection).For the full list of side effects of Fintepla, see the package leaflet.Fintepla must not be taken by patients who have heart or lung problems called valvular heart disease or pulmonary hypertension. It must also not be used by patients who have used medicines called monoamine oxidase inhibitors (MAOI), including MAOI antidepressants, in the last 2 weeks.For the full list of restrictions, see the package leaflet.

Why is Fintepla authorised in the EU?

Dravet syndrome and Lennox-Gastaut syndrome are rare diseases with limited treatment options. Fintepla used in addition to other epilepsy medicines has been shown to reduce the frequency of seizures in children and young adults with these diseases. The side effects are considered manageable with the measures described below in place to prevent the risks.The European Medicines Agency therefore decided that Fintepla'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 Fintepla?

Serious cases of heart and lung problems (valvular heart disease and pulmonary arterial hypertension) have been reported with higher doses of the medicine used in the past for the treatment of obesity in adults. Although these effects have not been reported at the lower doses used in patients with Dravet syndrome or Lennox-Gastaut syndrome, several measures have been put in place to minimise this risk:• The company that markets Fintepla will ensure that a system is put in place to control access to the medicine and prevent misuse. Doctors who are expected to prescribe this medicine will receive educational material with information about monitoring patients' heart function and minimising misuse of the medicine.• The company that markets Fintepla will also provide doctors with educational materials to give to patients to inform them about the need for heart monitoring and how to detect and manage heart and lung problems, should they occur.• The company will set up a registry to collect data on the long-term safety of Fintepla and to assess whether the measures to minimise the risk of serious side effects have worked.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fintepla have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Fintepla are continuously monitored. Side effects reported with Fintepla are carefully evaluated and any necessary action taken to protect patients.

---

Firazyr

What is Firazyr and what is it used for?

Firazyr is a medicine used to treat the symptoms of attacks of hereditary angioedema in adults, adolescents and children aged over 2 years. Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. Attacks of hereditary angioedema can be life threatening when they involve the throat. Firazyr is used in patients whose angioedema is linked to naturally low levels of a protein called 'C1 esterase inhibitor'.Firazyr contains the active substance icatibant.Because the number of patients with angioedema is low, the disease is considered 'rare', and Firazyr was designated an 'orphan medicine' (a medicine used in rare diseases) on 17 February 2003.

How is Firazyr used?

Each pre-filled syringe of Firazyr contains 30 mg icatibant in 3 ml. The medicine is given by injecting it slowly under the skin, preferably in the abdomen (belly). The recommended dose of Firazyr in adults is one injection (3 ml). If symptoms continue or come back, a second injection can be given after 6 hours. If needed, treatment can be repeated for a third time after an additional 6 hours. No more than three injections should be given in any 24-hour period.The dose for adolescents and children depends on their body weight.The doctor may decide that the patient or their caregiver can inject the medicine themselves, after they have been properly trained by a healthcare professional.Firazyr can only be obtained with a prescription. For further information, see the package leaflet.

How does Firazyr work?

Patients with hereditary angioedema have high levels of a substance called 'bradykinin', which is involved in causing inflammation and swelling. The active substance in Firazyr, icatibant, blocks the receptors that bradykinin normally attaches to. This blocks the activity of bradykinin, helping to relieve the symptoms of the disease.

What benefits of Firazyr have been shown in studies?

Firazyr was found effective in two main studies in adults with hereditary angioedema involving the skin or the abdomen. The main measure of effectiveness was how long it took for the patient's symptoms to be relieved. In both studies, the time it took for symptoms to improve was shorter for patients taking Firazyr than the comparator medicine.The first study compared Firazyr with tranexamic acid (another medicine for hereditary angioedema) in 74 patients, and the second study compared Firazyr with placebo (a dummy treatment) in 56 patients. Patients' symptoms were relieved on average 2 to 2.5 hours after receiving Firazyr, compared with 12 hours for tranexamic acid in one study and 4.6 hours for placebo in the other study. Firazyr was also found effective among patients included in the two studies who had attacks of angioedema that affected the throat.In another study involving 22 adolescents and children aged over 2 years with hereditary angioedema, symptoms improved on average 1 hour after the patients received Firazyr.

What are the risks associated with Firazyr?

The most common side effects with Firazyr (seen in more than 1 patient in 10) are injection site reactions including erythema (redness), swelling, burning, itching and pain at injection sites.For the list of all side effects and restrictions with Firazyr, see the package leaflet.

Why is Firazyr approved?

The European Medicines Agency decided that Firazyr's benefits are greater than its risks and recommended that it be given marketing authorisation.Firazyr was found to relieve swelling in the skin and abdomen, as well as swelling of the throat. It works in a different way to other authorised treatments.

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

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

---

Firdapse

What is Firdapse?

Firdapse is a medicine that contains the active substance amifampridine. It is available as tablets (10 mg).

What is Firdapse used for?

Firdapse is used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a disease in which patients have muscle weakness because of a failure of the nerves to transmit electrical impulses to the muscles.Because the number of patients with LEMS is low, the disease is considered 'rare', and Firdapse was designated an 'orphan medicine' (a medicine used in rare diseases) on 18 December 2002.The medicine can only be obtained with a prescription.

How is Firdapse used?

Treatment with Firdapse should only be started under the supervision of a doctor experienced in treating LEMS.1 Previously known as Zenas.The recommended starting dose of Firdapse is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day. Firdapse is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Firdapse should be taken with food.

How does Firdapse work?

For muscles to contract, nerves have to transmit electrical impulses to the muscles through a chemical messenger called acetylcholine. Acetylcholine is released from the nerve endings during a period of 'depolarisation'.The active substance in Firdapse, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells. This prolongs the period of depolarisation, allowing more time for the nerves to release acetylcholine and so stimulate the muscles to contract.

How has Firdapse been studied?

Because amifampridine-containing medicines have been used in the European Union (EU) for over 20 years, the company presented the results of studies from the scientific literature on amifampridine to support the use of Firdapse. In two published studies involving a total of 38 adults with LEMS, amifampridine was compared with placebo (a dummy treatment). The main measures of effectiveness were based on the rating of how well the muscles worked using a scoring system, either the neurological disability score (NDS) or the quantitative myasthenia gravis (QMG) score. Patients with lower NDS or QMG scores have better muscle function. Another study combined data from the two published studies and looked at compound muscle action potential (CMAP). CMAP is a measure of electrical activity in muscles. Additionally, the effect of Firdapse on the QT interval (the electrical activity of the heart) was investigated.

What benefit has Firdapse shown during the studies?

Firdapse was more effective than placebo at treating patients with LEMS. In one study, the NDS was reduced from 40 to 22 points in patients taking Firdapse compared with a drop to 35 points in patients taking placebo. The other study showed a reduction in the QMG score of 2 points in patients taking Firdapse compared with a rise of 0.25 points in patients taking placebo. In the third combined study, patients taking Firdapse had better improvements in CMAP than patients taking placebo. In the QT study, amifampridine was observed to have no effects on the activity of the heart, as shown by the electrocardiograms of healthy volunteers taking part in this study.

What is the risk associated with Firdapse?

The most common side effects reported with Firdapse are paraesthesia (unusual sensations like pins and needles) and gastro-intestinal disorders such as epigastralgia (pain around the upper part of the stomach), diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).Firdapse must not be used in patients who have epilepsy or in patients with uncontrolled asthma or congenital QT syndromes (disruption of the heartbeat). It must not be used with sultopride (an antipsychotic medicine), or medicines known to cause QTc prolongation (an alteration of the electrical activity of the heart). It must also not be used with medicines that have a narrow therapeutic window. A medicine with a narrow therapeutic window can easily cause side effects if given at a dose a little higher than the recommended dose.For the full list of all side effects and restrictions with Firdapse, see the package leaflet.

Why has Firdapse been approved?

The CHMP decided that Firdapse's benefits are greater than its risks and recommended that it be given marketing authorisation.Firdapse has been authorised under 'exceptional circumstances'. This means that because the disease is rare, it has not been possible to obtain complete information about Firdapse. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Firdapse?

The company that makes Firdapse will provide further data from studies on cancer in experimental models.

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

A risk management plan has been developed to ensure that Firdapse 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 Firdapse, including the appropriate precautions to be followed by healthcare professionals and patients.Additionally, the company that markets Firdapse has been required to set up a patient registry for patients with LEMS. The company will ensure that all healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.

---

Firmagon

What is Firmagon and what is it used for?

Firmagon is a medicine used to treat cancer of the prostate (a gland of the male reproductive system) in adult men when the cancer is 'hormone-dependent', which means that it responds to treatments that reduce the levels of the hormone testosterone. It is used:• to treat advanced hormone-dependent prostate cancer. 'Advanced' means that the cancer has spread beyond the pelvis to nearby tissues such as lymph nodes and bone;• before or together with radiotherapy to treat high-risk localised or locally advanced hormonedependent prostate cancer. 'High-risk localised' means that the cancer is likely to spread beyond the prostate gland to nearby tissues and become 'locally advanced'.Firmagon contains the active substance degarelix.

How is Firmagon used?

Firmagon is injected under the skin of the abdomen. Treatment starts with two 120-mg injections, followed by single 80-mg injections every month. Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA). PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer.The medicine can only be obtained with a prescription. For more information about using Firmagon, see the package leaflet or contact your doctor or pharmacist.

How does Firmagon work?

Testosterone can make prostate cancer cells grow. The active substance in Firmagon, degarelix, reduces the amount of testosterone in the body by blocking the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH). GnRH is the first step in a system responsible for testosterone production. By blocking GnRH, Firmagon slows down the growth of the cancer cells. Wheninjected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.

What benefits of Firmagon have been shown in studies?

A main study involving 610 men with prostate cancer at all stages of the disease showed that Firmagon is effective at reducing the amount of testosterone to levels seen in men whose testicles have been surgically removed.In this study, Firmagon was as effective as leuprorelin (another medicine for prostate cancer). During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level. This was compared with 96% of patients receiving leuprorelin.A second study involving 244 men with intermediate- to high-risk prostate cancer found that Firmagon was as effective at reducing the prostate volume before radiotherapy as a combination of two other prostate cancer medicines, goserelin and bicalutamide. After 12 weeks of treatment, prostate volume decreased by 36.0% in patients treated with Firmagon and 35.3% in those receiving goserelin and bicalutamide.

What are the risks associated with Firmagon?

The most common side effects with Firmagon (which may affect more than 1 in 10 people) are hot flushes and reactions at the injection site such as pain and redness.For the full list of side effects and restrictions of Firmagon, see the package leaflet.

Why is Firmagon authorised in the EU?

The European Medicines Agency decided that Firmagon's benefits are greater than its risks and it can be authorised for use in the EU.Firmagon was as effective as leuprorelin in the treatment of advanced hormone-dependent prostate cancer. In addition, Firmagon was also effective for high-risk localised or locally advanced prostate cancer before radiotherapy. Based on its mechanism of action, the Agency considered that Firmagon can also be expected to be effective for high-risk localised or locally advanced prostate cancer in combination with radiotherapy. This will be further confirmed in an ongoing study.The agency also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with 'GnRH agonists' (other medicines for prostate cancer that stimulate the production of GnRH). This means that patients do not need to take other medicines to block testosterone at the start of treatment.

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

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

---

Flebogamma Dif

What is Flebogamma DIF?

Flebogamma DIF is a solution for infusion (drip into a vein). It contains the active substance human normal immunoglobulin.

What is Flebogamma DIF used for?

Flebogamma DIF is used in patients who need more antibodies in their blood to help fight infections and other diseases. It is used to treat the following conditions:• Primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies).• Hypogammaglobulinaemia (low levels of antibodies) in patients:
-with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) and frequent bacterial infections after preventive treatment with antibiotics has failed;
-with multiple myeloma (another cancer of a type of white blood cell) and frequent bacterial infections and in whom vaccination against 'pneumococcal' bacteria has failed;
- who have had haematopoietic (blood) stem cell transplantation (when the patient receives stem cells from a matched donor to help restore the bone marrow).
• Acquired immune deficiency syndrome (AIDS) in children who contracted HIV from birth and have frequent infections.Flebogamma DIF is also used to treat certain immune system disorders:• Idiopathic thrombocytopenic purpura (ITP), a condition where people do not have enough platelets in the blood;• Guillain-Barrι syndrome, which causes multiple inflammations of the nerves in the body;• Kawasaki disease, which causes multiple inflammations of several organs in the body.The medicine can only be obtained with a prescription.

How is Flebogamma DIF used?

Flebogamma DIF is given by infusion into a vein by a doctor or nurse, but patients (or their carers) may administer it themselves once they have been trained. The dose and frequency of infusion depend on the disease being treated, and may need to be adjusted for patients depending on their response.For full details, see the summary of product characteristics (also part of the EPAR).

How does Flebogamma DIF work?

The active substance in Flebogamma DIF, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood). It contains immunoglobulin G (IgG), which is a type of antibody. IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection. Flebogamma DIF works by restoring abnormally low IgG levels to their normal range in the blood. At higher doses, it can help to adjust an abnormal immune system and modulate the immune response.Flebogamma DIF is made like Flebogamma, another medicine containing human normal immunoglobulin, with some additional steps in the purification of the product from human plasma.

How has Flebogamma DIF been studied?

As human normal immunoglobulin has been used to treat these diseases for some time, only two small studies were needed to establish the effectiveness and safety of Flebogamma DIF in patients.In the first study, involving 46 patients with PID, the medicine was infused every 21 to 28 days. The main measure of effectiveness was the number of serious bacterial infections over a year's treatment.The second study looked at using Flebogamma DIF in 20 patients with ITP. The main measure of effectiveness was the highest blood platelet level that was achieved during the three-month study.Flebogamma DIF was not compared with any other treatment in either study.

What benefit has Flebogamma DIF shown during the studies?

In the first study, the patients had an average of 0.021 serious infections per year. Since this is below the predefined threshold of one infection per year, this indicates that the medicine is effective in replacing the patient's antibodies.In the second study, up to 14 (73%) of the 19 patients who remained in the study had a platelet count above 50 million platelets per millilitre at least once during the study.Flebogamma DIFF

What is the risk associated with Flebogamma DIF?

Side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia(joint pain), low blood pressure and moderate low back pain may occasionally occur withFlebogamma DIF. Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in a few cases, anaphylactic shock (a severe allergic reaction) even when the patient had no previous allergic reaction to the medicine.Flebogamma DIF must not be used in people who are allergic to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulin, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA. The medicine must not be used in patients who are intolerant to fructose (a type of sugar). In babies and young children, hereditary fructose intolerance may not yet have been diagnosed and may be fatal; this medicine must therefore not be given to babies and children below two years of age.

Why has Flebogamma DIF been approved?

According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children. They can also be approved for the treatment of patients with Guillain-Barrι syndrome, patients with Kawasaki disease and patients undergoing haematopoietic stem cell transplantation, without the need for specific studies in these diseases.Therefore, the CHMP concluded that Flebogamma DIF's benefits are greater than its risks and recommended that it be given marketing authorisation.

---

Flixabi

What is Flixabi and what is it used for?

Flixabi is an anti-inflammatory medicine. It is used in adults, usually when other medicines or treatments have failed or cannot be used, for the treatment of the following diseases:• rheumatoid arthritis (an immune-system disease causing inflammation of the joints). Flixabi is used with methotrexate (a medicine that acts on the immune system);• Crohn's disease (a disease causing inflammation of the gut), when the disease is moderate to severe or causes fistulae (abnormal passageways between the gut and other organs);• ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);• ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine); •• psoriasis (a disease causing red, scaly patches on the skin).Flixabi is also used in patients aged between 6 and 17 years with severe Crohn's disease or ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.For further information see the summary of product characteristics (also part of the EPAR).Flixabi contains the active substance infliximab and is a 'biosimilar medicine'. This means that Flixabi is similar to a biological medicine (also known as the 'reference medicine') that is already authorised in the European Union (EU). The reference medicine for Flixabi is Remicade. For more information on biosimilar medicines, see the question-and-answer document here.

How is Flixabi used?

Flixabi treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Flixabi is used to treat. The medicine can only be obtained with a prescription.Flixabi is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary. The dose is 5 mg per kilogram for the other diseases. How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine.Flixabi is given as an infusion lasting one or two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Flixabi or the infusion time may be slowed down. For further information, see the package leaflet.

How does Flixabi work?

The active substance in Flixabi, infliximab, is a monoclonal antibody (a type of protein) that has been designed to attach to a protein called tumour necrosis factor-alpha (TNF-alpha) and block its activity. TNF-alpha is involved in causing inflammation and is found at high levels in patients with the diseases that Flixabi is used to treat. By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of these diseases.

What benefits of Flixabi have been shown in studies?

Studies were carried out to show that Flixabi is comparable to Remicade, including a study to show that it produces similar levels of the active substance in the body to Remicade.Flixabi was also compared with Remicade in one main study involving 584 patients with moderate to severe rheumatoid arthritis who had received previous treatment with methotrexate. The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 30 weeks of treatment. Results of this study showed that Flixabi was as effective as Remicade in reducing symptoms of rheumatoid arthritis: 64% of those treated with Flixabi (148 of 231 patients) had at least a 20% reduction in ACR scores, compared with 66% of those given Remicade (163 out of 247).

What are the risks associated with Flixabi?

The most common side effects with Flixabi (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper-respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain. Some side effects, including infections, may be more common in children than in adults. For the full list of all side effects reported with Flixabi, see the package leaflet.Flixabi must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Flixabi. Flixabi must also not be used in patients with tuberculosis, othersevere infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).

Why is Flixabi approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Flixabi has been shown to have a comparable quality, safety and effectiveness to Remicade. Therefore, the CHMP's view was that, as for Remicade, the benefit outweighs the identified risk. The Committee recommended that Flixabi be given marketing authorisation.

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

A risk management plan has been developed to ensure that Flixabi 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 Flixabi, including the appropriate precautions to be followed by healthcare professionals and patients.In addition, the company that markets Flixabi will provide an alert card for patients and educational material for prescribers, summarising the safety information about the medicine. In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.

---

Fluad Tetra

What is Fluad Tetra and what is it used for?

Fluad Tetra is a vaccine used to protect people aged from 65 years against influenza (flu).Flu is caused mainly by two types of influenza virus, known as influenza A and B. Each of these circulate as different strains, which change over time.Fluad Tetra will contain proteins from four different inactivated influenza A and B virus strains (two strains of type A influenza virus of the subtypes H1N1 and H3N2 and two type B strains). They are chosen according to the official recommendation for the annual flu season.The vaccine also contains an adjuvant, which helps to improve the vaccine's effectiveness. The viruses used for producing Fluad Tetra are grown in fertilized hens' eggs.

How is Fluad Tetra used?

Fluad Tetra is available as an injection in a pre-filled syringe. The recommended dose is a single injection (of 0.5 ml) into a muscle, preferably in the upper arm.The vaccine can only be obtained with a prescription and it should be used according to official recommendations.For more information about using Fluad Tetra, see the package leaflet or contact your doctor or pharmacist.

How does Fluad Tetra work?

Fluad Tetra is a vaccine. Vaccines work by preparing the immune system (the body's natural defences) to defend the body against a specific disease. Fluad Tetra contains small amounts of proteins of influenza viruses. When a person is given the vaccine, the immune system recognises the proteins in the vaccine as 'foreign' and makes antibodies against them. If the person then comes into contact with the virus, these antibodies, together with other components of the immune system, will be able to fight off the virus more effectively and so help to protect the person against the flu.Each year, the World Health Organization (WHO) recommends which flu strains should be included in flu vaccines for the upcoming flu season in the northern hemisphere. The composition of Fluad Tetra will be updated annually according to WHO and EU recommendations.

What benefits of Fluad Tetra have been shown in studies?

Studies in people aged 65 years or more investigated the effectiveness of Fluad Tetra at triggering the production of protective antibodies against flu.A study, involving over 7,000 people, found that antibody levels were generally higher when an adjuvant was included in the vaccine. The study compared an influenza vaccine that did not contain an adjuvant with one that contained the same adjuvant as Fluad Tetra. Both vaccines contained three of the four virus strains covered by Fluad Tetra.Another study, involving 1,776 people, found that after 22 days the level of antibodies resulting from Fluad Tetra vaccination were similar to those resulting from two other vaccines, each containing both influenza A virus strains and either one of the influenza B virus strains. All vaccines contained the same adjuvant.The company also presented information on the use of Fluad Tetra in children aged between 6 months and 6 years, but it withdrew its application for this use. Results from these studies did not clearly show that Fluad Tetra was sufficiently effective for protecting children against influenza.

What are the risks associated with Fluad Tetra?

The most common side effects with Fluad Tetra (which may affect more than 1 in 10 people), which generally last up to 3 days, are pain at the injection site, tiredness and headache.Fluad Tetra must not be used in people allergic to the active substances or any of the other ingredients or to the following substances which may be present in the vaccine in trace amounts: ovalbumin (egg protein), the antibiotics kanamycin and neomycin, formaldehyde, cetyltrimethylammonium bromide or hydrocortisone.For the full list of side effects and restrictions of Fluad Tetra, see the package leaflet.

Why is Fluad Tetra authorised in the EU?

In patients aged 65 years and over, Fluad Tetra stimulates a higher level of antibody production than influenza vaccines that do not contain an adjuvant. Because Fluad Tetra includes two influenza B virus strains, it can give broader protection than previous vaccines that contained only one strain. Side effects of Fluad Tetra are mostly mild to moderate and last only a short time.The European Medicines Agency therefore decided that Fluad Tetra'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 Fluad Tetra?

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

---

Flucelvax Tetra

What is Flucelvax Tetra and what is it used for?

Flucelvax Tetra is a vaccine used to protect adults and children from 2 years of age 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.Flucelvax Tetra contains proteins from four different inactivated influenza A and B virus strains (type A-H1N1, type A-H3N2 and two type B strains), chosen based on the official recommendation for the annual flu season.

How is Flucelvax Tetra used?

Flucelvax Tetra is available as an injection in a pre-filled syringe. The recommended dose is one single injection into a muscle (0.5 ml). A second dose should be given at least 4 weeks later to children less than 9 years of age who have not been previously vaccinated against flu.The vaccine can only be obtained with a prescription and should be used according to official recommendations.For more information about using Flucelvax Tetra, see the package leaflet or contact your doctor or pharmacist.

How does Flucelvax Tetra work?

Flucelvax Tetra is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Flucelvax Tetra contains proteins from the surface of four different strains of flu virus.When a person is given the vaccine, the immune system will treat the virus proteins as 'foreign' and makes defences against them. If, later on, the vaccinated person comes into contact with the virus, the immune system will recognise the virus proteins and be prepared to attack it. 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 Flucelvax Tetra will be updated annually according to WHO and EU recommendations. Historically, seasonal flu vaccines have contained three strains of flu: one influenza A-H1N1 virus, one influenza AH3N2 virus, and one influenza B virus. Flucelvax Tetra includes an additional B virus strain.

What benefits of Flucelvax Tetra have been shown in studies?

Flucelvax Tetra was effective in adults and children above 2 years of age.Two main studies in over 5,000 people from 4 years of age found that Flucelvax Tetra stimulated an immune response against influenza that was similar to that of two comparator vaccines, leading to similar levels of protective antibodies in people from 9 years of age. One of the comparator vaccines was Optaflu, a previously authorised vaccine which contains three of the four strains of influenza in Flucelvax Tetra and whose effectiveness in preventing flu was well established. The other vaccine is based on Optaflu but contains the other B strain of Flucelvax Tetra. Together the comparator vaccines contain the four strains of influenza in Flucelvax Tetra.In children aged from 2 to less than 18 years of age, Flucelvax Tetra was found to reduce the risk of getting flu. In a study in over 4,500 children, compared to a non-influenza vaccine, Flucelvax Tetra reduced the cases of flu: 7.8% of children vaccinated with Flucelvax Tetra got flu compared with16.2% of those given the non-influenza vaccine.

What are the risks associated with Flucelvax Tetra?

The most common side effects with Flucelvax Tetra in adults and children 2 years of age and above (which may affect more than 1 in 10 people, depending on age) are pain at the injection site, tenderness at the injection site, reddening of the skin, bruising and hardening at the injection site, headache, tiredness, irritability, change in eating habits or loss of appetite and muscle pain.Flucelvax Tetra must not be used in people who are hypersensitive (allergic) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine.For the full list of side effects and restrictions with Flucelvax Tetra, see the package leaflet.

Why is Flucelvax Tetra authorised in the EU?

Flucelvax Tetra is effective at stimulating immune responses against the strains included in the vaccine and preventing influenza illness in adults and children from 2 years of age. The inclusion of two influenza B strains in Flucelvax Tetra can provide a broader protection against influenza B. In terms of safety, side effects with Flucelvax Tetra are similar to those observed with vaccines containing three influenza strains and are mostly mild to moderate in severity.The European Medicines Agency therefore decided that Flucelvax Tetra's benefits are greater than its risks and it can be authorised for use in the EU.Flucelvax Tetra (influenza vaccine [surface antigen inactivated prepared in cell

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

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

---

Fluenz Tetra

What is Fluenz Tetra and what is it used for?

Fluenz Tetra is a vaccine used to protect children from 2 to less than 18 years of age against influenza (flu). Influenza is mainly caused by two kinds of influenza virus, known as influenza A and B. Each of these circulates as different strains or subtypes, which change over time. Fluenz Tetra will contain live attenuated (weakened) influenza A and B virus strains (type A-H1N1, type A-H3N2, and two type B strains) based on the official recommendation for the annual flu season.

How is Fluenz Tetra used?

Fluenz Tetra is available as a nasal spray. The recommended dose is one nasal spray (0.1 ml) per nostril. Children who have not been previously vaccinated against seasonal influenza should receive a second dose 4 weeks after the first.The vaccine can only be obtained with a prescription. Its use should be based on official recommendations.

How does Fluenz Tetra work?

Fluenz Tetra is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. Fluenz Tetra contains strains of flu virus that have first been weakened so that they do not cause disease.When a person is given the vaccine, the immune system recognises the virus as 'foreign' and makes defences against it. The immune system will then be able to respond more quickly when it is exposed to the virus again. 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 two A and two B strains in Fluenz Tetra will be updated with weakened virus strains for each season, according to WHO and European Union recommendations. Historically, seasonal flu vaccines have contained three strains of influenza: one influenza A-H1N1 virus, one influenza A-H3N2 virus, and one influenza B virus. The inclusion of both influenza B viruses in Fluenz Tetra can provide a broader protection against influenza B.The viruses used in Fluenz Tetra are grown in hens' eggs.

What benefits of Fluenz Tetra have been shown in studies?

The company provided three studies that compared Fluenz Tetra with Fluenz, an authorised influenza vaccine that contains three of the four strains of influenza in Fluenz Tetra and whose effectiveness is already established.Of these studies the main study involved over 2,000 children aged 2 to 17 years who were vaccinated with either Fluenz Tetra or one of two Fluenz vaccines containing either one of the two influenza B strains which are also contained in Fluenz Tetra. The study assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies. The study showed that patients vaccinated with Fluenz Tetra had immune responses against each of the four vaccine virus strains that were comparable to the immune responses stimulated by the Fluenz vaccines.

What are the risks associated with Fluenz Tetra?

The most common side effects with Fluenz Tetra (seen in more than 1 patient in 10) are reduced appetite, headache, blocked or runny nose and malaise (feeling unwell). For the full list of all side effects reported with Fluenz Tetra, see the package leaflet.Fluenz Tetra must not be used in children who are hypersensitive (allergic) to the active substances or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins. It must also not be given to children with a weakened immune system due to conditions such as blood disorders, symptomatic HIV infection, cancer or certain medical treatments, nor to children who are receiving treatment with salicylates (painkillers such as aspirin).

Why is Fluenz Tetra approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Fluenz Tetra's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the immune response stimulated by Fluenz Tetra was similar to the immune response stimulated by Fluenz. In addition, the CHMP considered the fact that the vaccine is given by nasalspray and not by injection and the fact that both influenza B viruses are included in the vaccine to be important advantages for children. The safety profile of Fluenz Tetra is similar to Fluenz and was considered acceptable.

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

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

---

Foclivia

What is Foclivia and what is it used for?

Foclivia is a vaccine used in adults to protect against flu when a 'pandemic' has been officially declared by the World Health Organization (WHO) or the European Union (EU). A flu pandemic occurs when a new type (strain) of flu virus can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Foclivia would be given according to official recommendations.Foclivia contains some parts of inactivated (killed) influenza (flu) virus. It contains a flu strain called A/Vietnam/1194/2004 (H5N1).

How is Foclivia used?

Foclivia is given by injection into the upper arm muscle or the thigh in two doses, at least 3 weeks apart.The vaccine can only be obtained with a prescription and should be used according to official recommendations.

How does Foclivia work?

Foclivia is a 'pandemic preparedness' vaccine. This is a special type of vaccine that can be developed to help with the management of a future pandemic.Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot prepare the correct vaccine in advance. Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune. They test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing a pandemic is included in the vaccine.Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a disease. Foclivia contains some parts the H5N1 virus.The virus has been first inactivated so that it does not cause disease. During a pandemic, the virus strain in Foclivia will have to be replaced by the strain causing the pandemic before the vaccine can be used.When a person is given the vaccine, the immune system recognises the virus as 'foreign' and makes antibodies against it. When the person comes into contact with this or a similar virus, these antibodies, together with other components of the immune system, will be able to kill the viruses and help protect against the disease.The immune system will then be able to produce antibodies more quickly when it comes into contact with the virus again. This helps to protect against the disease caused by the virus. The vaccine also contains an 'adjuvant' to increase the vaccine's effectiveness.

What benefits of Foclivia have been shown in studies?

The main study of Foclivia included 486 healthy people (a third of whom were over the age of 60) and compared the ability of two doses of Foclivia to trigger the production of antibodies (immunogenicity). The participants received two injections of Foclivia, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart. The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 22), and 21 days later (day 43).According to EMA's criteria, a pandemic preparedness vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.The study showed that Foclivia produced an antibody response that satisfies these criteria. Twenty-one days after the second injection, 86% of the people receiving the vaccine with 7.5 micrograms haemagglutinin had levels of antibodies that would protect them against H5N1. The figure was 85% in people who received the 15-microgram dose.

What are the risks associated with Foclivia?

The most common side effects with Foclivia (which may affect up to 1 people in 10) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, feeling unwell, tiredness and shivering. The majority of these side effects disappear within 1 to 2 days. For the full list of all side effects of Foclivia, see the package leaflet.Foclivia should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as egg, chicken protein, kanamycin or neomycin (antibiotics), formaldehyde and cetyltrimethylammonium bromide (CTAB). However, if a pandemic has started, it may be appropriate to give the vaccine to these people, as long as facilities for resuscitation are available.

Why is Foclivia authorised in the EU?

The European Medicines Agency decided that Foclivia's benefits are greater than its risk and it can be authorised for use in the EU.Foclivia has been authorised under 'exceptional circumstances'. This means that, because the vaccine is a pandemic preparedness vaccine and does not yet contain the strain of flu virus that is causing aFoclivia (pandemic influenza vaccine [H5N1] [surface antigen, inactivated,pandemic, it has not been possible to obtain full information about the final pandemic vaccine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Foclivia?

Since Foclivia has been authorised under exceptional circumstances, the company that markets Foclivia will collect information on the safety and effectiveness of the final pandemic vaccine when it includes the flu strain responsible for a pandemic in the vaccine.

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

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

---

Forsteo

What is Forsteo?

Forsteo is a medicine that contains the active substance teriparatide. It is available as a solution for injection in prefilled pens (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).

What is Forsteo used for?

Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:• women who have been through the menopause. In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;• men who are at an increased risk of fractures;• men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).The medicine can only be obtained with a prescription.

How is Forsteo used?

The recommended dose is 20 micrograms of Forsteo given once a day as an injection under the skin of the thigh or abdomen (tummy). Patients may inject themselves once they have been trained. A user manual is available for the pen.Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Forsteo can be used for up to two years. Only one two-year course of Forsteo should be given to a patient in their lifetime.

How does Forsteo work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall. Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.The active substance in Forsteo, 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.

How has Forsteo been studied?

Forsteo has been studied in three main studies. The first study involved 1,637 women with osteoporosis who had been through the menopause (average age: 69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months. The main measure of effectiveness was the number of new vertebral fractures at the end of the study, although the study also looked at non-vertebral fractures. The patients were treated for up to 23 months.The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years. The study included 429 women and men who had osteoporosis and had been taking glucocorticoids for at least three months.An additional study looked at the effects of Forsteo on bone density over two years in 234 women who had been through the menopause.

What benefit has Forsteo shown during the studies?

Forsteo was more effective than placebo in reducing vertebral fractures: 5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo. Forsteo reduced the risk of developing a new vertebral fracture over 19 months by 65% compared with placebo. It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.In the study in men, Forsteo increased bone density in the spine by about 6% after an average of almost 12 months.In the study of patients taking glucocorticoids, Forsteo was more effective than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.The studies also showed that the benefits of Forsteo treatment continued to increase for up to two years, with further increases in bone density.

What is the risk associated with Forsteo?

The most common side effect with Forsteo (seen in more than 1 patient in 10) is pain in the arms or legs. For the full list of all side effects reported with Forsteo, see the package leaflet.Forsteo 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) or severe kidney disease. Forsteo must not be used in children or in young adults whose bones are not yet fully mature, or during pregnancy or breastfeeding. For the full list of restrictions, see the package leaflet.

Why has Forsteo been approved?

The CHMP concluded that Forsteo'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 Forsteo?

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

---

Fortacin

What is Fortacin and what is it used for?

Fortacin is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).Fortacin contains the active substances lidocaine and prilocaine.

How is Fortacin used?

Fortacin can be obtained without a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray. The recommended dose is 3 sprays onto the head (glans) of the penis before intercourse. Doses should not be repeated more frequently than every 4 hours, and no more than 3 doses should be used in 24 hours. For more information about using Fortacin, see the package leaflet or contact your doctor or pharmacist.

How does Fortacin work?

The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by blocking the transmission of signals in the nerves. This reduces sensitivity to stimulation, helping to increase the time taken to ejaculate.

What benefits of Fortacin have been shown in studies?

The effectiveness of Fortacin has been shown in two main studies involving 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks. The main measures of effectiveness were the time taken to ejaculate after penetration and control over ejaculation, sexual satisfaction and distress reported by the patients. In the first study, the average time to ejaculation in patients treated with Fortacin was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study, average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minutes in the placebo group. In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo.Previously known as Lidocaine/Prilocaine Plethora.Some patients from the main studies were monitored for up to 9 and Fortacin continued to show similar benefit.

What are the risks associated with Fortacin?

The most common side effects with Fortacin (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men. For the full list of side effects with Fortacin, see the package leaflet.Fortacin must not be used in patients who are hypersensitive (allergic) to other local anaesthetics which are chemically similar with the active ingredients (amide-type local anaesthetics). Fortacin must also not be used in patients whose partners are hypersensitive to these substances. For the full list of restrictions, see the package leaflet.

Why is Fortacin approved?

The European Medicines Agency considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole. There were positive psychological benefits to patients and their partners, and side effects were generally manageable and confined to the area coming into contact with the medicine. The Agency therefore decided that Fortacin'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 Fortacin?

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

---

Forxiga

What is Forxiga and what is it used for?

Forxiga is a medicine used to treat type 2 diabetes, chronic (long-term) heart failure and chronic kidney disease.In type 2 diabetes, Forxiga is used in adults and children from 10 years of age whose condition is not controlled well enough. It is used with appropriate diet and exercise in patients who cannot take metformin (another diabetes medicine). It can also be used as 'add-on' treatment to other diabetes medicines.In chronic heart failure (inability of the heart to pump enough blood around the body), Forxiga is used in adults who have symptoms of the disease. Forxiga is also used in adults with chronic kidney disease.Forxiga contains the active substance dapagliflozin.

How is Forxiga used?

Forxiga is available as tablets and can only be obtained with a prescription.For type 2 diabetes, chronic heart failure and chronic kidney disease, the recommended dose of Forxiga is 10 mg once a day.For type 2 diabetes, if Forxiga is used with insulin or medicines that help the body produce insulin, the doses of these medicines may need to be reduced to prevent hypoglycaemia (low blood sugar levels).For more information about using Forxiga, see the package leaflet or contact your doctor or pharmacist.

How does Forxiga work?

The active substance in Forxiga, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). As blood is filtered by the kidneys, SGLT2 stops the kidneys passing glucose from the blood into the urine. Patients with diabetes have high levels of glucose in theblood. By blocking the action of SGLT2, dapagliflozin causes the kidney to pass more glucose into the urine, thereby reducing the levels of glucose in the blood.Blocking the action of SGLT2 also supports heart function in patients with chronic heart failure and kidney function in patients with chronic kidney disease, regardless of having diabetes. Dapagliflozin's actions increase the elimination of salt and water in the urine. This decreases the overall blood volume, reducing the effort needed for the heart to pump blood, thereby improving its function in patients with heart failure.

What benefits of Forxiga have been shown in studies?

Type 2 diabetesForxiga was found effective in several studies in patients with type 2 diabetes. The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.In two studies involving 840 adults with type 2 diabetes, Forxiga, when used alone, decreased HbA1c levels by 0.66 percentage points more than placebo (a dummy treatment) after 24 weeks. In four other studies involving over 2,300 adults, adding Forxiga to other diabetes medicines decreased HbA1c levels by 0.54-0.68 percentage points more than adding placebo after 24 weeks.In a study involving 814 adults with type 2 diabetes, Forxiga used in combination with metformin was at least as effective as a sulphonylurea (another type of diabetes medicines) used with metformin.Both combinations reduced HbA1c levels by 0.52 percentage points after 52 weeks.A long-term study, involving over 17,000 adults with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease. The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.The effects of Forxiga in combination with metformin and/or insulin were also investigated in a study involving 72 children and young adults between 10 and 24 years of age with type 2 diabetes. Although HbA1c levels decreased in patients treated with Forxiga compared with those given placebo, the results of the study alone were not robust enough to demonstrate the effect of Forxiga in children. However, these results and additional data on the disease in children and data on how the medicine is absorbed, modified and removed from the body in children compared with adults support that Forxiga works in the same way in children and in adults.Heart failureForxiga was effective at reducing the risk of death, hospitalisation or urgent medical visit due to heart failure in two main studies involving about 4,700 and 6,200 adult patients with heart failure. In these studies, Forxiga was compared with placebo, both added to the patients' usual treatment for heart failure.The first study involved patients with heart failure with reduced ejection fraction (when the muscle of the heart is not pumping blood as well as normal). The rate of death and hospitalisation or urgent medical visit per 100 patient years was 11.6 in the Forxiga group compared with 15.6 in the placebo group; the risk was 26% lower with Forxiga than with placebo.The second study involved patients with heart failure without reduced ejection fraction. The rate of death, hospitalisation or urgent medical visit per 100 patient years was 7.8 in the Forxiga group compared with 9.6 in the placebo group; the risk was 18% lower with Forxiga than with placebo.Chronic kidney diseaseForxiga was effective in treating adult patients with chronic kidney disease based on a study involving over 4,300 patients. When Forxiga was added to the patients' usual treatment for chronic kidney disease, the proportion of patients that experienced a decline in kidney function, severe kidney disease or death was 9.2% in the Forxiga group compared with 14.5% in the placebo group; the risk was 39% lower with Forxiga than with placebo.

What are the risks associated with Forxiga?

The most common side effect with Forxiga in patients with type 2 diabetes (which may affect more than 1 in 10 people) is hypoglycaemia (low blood sugar levels) when used in combination with a sulphonylurea or insulin.For the full list of side effects and restrictions with Forxiga, see the package leaflet.

Why is Forxiga authorised in the EU?

The European Medicines Agency considered that Forxiga was effective for treating type 2 diabetes in adults and children from 10 years of age when given alone or in combination with other diabetes medicines which work in different ways. In addition, beneficial reductions in weight and blood pressure occurred in patients treated with Forxiga. In heart failure, Forxiga can reduce the risk of death or serious complications in patients with heart failure. In patients with chronic kidney disease Forxiga can reduce the risk of kidney function decline or death due to kidney or heart problems, when added to the patient's usual treatment.Forxiga's common side effects were related to raised levels of sugar in the urine, such as increased genital and, to a smaller degree, urinary infection, and are considered manageable.The Agency concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.

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

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

---

Fosavance

What is Fosavance?

Fosavance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3). It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol).

What is Fosavance used for?

Fosavance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels. Fosavance 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements. Fosavance reduces the risk of fractures (broken bones) in the spine and the hip.The medicine can only be obtained with a prescription.

How is Fosavance used?

The recommended dose of Fosavance is one tablet once a week. It is intended for long-term use.The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins). To avoid irritation of the oesophagus (the tube that leads from the mouth to the stomach), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet. The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.

How does Fosavance work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.Fosavance contains two active substances: alendronic acid and colecalciferol (vitamin D3). Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s. It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss. Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight. Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation. Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.

How has Fosavance been studied?

Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Fosavance's ability to increase vitamin D levels. Patients received either Fosavance 70 mg/2,800 IU or alendronic acid only once a week. The main measure of effectiveness was the reduction in the number of patients with low vitamin D levels after 15 weeks. This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Fosavance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Fosavance 70 mg/5,600 IU).

What benefit has Fosavance shown during the studies?

The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Fosavance was the same as the dose needed to prevent bone loss.The additional studies showed that including vitamin D3 in the same tablet with alendronic acid could increase vitamin D levels. After 15 weeks, fewer patients had low vitamin D levels when they took Fosavance 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%). In the extension study, similar numbers of patients taking Fosavance 70 mg/2,800 IU and Fosavance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Fosavance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.

What is the risk associated with Fosavance?

The most common side effects with Fosavance (seen between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas),ulcers in the oesophagus, dysphagia (difficulty swallowing), abdominal distension (swollen tummy), acid regurgitation and musculoskeletal pain (pain in the muscles, bones and joints). For the full list of all side effects reported with Fosavance, see the package leaflet.Fosavance must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes. for the full list of restrictions, see the package leaflet.

Why has Fosavance been approved?

The CHMP decided that Fosavance'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 Fosavance?

A risk management plan has been developed to ensure that Fosavance 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 Fosavance, including the appropriate precautions to be followed by healthcare professionals and patients.

---

Foscan

What is Foscan?

Foscan is a solution for injection containing the active substance temoporfin (1 mg/ml).

What is Foscan used for?

Foscan is used to relieve the symptoms of advanced head and neck squamous cell carcinoma (a type of cancer that starts in the cells lining the mouth, nose, throat or ear). It is used in patients in whom other treatments have stopped working, and who are not suitable for radiotherapy (treatment with radiation), surgery or systemic chemotherapy (medicines used to treat cancer; 'systemic' means that they are given as treatments throughout the body).The medicine can only be obtained with a prescription.

How is Foscan used?

Foscan must only be given in a specialist cancer centre where a team can assess the patient's treatment under the supervision of a doctor who has experience in photodynamic therapy (treatment that uses light).Treatment with Foscan is a two-step process: the medicine is given first, and then it is activated using a laser. The medicine is given by an indwelling intravenous cannula (a thin tube permanently inserted into a vein) as a single slow injection over at least six minutes. The dose is 0.15 mg per kilogram body weight. Four days later, the entire surface of the tumour and the surrounding 0.5 cm margin is illuminated with light from a laser at a specific wavelength, using a fibre-optic cable. Each area of thetumour should be illuminated only once during each treatment. During treatment, other areas of the body should be shielded from the light so that the activation of the medicine is limited to the tumour.If a second treatment is necessary, this should take place at least four weeks later.

How does Foscan work?

The active substance in Foscan, temoporfin, is a photosensitising agent (a substance that changes when exposed to light). When Foscan is injected, temoporfin is distributed within the body, including within the tumour. When it is illuminated with laser light of a specific wavelength, temoporfin is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen. This kills the cells by reacting with and destroying their components, such as their proteins and DNA. By restricting the illumination to the tumour, cell damage is limited to the tumour cells, leaving other areas of the body unaffected.

How has Foscan been studied?

Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer. The first three studies looked at whether the tumour was eradicated after up to three treatments with Foscan in a total of 189 patients. The fourth study looked at the reduction of symptoms in 220 patients with advanced head or neck cancer who could not receive surgery or radiotherapy. In all studies, the response was assessed between 12 and 16 weeks after the final treatment with Foscan, but Foscan was not compared with any other treatment.

What benefit has Foscan shown during the studies?

The results of the first three studies were insufficient to support the use of Foscan in the eradication of head and neck cancer tumours. However, in the study looking at improving symptoms of advanced head and neck cancer, 28 (22%) of the 128 patients assessed had a significant improvement in their most troubling symptom. Around a quarter of the patients in this study also had a reduction in tumour size.

What is the risk associated with Foscan?

The most common side effects with Foscan (seen in more than 1 patient in 10) are pain in the illuminated area (such as pain in the face), headache, pain at the injection site, haemorrhage(bleeding), scarring, necrotising stomatitis (death of cells or tissue in the mouth), dysphagia (difficulty swallowing), oedema (swelling) in the illuminated area (such as swelling of the face and tongue) and constipation. For the full list of all side effects reported with Foscan, see the package leaflet.Foscan must not be used in people who are hypersensitive (allergic) to temoporfin or any of the other ingredients. Foscan must not be used in patients with porphyria (an inability to break down porphyrins), other diseases made worse by light, allergy to porphyrins, or tumours that are spreading into a main blood vessel in or next to the area where the laser is to be shone. Foscan must also not be used in patients who have an operation planned in the next 30 days, who have an eye disease that is likely to need examination using a 'slit lamp' (an instrument used by eye specialists to look into the eye) in the next 30 days, or who are already being treated with a photosensitising agent.Patients receiving Foscan should take care to avoid exposure to sun light or bright light for two weeks after injection to avoid skin burns. Further care must be taken for up to six months. See the package leaflet for full details.

Why has Foscan been approved?

The CHMP concluded that Foscan's effects on relieving the symptoms associated with advanced head and neck cancer were of interest. Therefore, the Committee decided that Foscan's benefits are greater than its risks and recommended that it be given marketing authorisation.

---

Fotivda

What is Fotivda and what is it used for?

Fotivda is a medicine for treating adults with advanced renal cell carcinoma (a kidney cancer).Fotivda may be used in previously untreated patients or in those whose disease has got worse despite treatment with another medicine working in a different way.It contains the active substance tivozanib.

How is Fotivda used?

Fotivda is available as capsules (890 and 1,340 micrograms). The usual dose is one 1,340-microgram capsule once a day for three weeks, followed by a week when the patient does not take any capsules. The patients should continue repeating this 4-week course for as long as the disease does not get worse or until side effects become unacceptable. If the patient has troublesome side effects, the doctor may decide to switch to the lower-strength 890-microgram capsules or interrupt treatment.Fotivda can only be obtained with a prescription, and treatment should be supervised by a doctor with experience of treating cancers. For further information, see the package leaflet.

How does Fotivda work?

The active substance in Fotivda, tivozanib, works by blocking the activity of proteins known as VEGF, which stimulate the formation of new blood vessels. By blocking this protein, tivozanib stops the formation of new blood vessels that the tumour needs, thereby cutting off its blood supply and reducing the growth of the cancer.

What benefits of Fotivda have been shown in studies?

A main study of 517 patients with advanced renal cell carcinoma that had either come back or spread to other parts of the body has shown that Fotivda can help stop the disease from getting worse. In this study, patients taking Fotivda lived for longer without their disease worsening (12 months) than those given another approved medicine sorafenib (9 months).

What are the risks associated with Fotivda?

The most important serious side effect with Fotivda is high blood pressure. The most common side effects are high blood pressure (which occurs in almost half of patients) and voice changes, tiredness and diarrhoea (which occur in about a quarter of patients). For the full list of all side effects, see the package leaflet.Patients must not take St John's wort (a herbal remedy for depression) during treatment with Fotivda.For the full list of restrictions, see the package leaflet.

Why is Fotivda approved?

A main study showed that Fotivda increased the time it took for the disease to get worse by almost 3 months when compared with another approved medicine sorafenib. The most common side effects with Fotivda are considered manageable, although they may affect the patient's quality of life. On the whole, its side effects are in line with what is expected of a medicine of its class (VEGF inhibitors).The European Medicines Agency therefore concluded that the benefits of Fotivda outweighed its risk and recommended that it be granted authorisation in the EU.

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

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

---

Fulphila

What is Fulphila and what is it used for?

Fulphila is a medicine used in cancer patients 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 (when neutropenia is accompanied by fever).Fulphila is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).Fulphila is a 'biosimilar medicine'. This means that Fulphila is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Fulphila is Neulasta. For more information on biosimilar medicines, see here.

How is Fulphila used?

Fulphila 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. Fulphila 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 Fulphila, see the package leaflet or contact your doctor or pharmacist.

How does Fulphila work?

The active substance in Fulphila, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF). Filgrastim works by encouraging thebone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.Filgrastim has been available in other medicines in the European Union (EU) for a number of years. In Fulphila, 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 Fulphila have been shown in studies?

Laboratory studies comparing Fulphila with Neulasta have shown that the active substance in Fulphila is highly similar to that in Neulasta in terms of structure, purity and biological activity. Studies have also shown that giving Fulphila produces similar levels of the active substance in the body to giving Neulasta.In addition, a study involving 194 patients who had chemotherapy before or after surgery for breast cancer showed that Fulphila was as effective as Neulasta in reducing the duration of neutropenia. Neutropenia lasted 1 day on average with both medicines.Because Fulphila is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Fulphila.

What are the risks associated with Fulphila?

The safety of Fulphila 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 Fulphila (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 Fulphila, see the package leaflet.

Why is Fulphila authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Fulphila has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Fulphila is equivalent to that of Neulasta in reducing the duration of neutropenia.All these data were considered sufficient to conclude that Fulphila 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 benefit of Fulphila 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 Fulphila?

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

---

Fulvestrant Mylan

What is Fulvestrant Mylan and what is it used for?

Fulvestrant Mylan is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women with a type of breast cancer known as 'oestrogen-receptor positive cancer' who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen.Fulvestrant Mylan contains the active substance fulvestrant.Fulvestrant Mylan is a 'generic medicine'. This means that Fulvestrant Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Faslodex. For more information on generic medicines, see the question-and-answer document here.

How is Fulvestrant Mylan used?

Fulvestrant Mylan can only be obtained with a prescription and is available as a solution for injection in prefilled syringes (250 mg). The recommended dose is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose. The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.

How does Fulvestrant Mylan work?

Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells. The active substance in Fulvestrant Mylan, fulvestrant, is an antioestrogen. It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall. As a result, the cancer cells are not stimulated to grow by oestrogen and this slows down the growth of the tumour.

How has Fulvestrant Mylan been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Faslodex, and do not need to be repeated for Fulvestrant Mylan.As for every medicine, the company provided studies on the quality of Fulvestrant Mylan. There was no need for 'bioequivalence' studies to investigate whether Fulvestrant Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Fulvestrant Mylan is the same as the reference medicine and when given by injection into the muscle, the active substance in both products is expected to be absorbed in the same way.

What are the benefits and risks of Fulvestrant Mylan?

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

Why is Fulvestrant Mylan approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Fulvestrant Mylan has been shown to be comparable to Faslodex. Therefore, the Agency's view was that, as for Faslodex, the benefit outweighs the identified risk. The Agency recommended that Fulvestrant Mylan be approved for use in the EU.

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

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

---

Fuzeon

What is Fuzeon?

Fuzeon is a powder that is made up into a solution for injection. It contains the active substance enfuvirtide (90 mg/ml).

What is Fuzeon used for?

Fuzeon is an antiviral medicine. It is used in combination with other antiviral medicines for the treatment of patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is for use in patients who have stopped responding to, or cannot take, other antiviral medicines. These must include at least one medicine from each of the following classes of medicine used to treat HIV infection: protease inhibitors; non-nucleoside reverse transcriptase inhibitors; and nucleoside reverse transcriptase inhibitors.Doctors should only prescribe Fuzeon once they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine. The medicine can only be obtained with a prescription.

How is Fuzeon used?

Fuzeon should be prescribed by a doctor who has experience in the treatment of HIV infection. In adults, it is given as one 90-mg injection twice a day, injected under the skin of the upper arm, upper thigh or abdomen (tummy). The dose for children aged six to 16 years depends on body weight. Fuzeon is not recommended for use in children under six years of age.Fuzeon can be injected by the patient or by a carer, provided that the person giving the injection follows the detailed instructions given in the Package Leaflet. The site of injection must be changed for each injection.

How does Fuzeon work?

The active substance in Fuzeon, enfuvirtide, is a fusion inhibitor. Fuzeon binds to a protein on the surface of HIV. This prevents the virus from attaching to the surface of human cells and infecting them. As HIV can only reproduce itself within cells, Fuzeon, taken in combination with other antiviral medicines, reduces the level of HIV in the blood and keeps it at a low level. Fuzeon does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Fuzeon been studied?

The two main studies of Fuzeon included 1,013 patients aged 16 years or over who were infected with HIV and had taken, or were not responding to, other antiviral medicines. On average, the patients had been given an average of 12 antiviral medicines over a seven-year period. Both studies compared the effects of Fuzeon, in combination with 'optimised background therapy' (a combination of other antiviral medicines chosen for each patient as they had the best chances of reducing the levels of HIV in the blood), compared with optimised background therapy without Fuzeon. The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) after 48 weeks of treatment. Fuzeon has also been studied in 39 children aged between three and 16 years. The studies were still ongoing at the time of the medicine's assessment.

What benefit has Fuzeon shown during the studies?

Taking Fuzeon with optimised background therapy was more effective at reducing viral loads than optimised background therapy alone. In the first study, viral loads fell by an average of 98% in the patients taking Fuzeon, compared with 83% in the patients not taking Fuzeon. The values in the second study were 96 and 78%, respectively. The approved dose of Fuzeon in children brings about similar levels of the active substance in the blood to the approved dose in adults.

What is the risk associated with Fuzeon?

The most common side effects with Fuzeon (seen in more than 1 patient in 10) are injection site reactions (pain and inflammation at the site of injection), peripheral neuropathy (damage to the nerves in the extremities causing tingling or numbness in the hands and feet) and weight loss. In clinical studies, injection site reactions have been reported in 98% of patients, mostly occurring within the first week of treatment. It caused mild to moderate pain or discomfort, which did not increase during treatment. For the full list of all side effects reported with Fuzeon, see the Package Leaflet.Fuzeon should not be used in people who may be hypersensitive (allergic) to enfuvirtide or any of the other ingredients.As with all other anti-HIV medicines, patients taking Fuzeon may be at risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system). Patients who have problems with their liver may be at an elevated risk of liver damage when taking treatment for HIV infection.

Why has Fuzeon been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Fuzeon's benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. The Committee recommended that Fuzeon be given marketing authorisation.Fuzeon was originally authorised under 'Exceptional Circumstances', because for scientific reasons it had not been possible to obtain complete information on the medicine. As the company had supplied the additional information requested, the 'Exceptional Circumstances' ended on 8 July 2008. 2008.

---

Fycompa

What is Fycompa and what is it used for?

Fycompa is an epilepsy medicine for treating:• partial seizures (fits starting in one specific part of the brain), including those followed by generalised seizures affecting all of the brain, in patients from 4 years of age;• primary generalised tonic-clonic seizures (major fits fit affecting most or all of the brain) in patients from 7 years of age when the cause of epilepsy is unknown.Fycompa must only be used as an 'add-on' therapy to other anti-epileptic medicines. It contains the active substance perampanel.

How is Fycompa used?

Fycompa is taken by mouth once a day at bedtime. Fycompa tablets can be taken with or without food and should not be chewed, crushed or split. Fycompa oral suspension can be taken with or without food and should always be taken in the same way (i.e. always with food or always without food).For patients above 12 years of age, the recommended dose at the start of treatment is 2 mg per day, and if it is well tolerated the doctor may progressively increase it by increments of 2 mg/day to a maximum dose of 12 mg per day. For younger patients the dose depends on their weight.Fycompa can only be obtained with a prescription. For more information about using Fycompa, see the package leaflet or contact your doctor or pharmacist.

How does Fycompa work?

The active substance in Fycompa, perampanel, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. Although the precise mechanism by which Fycompa works is not fully understood, it is thought to block the action of the neurotransmitter glutamate.Neurotransmitters are naturally-occurring chemicals in the nervous system that allow nerve cells to communicate with each other. Glutamate is the main stimulatory neurotransmitter in nerve cells that can trigger and maintain seizures. Therefore, by blocking glutamate's actions, Fycompa is thought to stop epileptic seizures from occurring.

What benefits of Fycompa have been shown in studies?

Three main studies involving a total of 1,491 patients aged 12 years and older showed that Fycompa was more effective than placebo (a dummy treatment) in reducing the frequency of partial seizures. In the first study, the percentage of patients who experienced a decrease in seizure frequency of at least 50% was 37.6% for patients taking 8 mg Fycompa and 36.1% for patients taking 12 mg Fycompa, compared with 26.4% of patients taking placebo. In the second study, 33.3% and 33.9% of patients taking 8 mg and 12 mg Fycompa respectively showed a decrease in seizure frequency of at least 50%, compared with 14.7% of patients taking placebo. The third study showed a significant decrease in seizure frequency only in patients taking 4 mg and 8 mg Fycompa but not in patients taking a dose of 2 mg.A fourth study in 164 patients with generalised epilepsy of unknown cause also showed that Fycompa was more effective than placebo: 47 of 81 patients (58%) given Fycompa had at least a 50% reduction in frequency of seizures, compared with 29 of 81 (36%) of those given the dummy treatment. Supportive evidence from patients treated for up to 2 years suggested that the benefit was maintained with longer treatment and that some patients could benefit from doses up to 12 mg.Additional data indicate that Fycompa is as effective in younger children as in those above 12 years of age.

What are the risks associated with Fycompa?

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

Why is Fycompa authorised in the EU?

Studies showed that Fycompa, taken together with other anti-epileptic medicines, showed a consistent reduction in the frequency of epileptic fits and its side effects are manageable. The European Medicines Agency decided that Fycompa'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 Fycompa?

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

---