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Lacosamide Accord

What is Lacosamide Accord and what is it used for?

Lacosamide Accord is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 16 years or older. It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).Lacosamide Accord is given on its own or combined with other medicines for epilepsy.Lacosamide Accord contains the active substance lacosamide. It is a 'generic medicine'. This means that Lacosamide Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the European Union (EU) called Vimpat. For more information on generic medicines, see the question-and-answer document here.

How is Lacosamide Accord used?

The medicine can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg). The usual starting dose is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines. If the doctor decides that a faster effect is needed, treatment with Lacosamide Accord may be started with a higher first dose (called a loading dose).If treatment with Lacosamide Accord has to be stopped, the dose should be gradually reduced. For further information, see the package leaflet.

How does Lacosamide Accord work?

The active substance in Lacosamide Accord, lacosamide, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells. It is also thought that lacosamide might help protect nerve cells from damage. Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.

How has Lacosamide Accord 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, Vimpat, and do not need to be repeated for Lacosamide Accord.As for every medicine, the company provided studies on the quality of Lacosamide Accord. There was no need for 'bioequivalence' studies to investigate whether Lacosamide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the active substance, lacosamide, has been shown to be highly soluble and completely absorbed, meaning that almost 100% of the substance reaches the blood when taken by mouth.

What are the benefits and risks of Lacosamide Accord?

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

Why is Lacosamide Accord approved?

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

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

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

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Lacosamide Adroiq

What is Lacosamide Adroiq and what is it used for?

Lacosamide Adroiq is a medicine used on its own or as an add-on to other epilepsy medicines in the treatment of partial-onset seizures (epileptic fits starting in one specific part of the brain) with or without secondary generalisation (where the abnormal electrical activity spreads through the brain) in patients with epilepsy aged 2 years and older.Lacosamide Adroiq can also be used as add-on to other epilepsy medicines in the treatment of primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 4 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).Lacosamide Adroiq is a 'generic medicine'. This means that Lacosamide Adroiq contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU. The reference medicine for Lacosamide Adroiq is Vimpat. For more information on generic medicines, see the question-and-answer document here.Lacosamide Adroiq contains the active substance lacosamide.

How is Lacosamide Adroiq used?

Lacosamide Adroiq is available as a solution for infusion (drip) into a vein and is given twice a day.The medicine can only be obtained with a prescription.For more information about using Lacosamide Adroiq, see the package leaflet or contact your doctor or pharmacist.

How does Lacosamide Adroiq work?

The active substance in Lacosamide Adroiq, lacosamide, is an epilepsy medicine. Epilepsy is caused by abnormal electrical activity in the brain. The exact way in which lacosamide works is unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells. This action may prevent abnormal electrical activity in the brain, reducing the chance of an epileptic fit.Send

How has Lacosamide Adroiq been studied?

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

What are the benefits and risks of Lacosamide Adroiq?

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

Why is Lacosamide Adroiq authorised in the EU?

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

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

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

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Lacosamide Ucb

What is Lacosamide UCB and what is it used for?

Lacosamide UCB is a medicine used on its own or as an add-on to other epilepsy medicines in the treatment of partial-onset seizures (epileptic fits starting in one specific part of the brain) with or without secondary generalisation (where the abnormal electrical activity spreads through the brain) in patients aged 24 years or older.Lacosamide UCB can also be used as add-on to other epilepsy medicines in the treatment of primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 4 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).Lacosamide UCB contains the active substance lacosamide and is the same as Vimpat, which is already authorised in the EU. The company that makes Vimpat has agreed that its scientific data can be used for Lacosamide UCB ('informed consent').

How is Lacosamide UCB used?

The medicine can only be obtained with a prescription and is available as tablets, as a syrup and as a solution for infusion (drip) into a vein. Lacosamide UCB should be taken twice a day; the dosage depends on the patient's weight and age, as well as whether Lacosamide UCB is used alone or with other epilepsy medicines.Lacosamide UCB infusion can be used to begin treatment. It can also be used in patients who are temporarily unable to take the medicine by mouth.For more information about using Lacosamide UCB, see the package leaflet or contact your doctor or pharmacist.

How does Lacosamide UCB work?

The active substance in Lacosamide UCB, lacosamide, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allowelectrical impulses to be transmitted between nerve cells. This action may prevent abnormal electrical activity in the brain, reducing the chance of an epileptic fit.

What benefits of Lacosamide UCB have been shown in studies?

Partial-onset seizuresLacosamide UCB was effective at reducing partial-onset seizures in three main studies involving a total of 1,308 patients aged 16 years and above also taking other epilepsy medicines. Patients were given Lacosamide UCB by mouth at a dose of 200 mg, 400 mg or 600 mg a day, or placebo (a dummy treatment) in addition to their existing epilepsy medicines. Taking the results of the three main studies together, 34% of the patients taking Lacosamide UCB 200 mg a day and 40% of those taking Lacosamide UCB 400 mg a day with their existing treatment had a reduction in their seizures by at least half after 12 weeks of treatment. This compared with 23% of the patients receiving placebo. The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.A fourth study involving 888 recently diagnosed patients found that Lacosamide UCB, used on its own at a dose of 200 mg to 600 mg a day, was at least as effective as carbamazepine, another epilepsy medicine. The main measure of effectiveness was the proportion of patients who did not have a partial-onset seizure for at least 6 months after reaching a stable dose. This was found to be 90% in those taking Lacosamide UCB and 91% in those taking carbamazepine. Around 78% of Lacosamide UCB-treated and 83% of carbamazepine-treated patients did not have a seizure for 12 months.Two additional studies looked at the appropriate duration of the infusion for Lacosamide UCB solution and compared its safety with that of placebo infusions in a total of 199 patients. An additional study in 118 patients was carried out to test that starting treatment with doses of 200 mg Lacosamide UCB by infusion, followed by regular doses taken by mouth, can be applied safely and that adequate levels in the body are achieved. The company also provided data to support dosing of Lacosamide UCB in children from 24 years of age and supportive results from studies of the safety of Lacosamide UCB in this population.Tonic-clonic seizuresA further study involving 242 patients from 4 years with idiopathic generalised epilepsy compared Lacosamide UCB with placebo, both used with other epilepsy medicines. The study showed that Vimpat lowered the risk of having a tonic-clonic seizure: after 24 weeks of treatment, around 31% of patients taking Vimpat were free from seizures compared with around 17% of patients receiving placebo.

What are the risks associated with Lacosamide UCB?

The most common side effects with Lacosamide UCB (which may affect more than 1 in 10 people) are dizziness, headache, diplopia (double vision) and nausea (feeling sick). The risk of side effects affecting the nervous system such as dizziness may be higher after a high first dose and dizziness was the most common reason for stopping treatment.Lacosamide UCB must not be used in people who have second- or third-degree AV block (a type of heart rhythm disorder). For the full list of side effects and restrictions of Lacosamide UCB, see the package leaflet.

Why is Lacosamide UCB authorised in the EU?

The European Medicines Agency decided that Lacosamide UCB, used alone or added to other epilepsy medicines, had been shown to be effective in the treatment of partial-onset and tonic clonic seizures.Taking its side effects into account, the Agency decided that Lacosamide UCB'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 Lacosamide UCB?

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

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Lamivudine Teva

What is Lamivudine Teva?

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

What is Lamivudine Teva used for?

Lamivudine Teva is used to treat adult patients who have chronic (long term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus). It is used in patients with compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme 'alanine aminotransferase' [ALT] and signs of damage when liver tissue is examined under a microscope). Because the hepatitis B virus can become resistant to Lamivudine Teva, the doctor should only consider prescribing Lamivudine Teva if other treatments that are less likely to lead to resistance cannot be used.The medicine can only be obtained with a prescription.

How is Lamivudine Teva used?

Treatment with Lamivudine Teva should be initiated by a doctor who has experience in the management of chronic hepatitis B. The recommended dose of Lamivudine Teva is 100 mg once a day. The dose needs to be lowered for patients who have problems with their kidneys. Lamivudine Teva is not suitable for patients who require doses below 100 mg. The duration of treatment depends on the patient's condition and response to treatment.If the hepatitis B virus can still be found in the blood after six months of treatment, the doctor should consider changing treatment to reduce the risk of resistance. Patients infected with a virus that has the 'YMDD mutation' (a change in the virus's DNA that is often found after treatment with lamivudine) should take Lamivudine Teva in combination with another medicine against hepatitis B. For more information, please see the Summary of Product Characteristics (also part of the EPAR).

How does Lamivudine Teva work?

The active substance in Lamivudine Teva, lamivudine, is an antiviral agent belonging to the class of the nucleoside analogues. Lamivudine interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA. Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.

How has Lamivudine Teva been studied?

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

What are the benefits and risks of Lamivudine Teva?

Because Lamivudine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

Why has Lamivudine Teva been approved?

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

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Lamivudine Teva Pharma B.V.

What is Lamivudine Teva Pharma B.V.?

Lamivudine Teva Pharma B.V. is an antiviral medicine containing the active substance lamivudine. It is available as tablets (150 and 300 mg).Lamivudine Teva Pharma B.V. is a 'generic medicine'. This means that Lamivudine Teva Pharma B.V. is similar to a 'reference medicine' already authorised in the European Union (EU) called Epivir. For more information on generic medicines, see the question-and-answer document here.

What is Lamivudine Teva Pharma B.V. used for?

Lamivudine Teva Pharma B.V. is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).The medicine can only be obtained with a prescription.

How is Lamivudine Teva Pharma B.V. used?

Treatment with Lamivudine Teva Pharma B.V. should be initiated by a doctor who has experience in the management of HIV infection.The recommended dose of Lamivudine Teva Pharma B.V. for adults and children weighing at least 25 kg is 300 mg a day. This can be taken either as a single daily dose or divided into 150 mg twice a day. In children weighing less than 25 kg the recommended dose depends on their weight.Lamivudine Teva Pharma B.V. tablets should ideally be swallowed without crushing. Patients who cannot swallow tablets should use an oral solution of lamivudine, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it. The dose of Lamivudine Teva Pharma B.V. needs to be adjusted in patients who have severe problems with their kidneys. An oral solution of lamivudine can be used to achieve the appropriate dose. For more information, see the package leaflet.

How does Lamivudine Teva Pharma B.V. work?

The active substance in Lamivudine Teva Pharma B.V., lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI). It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell. Lamivudine Teva Pharma B.V., taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Lamivudine Teva Pharma B.V. does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

How has Lamivudine Teva Pharma B.V. been studied?

Because Lamivudine Teva Pharma B.V. is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Epivir. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Lamivudine Teva Pharma B.V.?

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

Why has Lamivudine Teva Pharma B.V. been approved?

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

What measures are being taken to ensure the safe and effective use of Lamivudine Teva Pharma B.V.?

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

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Lamzede

What is Lamzede and what is it used for?

Lamzede is a medicine used for patients with mild to moderate alpha-mannosidosis. It is used for treating effects of the disease that do not involve the brain (non-neurological effects).Alpha-mannosidosis is an inherited disease with features that include learning disability, difficulty controlling movement, deafness, speaking difficulty, frequent infections, enlarged liver and spleen, bone abnormalities, and muscle pain and weakness.Lamzede contains the active substance velmanase alfa.Alpha-mannosidosis is rare, and Lamzede was designated an 'orphan medicine' (a medicine used in rare diseases) on 26 January 2005. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.

How is Lamzede used?

Lamzede can only be obtained with a prescription. Treatment should be supervised by a doctor experienced in treating alpha-mannosidosis or in giving enzyme replacement treatments for similar conditions.Lamzede is given by infusion (drip) into a vein at a dose of 1 mg per kg of body weight once a week. The infusion is given over at least 50 minutes, using a pump to control the speed of infusion.For more information about using Lamzede, see the package leaflet or contact your doctor or pharmacist.

How does Lamzede work?

Patients with alpha-mannosidosis lack an enzyme called alpha-mannosidase which is important for breaking down certain glycosides (substances that contain proteins and sugars). As a result, certain oligosaccharides (types of sugar) build up in the body and cause damage. The active substance in Lamzede, velmanase alfa, acts in the same way as alpha-mannosidase. In this way, Lamzede preventsworsening of some body functions (such as breathing and movement) caused by the build-up of oligosaccharides.

What benefits of Lamzede have been shown in studies?

One main study involving 25 patients with alpha-mannosidosis found Lamzede more effective than placebo (a dummy treatment) at treating non-neurological effects of alpha-mannosidosis. Two main measures of effectiveness were used: a change in the level of oligosaccharides in patients' blood after a year of treatment and physical endurance measured as a change in the number of steps the patient could climb on a staircase. The levels of oligosaccharides decreased, on average, three times as much in patients receiving Lamzede compared with those receiving placebo. After treatment for one year, patients receiving Lamzede could climb about half a step more in 1 minute than they could previously, while patients receiving placebo could climb two steps less.

What are the risks associated with Lamzede?

The most common side effects with Lamzede (which may affect up to 1 in 10 people) are weight gain, infusion-related reactions (such as allergic reactions, nausea, vomiting, fever, chills, feeling unwell and itchiness), diarrhoea, headache, joint pain, pain in the arms and legs and increased appetite.For the full list of side effects and restrictions with Lamzede, see the package leaflet.

Why is Lamzede authorised in the EU?

The European Medicines Agency decided that Lamzede's benefits are greater than its risks and it can be authorised for use in the EU. Lamzede lowers the levels of oligosaccharides in the blood and it is better than placebo at slowing down the worsening of many disease effects. The Agency noted that the medicine does not appear to reach the brain and it does not improve effects such as loss of hearing or loss of control over movement. Lamzede's side effects are manageable.Lamzede has been authorised under 'exceptional circumstances'. This is because it has not been possible to obtain complete information about Lamzede due to the rarity of the disease. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Lamzede?

Since Lamzede has been authorised under exceptional circumstances, the company that markets the medicine will set up a registry of patients treated with Lamzede and provide additional information on the long-term effectiveness and safety of the medicine as well as the medicine's effects on variants of the condition. The company will also provide results of a 2-year study looking at the safety and effectiveness of Lamzede in children aged up to 6 years.

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

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

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Lantus

What is Lantus?

Lantus is a solution for injection that contains the active substance insulin glargine. It is available as vials, cartridges and prefilled disposable pens (OptiSet and SoloStar).

What is Lantus used for?

Lantus is used to treat diabetes in patients aged two years or older.The medicine can only be obtained with a prescription.

How is Lantus used?

Lantus is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected. The patient's blood glucose (sugar) should be regularly tested to find the lowest effective dose.Lantus is given once a day. In adults (aged 18 years or over), it can be given at any time, provided that it is at the same time each day. It should be given in the evening in patients aged less than 18 years. Lantus can also be given together with antidiabetes medicines taken by mouth in patients who have type 2 diabetes.Patients can inject themselves with Lantus if they have been trained appropriately.

How does Lantus work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Lantus is a replacement insulin that is very similar to the insulin made by the body.The active substance in Lantus, insulin glargine, is produced by a method known as 'recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glargine.Insulin glargine is very slightly different from human insulin. The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Lantus been studied?

Lantus was originally studied in 10 studies, in both type 1 diabetes (when the pancreas cannot produce insulin) and type 2 diabetes (when the body is unable to use insulin effectively). A total of 2,106 patients received Lantus in all trials combined. The main studies compared Lantus given once a day at bedtime with human insulin NPH (an intermediate-acting insulin) given once or twice a day. Injections of fast-acting insulin were also used at mealtimes. In one study, patients with type 2 diabetes also received antidiabetes medicines by mouth.Further studies have also been carried out to compare Lantus and human insulin NPH in patients with type 1 diabetes aged between five and 18 years, 200 of whom received Lantus, and in children aged two to six years, 61 of whom received Lantus.Studies have also been carried out in nearly 1,400 adults with type 1 or type 2 diabetes to measure the effectiveness of Lantus injected at any time during the day, compared with an injection given in the evening.All of the studies measured the level of 'fasting' blood glucose (measured when the patients had not eaten for at least eight hours) or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

What benefit has Lantus shown during the studies?

Lantus led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with human insulin. Lantus was effective in managing diabetes in adults and children aged two years and above. The effectiveness of Lantus was seen regardless of the time of the injection.

What is the risk associated with Lantus?

The most common side effect with Lantus (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults. For the full list of all side effects reported with Lantus, see the package leaflet.Lantus must not be used in people who are hypersensitive (allergic) to insulin glargine or to any of the other ingredients. Lantus doses might also need to be adjusted when given with some other medicines that may have an effect on blood glucose levels. The full list is available in the package leaflet.

Why has Lantus been approved?

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

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Latuda

What is Latuda and what is it used for?

Latuda is a medicine that is used to treat patients from 13 years of age with schizophrenia, a mental illness with symptoms that include disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).Latuda contains the active substance lurasidone.

How is Latuda used?

Latuda can only be obtained with a prescription and in patients aged under 18 years it should be prescribed by an expert on mental illness in children. Latuda is available as tablets to take by mouth.The recommended starting dose is 37 mg once a day, taken with food at around the same time each day. The doctor will then adjust the dose according to how well the condition is being controlled, up to a maximum dose of 148 mg once a day in adults and 74 mg once a day in younger patients.For more information about using Latuda, see the package leaflet or contact your doctor or pharmacist.

How does Latuda work?

The active substance in Latuda, lurasidone, is an antipsychotic medicine. It works at several different receptors (targets) for neurotransmitters on nerve cells in the brain. Neurotransmitters are chemicals that allow nerve cells to communicate with each other.Lurasidone acts mainly by blocking the receptors for the neurotransmitters dopamine, 5hydroxytryptamine (also called serotonin) and noradrenaline. Since these neurotransmitters play a role in schizophrenia, by blocking their receptors lurasidone helps to normalise the activity of the brain, reducing symptoms.

What benefits of Latuda have been shown in studies?

Latuda has been investigated in six main studies. Three short-term studies compared Latuda with placebo (a dummy treatment) over 6 weeks in a total of 1,466 adults. The main measure of effectiveness was the change in symptoms, measured using a standard scale for schizophrenia called'positive and negative syndrome scale' (PANSS). In these studies, Latuda was found to be more effective than placebo, lowering the PANSS score by up to 16 points more than placebo; however, this effect was not consistent for each dose studied and it was not possible to see a consistent pattern of greater improvement with higher doses. Further analyses of the results by the company supported the likelihood of short-term benefits of treatment with Latuda.One of the short-term studies was continued to 12 months to look at the effect of continuing use of Latuda in 292 adults, compared with the medicine quetiapine; two other studies, involving 914 adults, looked at the long-term effects of Latuda compared with another schizophrenia medicine, risperidone, or with placebo. In these long-term studies, effectiveness was measured in terms of the percentage of patients whose condition worsened, and whose symptoms came back during treatment. In the extension study, Latuda was at least as effective as quetiapine, with the condition worsening in 21% of patients treated with Latuda within 1 year, compared with 27% of patients treated with quetiapine. Latuda was not found to be as effective as risperidone in the second study but the available data supported a long-term benefit. The last study showed that the condition worsened in 30% of patients treated with Latuda within one year, compared with 41% of patients receiving placebo.A further study involved 326 patients aged 13 to 17 years with schizophrenia whose symptoms had worsened markedly in the previous 2 months. After 6 weeks, PANSS scores improved by over 18 points in patients taking Latuda compared with an improvement of 10.5 points in those receiving placebo. Continuing use of Latuda for up to 2 years led to further improvement in PANSS scores.

What are the risks associated with Latuda?

The most common side effects with Latuda (which may affect more than 1 in 10 people) are akathisia (a constant urge to move) and sleepiness.Latuda must not be used together with medicines considered to be 'strong CYP3A4 inhibitors' or 'strong CYP3A4 inducers', which may affect the levels of lurasidone in the blood.For the full list of side effects and restrictions of Latuda, see the package leaflet.

Why is Latuda authorised in the EU?

Studies have found Latuda to be effective for treating schizophrenia in patients aged from 13 years in both the short-term and long-term, but its effectiveness was moderate in short-term studies. The European Medicines Agency noted that treatment options for adolescents with schizophrenia are limited. The side effects of Latuda were similar to those of other medicines of the same type, but it seemed to have fewer effects on body metabolism (such as effects on blood levels of sugar and fat, and body weight) and might have less effect on the activity of the heart than some other available treatments.The Agency therefore decided that Latuda'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 Latuda?

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

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Laventair Ellipta

What is Laventair Ellipta and what is it used for?

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

How is Laventair Ellipta used?

Laventair Ellipta can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device. Each inhalation provides 65 micrograms of umeclidinium bromide (equivalent to 55 micrograms of umeclidinium) and 22 micrograms of vilanterol.The recommended dose is one inhalation per day at the same time each day. For detailed information on using the inhaler correctly, see the instructions in the package leaflet or contact your doctor and pharmacist.

How does Laventair Ellipta work?

Laventair Ellipta contains two active substances. Vilanterol is a long-acting beta-2 agonist. It works by attaching to beta-2 receptors found in the muscle cells of many organs including the airways in the lungs. When inhaled, vilanterol reaches the receptors in the airways and activates them. This relaxes the muscles of the airways.Umeclidinium bromide is a muscarinic receptor antagonist. It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles. When umeclidinium bromide is inhaled, it relaxes the muscles of the airways.The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily. Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.1 Previously known as Laventair.

What benefits of Laventair Ellipta have been shown in studies?

Laventair Ellipta and a higher-dose combination of umeclidinium bromide and vilanterol were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium bromide alone and another COPD medicine called tiotropium in 4 main studies.In all 4 studies, involving over 4,700 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).Results showed that Laventair Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment. Laventair Ellipta also increased FEV1 by an average of 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone. The average increase in FEV1 with Laventair Ellipta was 90 ml more than with tiotropium after 24 weeks of treatment.Laventair Ellipta was also shown to improve symptoms such as breathlessness and wheezing.The results for the higher dose combination of umeclidinium bromide and vilanterol did not consistently show relevant improvements in lung function to justify its use.

What are the risks associated with Laventair Ellipta?

The most common side effects with Laventair Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.For the full list of side effects and restrictions, see the package leaflet.

Why is Laventair Ellipta authorised in the EU?

The European Medicines Agency decided that Laventair Ellipta's benefits are greater than its risks and recommended that it can be authorised for use in the EU. The Agency concluded that Laventair Ellipta was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium. The Agency also noted that there were no major safety concerns with Laventair Ellipta, with side effects being manageable, although the longterm safety data so far are limited. To investigate this further the Agency recommended that a study be carried out.

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

As medicines of the same class as Laventair Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets the medicine will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.Recommendations and precautions to be followed by healthcare professionals and patients have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Laventair Ellipta are continuously monitored. Side effects reported with Laventair Ellipta are carefully evaluated and any necessary action taken to protect patients.Laventair Ellipta0F (umeclidinium bromide / vilanterol)

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Ledaga

What is Ledaga and what is it used for?

Ledaga is a medicine used to treat adults with a skin cancer called mycosis fungoides-type cutaneous T-cell lymphoma. The medicine contains the active substance chlormethine.Because the number of patients with this skin cancer is low, the disease is considered 'rare', and Ledaga was designated an 'orphan medicine' (a medicine used in rare diseases) on 22 May 2012.Ledaga is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' (in this case Caryolysine) containing the same active substance and used for the same purpose. The difference between Ledaga and Caryolysine is that Ledaga is available as a gel and Caryolysine was available as a liquid for diluting before applying to the skin.

How is Ledaga used?

Ledaga can only be obtained with a prescription. Treatment with Ledaga should be started by a doctor with appropriate experience.Ledaga, which is available as a gel, is applied as a thin film to the affected areas of the skin once aday. It has to be applied with care to stop it getting on areas not affected by the disease. Treatment should be stopped if patients develop blisters or open sores. For further information, see the package leaflet.

How does Ledaga work?

The active substance in Ledaga, chlormethine, belongs to the group of cancer medicines called 'alkylating agents'. Alkylating agents work by attaching to the DNA of cells while the cells are dividing. As a result, cancer cells cannot divide and they eventually die.

What benefits of Ledaga have been shown in studies?

The company provided data from the published literature showing that chlormethine, the active substance in Ledaga, is effective in treating mycosis fungoides-type cutaneous T-cell lymphoma.In addition, a study involving 260 patients found that Ledaga was at least as effective as an ointment containing the same amount of chlormethine. The ointment's effectiveness was considered comparable to that of the reference medicine, Caryolysine. Effectiveness was measured as complete or partial improvement in the 'CAILS' score, which takes into account different features of the cancer, such as the size and appearance of the skin damage. Ledaga was effective in 58% of patients (76 patients out of 130) after at least 6 months of treatment compared with 48% of patients (62 out of 130) using the ointment.

What are the risks associated with Ledaga?

The most common side effects with Ledaga (which may affect more than 1 in 10 people) are dermatitis (skin inflammation with reddening, rash, pain and burning sensation), skin infection and itching. For the full list of side effects and restrictions, see the package leaflet.

Why is Ledaga approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ledaga has shown comparable safety and effectiveness to Caryolysine and has shown satisfactory quality. Therefore, the CHMP's view was that, as for Caryolysine, the benefits outweigh the identified risks. The Committee recommended that Ledaga be approved for use in the EU.

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

The company that markets Ledaga will supply materials to prevent accidental contact with the medicine, especially in the eye and the inside of the nose and mouth. The materials will include a sealable, child-resistant plastic bag for safely storing the medicine in a refrigerator, together with a patient alert card with instructions on the correct way to apply the medicine.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ledaga have also been included in the summary of product characteristics and the package leaflet.

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Leflunomide Medac

What is Leflunomide medac?

Leflunomide medac is a medicine that contains the active substance leflunomide. It is available as tablets (10, 15 and 20 mg).Leflunomide medac is a 'generic medicine'. This means that Leflunomide medac is similar to a 'reference medicine' already authorised in the European Union (EU) called Arava. For more information on generic medicines, see the question-and-answer document here.

What is Leflunomide medac used for?

Leflunomide medac is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).The medicine can only be obtained with a prescription.

How is Leflunomide medac used?

Leflunomide medac treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide medac, and regularly during treatment.Leflunomide medac treatment usually starts with a 'loading dose' of 100 mg once a day for three days, followed by a maintenance dose. The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The medicine usually starts to have an effect after four to six weeks. Its effect may improve further for up to six months.

How does Leflunomide medac work?

The active substance in Leflunomide medac, leflunomide, is an immunosuppressant. It reduces inflammation by reducing the production of immune cells called 'lymphocytes', which are responsible for inflammation. Leflunomide does this by blocking an enzyme called 'dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply. With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.

How has Leflunomide medac been studied?

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

What are the benefit and risk of Leflunomide medac?

Because Leflunomide medac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.

Why has Leflunomide medac been approved?

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

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

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

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Leflunomide Ratiopharm

What is Leflunomide ratiopharm?

Leflunomide ratiopharm is a medicine that contains the active substance leflunomide. It is available as white round tablets (10 and 20 mg).Leflunomide ratiopharm is a 'generic medicine'. This means that Leflunomide ratiopharm is similar to a 'reference medicine' already authorised in the European Union (EU) called Arava. For more information on generic medicines, see the question-and-answer document here.

What is Leflunomide ratiopharm used for?

Leflunomide ratiopharm is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).The medicine can only be obtained with a prescription.

How is Leflunomide ratiopharm used?

Leflunomide ratiopharm treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide ratiopharm, and regularly during treatment.Send a questioLeflunomide ratiopharm treatment starts with a 'loading dose' of 100 mg once a day for three days, followed by a maintenance dose. The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The medicine usually starts to have an effect after four to six weeks. Its effect may improve further for up to six months.

How does Leflunomide ratiopharm work?

The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant. It reduces inflammation by reducing the production of immune cells called 'lymphocytes', which are responsible for inflammation. Leflunomide does this by blocking an enzyme called 'dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply. With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.

How has Leflunomide ratiopharm been studied?

The applicant presented data on experimental models from the scientific literature.Because Leflunomide ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Leflunomide ratiopharm?

Because Leflunomide ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.

Why has Leflunomide ratiopharm been approved?

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

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Leflunomide Zentiva

What is Leflunomide Zentiva and what is it used for?

Leflunomide Zentiva is a medicine used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints). The medicine contains the active substance leflunomide.

How is Leflunomide Zentiva used?

Leflunomide Zentiva is available as tablets (10 mg, 20 mg and 100 mg). It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide Zentiva, and regularly during treatment.Leflunomide Zentiva treatment usually starts with a 'loading dose' of 100 mg once a day for 3 days, followed by a maintenance dose. The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The medicine usually starts to have an effect after 4 to 6 weeks. Its effect may improve further for up to 6 months.For more information about using Leflunomide Zentiva, see the package leaflet or contact your doctor or pharmacist.

How does Leflunomide Zentiva work?

The active substance in Leflunomide Zentiva, leflunomide, is an immunosuppressant. It reduces inflammation by reducing the production of immune cells called 'lymphocytes', which are responsible for inflammation. Leflunomide does this by blocking an enzyme called 'dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply. With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.1 Previously known as Leflunomide Winthrop.

What benefits of Leflunomide Zentiva have been shown in the studies?

Rheumatoid arthritisIn rheumatoid arthritis, Leflunomide Zentiva has been studied in 4 main studies involving over 2,000 patients, in which it was compared with placebo (a dummy treatment), or with methotrexate or sulphasalazine (other medicines used to treat rheumatoid arthritis). Two of the studies lasted 6 months, and two lasted 1 year. The two longer studies were then extended, with patients remaining on the medicines for at least 1 more year.Results showed that Leflunomide Zentiva was more effective than placebo and as effective as sulphasalazine. Between 49 and 55% of the patients taking Leflunomide Zentiva responded to treatment, compared with 26 to 28% of those taking placebo, and 54% of those taking sulphasalazine. These results were maintained in the extension studies. Over the first year of treatment, Leflunomide Zentiva was as effective as methotrexate, but only when it was taken with folate (a type of vitamin B). Leflunomide Zentiva was not as effective as methotrexate in the extension study.Psoriatic arthritisIn psoriatic arthritis, a study in 186 patients showed that Leflunomide Zentiva was more effective than placebo over 6 months: 59% of the patients taking Leflunomide Zentiva responded to treatment, compared with 30% of those taking placebo.

What are the risks associated with Leflunomide Zentiva?

The most common side effects with Leflunomide Zentiva (which may affect up to 1 in 10 people) are leucopenia (low white blood cell counts), mild allergic reactions, increased creatine phosphokinase levels (a marker of muscle damage), paraesthesia (abnormal sensations like pins and needles), peripheral neuropathy (nerve damage in hands and feet), headache, dizziness, mild increases in blood pressure, colitis (inflammation in the large bowel), diarrhoea, nausea (feeling sick), vomiting, inflammation of the mouth such as mouth ulcers, abdominal (belly) pain, increased liver enzyme levels, hair loss, eczema, rash, pruritus (itching), dry skin, tenosynovitis (inflammation of the sheath surrounding the tendons), loss of appetite, weight loss and asthenia (weakness). For the full list of side effects with Leflunomide Zentiva, see the package leaflet.Leflunomide Zentiva must not be used in patients with:• liver disease;• severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);• poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis;• serious infections;• moderate to severely impaired kidney function;• severe hypoproteinaemia (low blood protein levels).Leflunomide Zentiva must not be used in pregnant women, in women who can become pregnant and who are not using reliable contraception or during breast-feeding.For the full list of restrictions, see the package leaflet.Leflunomide Zentiva0F (leflunomide)Doctors prescribing Leflunomide Zentiva need to be aware of the risk of liver problems associated with the medicine. They also need to take special care when switching a patient to Leflunomide Zentiva, or when switching a patient who is receiving Leflunomide Zentiva to another treatment.

Why is Leflunomide Zentiva authorised in the EU?

The European Medicines Agency decided that Leflunomide Zentiva'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 Leflunomide Zentiva?

The company that markets Leflunomide Zentiva will ensure that doctors who are expected to prescribethe medicine receive an information pack containing important information on the risks with Leflunomide Zentiva and the monitoring that should be carried out in patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Leflunomide Zentiva have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Leflunomide Zentiva are continuously monitored. Side effects reported with Leflunomide Zentiva are carefully evaluated and any necessary action taken to protect patients.

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Lemtrada

What is Lemtrada and what is it used for?

Lemtrada is a medicine that is used to treat adults with relapsing-remitting multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves as well as the nerves themselves. 'Relapsing-remitting' means that the patient has attacks (relapses) between periods with few or no symptoms (remissions).Lemtrada is used for patients with:• disease that is highly active, even though they have been treated with a disease-modifying therapy;• rapidly worsening, severe disease, who have had 2 or more relapses in one year and whose brain scans show certain brain lesions.Lemtrada contains the active substance alemtuzumab.

How is Lemtrada used?

Lemtrada can only be obtained with a prescription. Treatment should only be started and supervised by a neurologist experienced in treating MS. It should be given in a hospital with access to intensive care, as well as equipment and specialist staff for managing serious reactions and side effects that can occur with Lemtrada. Patients should receive certain medicines before or during treatment to reduce the side effects.Lemtrada is given as an infusion (drip) into a vein over about 4 hours. It is initially given in two courses of treatment: a first course of 12 mg daily for 5 days, followed 12 months later by a second course of 12 mg daily for 3 days. Up to two additional courses, each of 12 mg daily for 3 days, can be given at 12-month intervals.For more information about using Lemtrada, see the package leaflet or contact your doctor or pharmacist.

How does Lemtrada work?

In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them. The active substance in Lemtrada, alemtuzumab, is a type of protein called a monoclonal antibody that has been designed to attach to another protein called CD52. CD52 is found on lymphocytes, white blood cells that are part of the immune system. When alemtuzumab attaches to the lymphocytes, it causes them to die, and they are replaced by new lymphocytes. The way alemtuzumab acts in multiple sclerosis is not fully understood, but it is believed that its effect on lymphocytes reduces the immune system's damaging activity.

What benefits of Lemtrada have been shown in studies?

Lemtrada has been studied in two main studies involving 1,421 patients with relapsing-remitting multiple sclerosis. In both studies, Lemtrada was compared with another medicine for multiple sclerosis, interferon beta-1a. The first study involved previously untreated patients, while the second study involved patients whose disease had relapsed despite treatment. In both studies, the main measure of effectiveness was based on the number of relapses the patients had each year and the progression of disability after two years of treatment.In the first study, the average number of relapses per year in patients given Lemtrada was less than half the number in patients given interferon beta-1a (0.18 versus 0.39), but there was no meaningful effect in terms of progression of disability. In the second study, the average number of relapses per year in patients given Lemtrada was half the number in patients given interferon beta-1a (0.26 versus 0.52), and around 13% of patients given Lemtrada had a sustained progression of disability compared with around 21% of patients given interferon beta-1a.Patients involved in the two main studies were followed-up for at least four years in an extension study, during which they were given up to two additional doses of Lemtrada, at one-year intervals, if their disease progressed. Over half of patients included in the extension study did not have disease progression and did not need additional Lemtrada infusions. For those patients who needed one or two additional infusions with Lemtrada, the number of relapses was lower, and disability progression was slower, compared with the previous year.

What are the risks associated with Lemtrada?

The most important side effects with Lemtrada are autoimmune conditions (where the body's defence system attacks normal tissue), including thyroid gland disorders, immune thrombocytopenic purpura (a bleeding disorder caused by low blood platelet counts) and kidney damage, as well as low blood cell counts, reactions to the infusion and infections. The most common side effects with Lemtrada (which may affect more than 1 in 5 people) are rash, headache, fever and respiratory tract infections (throat and chest infections). For the full list of side effects of Lemtrada, see the package leaflet.Lemtrada must not be used in patients with HIV and in patients with severe infections. It must not be used in patients with uncontrolled hypertension (high blood pressure), patients who have had arterial dissection (tears) of the cervicocephalic arteries (blood vessels in the head and neck), stroke, angina pectoris (pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart) or myocardial infarction (heart attack). Lemtrada must not be used in patients with coagulopathy (problems with blood clotting) or in patients who are taking anti-platelet or anti-coagulant therapy. The medicine must not be used in patients with autoimmune diseases besides MS.For the full list of restrictions, see the package leaflet.

Why is Lemtrada authorised in the EU?

The European Medicines Agency decided that Lemtrada's benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that studies have shown the benefit for patients with highly active disease and rapidly worsening severe disease. With regards to safety, Lemtrada has rare but serious side effects, including disorders of the heart, blood vessels and immune system and measures have been put in place to minimise this risk.1

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

The company that markets Lemtrada will carry out studies on the safety of the medicine and to assess whether the medicine is used according to the latest recommendations.The company will ensure that doctors expected to prescribe the medicine receive educational materials containing important safety information, and a checklist covering the necessary screening, medicines to reduce side effects, monitoring before, during and after infusion, and long-term monitoring of patients. Patients will receive a patient alert card and a guide explaining the risks with the medicine and symptoms of Lemtrada's serious side effects.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lemtrada have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lemtrada are continuously monitored. Side effects reported with Lemtrada are carefully evaluated and any necessary action taken to protect patients.

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Lenalidomide Accord

What is Lenalidomide Accord and what is it used for?

Lenalidomide Accord is a medicine used for the treatment of multiple myeloma (cancer of a type of white blood cells called plasma cells) and follicular lymphoma (cancer of another type of white blood cells called B lymphocytes).In multiple myeloma, Lenalidomide Accord is used:• in adults who have had a stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor);• in adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;• in adults whose disease has been treated at least once. It is used in combination with dexamethasone.In follicular lymphoma, Lenalidomide Accord is used in adults who have already been treated for their disease. It is used with the medicine rituximab.Lenalidomide Accord is a 'generic medicine'. This means that Lenalidomide Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document here.

How is Lenalidomide Accord used?

Lenalidomide Accord is available as capsules of various strengths to be taken by mouth. The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.Treatment is given in cycles, with Lenalidomide Accord being used once a day on certain days of the cycles. Treatment cycles are continued until the disease is no longer being controlled or side effects become unacceptable. The dose of Lenalidomide Accord depends on the disease it is being used for,the patient's overall health and blood test results. The dose may need to be reduced or treatment interrupted in case of certain side effects.For more information about using Lenalidomide Accord, see the package leaflet or contact your doctor or pharmacist.

How does Lenalidomide Accord work?

The active substance in Lenalidomide Accord, lenalidomide, is an immunomodulator. This means that it affects the activity of the immune system (the body's natural defences). Lenalidomide works in several ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.

How has Lenalidomide Accord been studied?

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

Because Lenalidomide 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 Lenalidomide Accord authorised in the EU?

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

The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards to patients about the safety measures patients should take.The company has also set up a pregnancy prevention programme in each Member State and will collect information on the medicine's use outside its authorised uses. The boxes containing Lenalidomide Accord capsules also include a warning stating that lenalidomide can be harmful to the unborn child.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Accord have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lenalidomide Accord are continuously monitored. Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients.

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Lenalidomide Krka

What is Lenalidomide Krka and what is it used for?

Lenalidomide Krka is a medicine used for the treatment of certain cancers and serious conditions affecting blood cells and bone marrow, namely multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma.In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka is used:• in adults with previously untreated (newly diagnosed) multiple myeloma, who have had an autologous stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced with the patient's own stem cells to form new bone marrow);• in adults with previously untreated multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;• in adults whose disease has been treated at least once. It is used in combination with dexamethasone.In myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood cell counts), Lenalidomide Krka is used in patients who need blood transfusions to manage their anaemia. It is used in patients with a genetic change (called deletion 5q) when other treatments are not adequate.In mantle cell lymphoma and follicular lymphoma, blood cancers that affect a type of white blood cell called B lymphocytes, Lenalidomide Krka is used in adults whose disease has come back after treatment or does not improve with treatment. In follicular lymphoma it is used in combination with rituximab.Lenalidomide Krka contains the active substance lenalidomide and is a 'generic medicine'. This means that Lenalidomide Krka contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document here.Send

How is Lenalidomide Krka used?

Lenalidomide Krka can only be obtained with a prescription and treatment should be supervised by doctors who have experience in the use of cancer medicines.Lenalidomide Krka is available as capsules of various strengths to be taken by mouth. Treatment is given in cycles, with the medicine being used once a day on certain days of the cycles. Treatment cycles are continued until the disease is no longer being controlled or side effects become unacceptable. The dose depends on the disease it is being used for, the patient's overall health and blood test results. The dose may need to be reduced or treatment interrupted in case of certain side effects.For more information about using Lenalidomide Krka, see the package leaflet or contact your doctor or pharmacist.

How does Lenalidomide Krka work?

The active substance in Lenalidomide Krka, lenalidomide, is an immunomodulator. This means that it affects the activity of the immune system (the body's natural defences). Lenalidomide works in several ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and stimulates specialised cells of the immune system to attack the abnormal cells.

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

Because Lenalidomide 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 Lenalidomide Krka authorised in the EU?

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

The company that markets Lenalidomide Krka will provide educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards to patients about the safety measures patients should take.The company has also set up a pregnancy prevention programme and will collect information on the medicine's use outside its authorised uses. The boxes containing Lenalidomide Krka capsules also include a warning stating that lenalidomide can be harmful to the unborn child.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Krka have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lenalidomide Krka are continuously monitored. Side effects reported with Lenalidomide Krka are carefully evaluated and any necessary action taken to protect patients.

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Lenalidomide Krka D.D. Novo Mesto

What is Lenalidomide Krka d.d. Novo mesto and what is it used for?

Lenalidomide Krka d.d. Novo mesto is a medicine used for the treatment of certain cancers affecting blood cells, namely multiple myeloma and follicular lymphoma.In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka d.d. Novo mesto is used:• in adults with previously untreated (newly diagnosed) multiple myeloma, who have had an autologous stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced with the patient's own stem cells to form new bone marrow);• in adults with previously untreated multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;• in adults whose disease has been treated at least once. It is used in combination with dexamethasone.In follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Krka d.d. Novo mesto is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab.Lenalidomide Krka d.d. Novo mesto contains the active substance lenalidomide and is a 'generic medicine'. This means that Lenalidomide Krka d.d. Novo mesto contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document here.

How is Lenalidomide Krka d.d. Novo mesto used?

Lenalidomide Krka d.d. Novo mesto can only be obtained with a prescription and treatment should be supervised by doctors who have experience in the use of cancer medicines.Lenalidomide Krka d.d. Novo mesto is available as capsules of various strengths to be taken by mouth.Treatment is given in cycles, with the medicine being used once a day on certain days of the cycles.SendTreatment cycles are continued until the disease is no longer being controlled or side effects become unacceptable. The dose depends on the disease it is being used for, the patient's overall health and blood test results. The dose may need to be reduced or treatment interrupted in case of certain side effects.For more information about using Lenalidomide Krka d.d. Novo mesto, see the package leaflet or contact your doctor or pharmacist.

How does Lenalidomide Krka d.d. Novo mesto work?

The active substance in Lenalidomide Krka d.d. Novo mesto, lenalidomide, is an immunomodulator.This means that it affects the activity of the immune system (the body's natural defences).Lenalidomide works in several ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and stimulates specialised cells of the immune system to attack the abnormal cells.

How has Lenalidomide Krka d.d. Novo mesto 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, Revlimid, and do not need to be repeated for Lenalidomide Krka d.d. Novo mesto.As for every medicine, the company provided studies on the quality of Lenalidomide Krka d.d. Novo mesto. 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 Lenalidomide Krka d.d. Novo mesto?

Because Lenalidomide Krka d.d. Novo mesto 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 Lenalidomide Krka d.d. Novo mesto authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, LenalidomideKrka d.d. Novo mesto has been shown to have comparable quality and to be bioequivalent to Revlimid. Therefore, the Agency's view was that, as for Revlimid, the benefits of Lenalidomide Krka d.d. Novo mesto 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 Lenalidomide Krka d.d. Novo mesto?

The company that markets Lenalidomide Krka d.d. Novo mesto will provide educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards to patients about the safety measures patients should take.The company has also set up a pregnancy prevention programme and will collect information on the medicine's use outside its authorised uses. The boxes containing Lenalidomide Krka d.d. Novo mesto capsules also include a warning stating that lenalidomide can be harmful to the unborn child.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Krka d.d. Novo mesto have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lenalidomide Krka d.d. Novo mesto are continuously monitored. Side effects reported with Lenalidomide Krka d.d. Novo mesto are carefully evaluated and any necessary action taken to protect patients.

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Lenalidomide Mylan

What is Lenalidomide Mylan and what is it used for?

Lenalidomide Mylan is a medicine used for the treatment of certain cancers affecting blood cells, namely multiple myeloma and follicular lymphoma.In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Mylan is used:• in adults with previously untreated (newly diagnosed) multiple myeloma, who have had a stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor);• in adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;• in adults whose disease has been treated at least once. It is used in combination with dexamethasone.In follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Mylan is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab.Lenalidomide Mylan contains the active substance lenalidomide and is a 'generic medicine'. This means that Lenalidomide Mylan contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document here.

How is Lenalidomide Mylan used?

Lenalidomide Mylan can only be obtained with a prescription and treatment should be supervised by doctors who have experience in the use of cancer medicines.Lenalidomide Mylan is available as capsules of various strengths to be taken by mouth. Treatment is given in cycles, with the medicine being used once a day on certain days of the cycles. Treatment cycles are continued until the disease is no longer being controlled or side effects becomeSendunacceptable. The dose depends on the disease it is being used for, the patient's overall health and blood test results. The dose may need to be reduced or treatment interrupted in case of certain side effects.For more information about using Lenalidomide Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Lenalidomide Mylan work?

The active substance in Lenalidomide Mylan, lenalidomide, is an immunomodulator. This means that it affects the activity of the immune system (the body's natural defences). Lenalidomide works in several ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.

How has Lenalidomide Mylan 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, Revlimid, and do not need to be repeated for Lenalidomide Mylan.As for every medicine, the company provided studies on the quality of Lenalidomide Mylan. The company also carried out studies that showed that it is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Lenalidomide Mylan?

Because Lenalidomide 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 Lenalidomide Mylan authorised in the EU?

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

The company that markets Lenalidomide Mylan will provide educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards to patients about the safety measures patients should take.The company has also set up a pregnancy prevention programme in each member state and will collect information on the medicine's use outside its approved uses. The boxes containing Lenalidomide Mylan capsules also include a warning stating that lenalidomide can be harmful to the unborn child.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Mylan have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lenalidomide Mylan are continuously monitored. Side effects reported with Lenalidomide Mylan are carefully evaluated and any necessary action taken to protect patients.

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Lenvima

What is Lenvima and what is it used for?

Lenvima is a cancer medicine used to treat adults with:• differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland. Lenvima is used on its own when the cancer has progressed or spread locally or to other parts of the body, and does not respond to treatment with radioactive iodine;• hepatocellular carcinoma (a type of liver cancer). It is used on its own in patients who did not previously receive a cancer medicine by mouth or by injection and whose cancer is advanced or cannot be removed by surgery;• endometrial carcinoma (cancer of the lining of the womb). It is used together with another cancer medicine, pembrolizumab, in patients whose disease is advanced or has come back after previous treatment involving platinum-based cancer medicines, when surgery or radiation to cure the cancer is not possible.Lenvima contains the active substance lenvatinib.

How is Lenvima used?

Lenvima can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.The medicine is available as capsules to be taken by mouth once daily. The recommended dose depends on the condition being treated. Treatment is continued as long as the patient continues to benefit from it without too many side effects.To manage side effects, the doctor may decide to reduce the dose or stop treatment temporarily. In certain cases treatment should be permanently stopped.For more information about using Lenvima, see the package leaflet or contact your doctor or pharmacist.

How does Lenvima work?

The active substance in Lenvima, lenvatinib, is a tyrosine-kinase inhibitor. This means that it blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in certain receptors (such as VEGF, FGFR and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels. By blocking these enzymes, lenvatinib can block the formation of new blood vessels and hence cut off the blood supply that keeps cancer cells growing, and reduce their growth. Lenvatinib may also alter the activity of the immune system (the body's natural defences).

What benefits of Lenvima have been shown in studies?

Differentiated thyroid carcinomaLenvima has been shown to be more effective than placebo (a dummy treatment) at slowing down disease progression in one main study. The study involved 392 adult patients with differentiated thyroid carcinoma that had shown signs of getting worse in the previous year and did not respond to treatment with radioactive iodine. The main measure of effectiveness was how long the patients lived without their disease getting worse: in the patients taking Lenvima this was an average of 18.3 months, compared with 3.6 months in those taking placebo.Hepatocellular carcinomaLenvima has been shown to be at least as effective as the cancer medicine sorafenib at prolonging the time patients lived in one main study. The study involved 954 patients with hepatocellular carcinoma who had not previously been treated for their cancer and whose cancer could not be removed by surgery. Patients given Lenvima lived on average 13.6 months compared with 12.3 months in patients on sorafenib.Endometrial carcinomaLenvima combined with pembrolizumab has been shown to be more effective than standard treatment in a main study involving 827 patients whose cancer had got worse after platinum-based treatments. Patients lived on average 18.3 months with Lenvima plus pembrolizumab and 11.4 months with standard treatment; the time patients lived without their disease getting worse again was an average7.2 months and 3.8 months respectively.

What are the risks associated with Lenvima?

The most common side effects with Lenvima (which may affect more than 3 in 10 people) are hypertension (high blood pressure), diarrhoea, decreased appetite and weight, tiredness, nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), vomiting, dysphonia (hoarse voice), headache and palmar-plantar erythrodysaesthesia syndrome (PPE - rash and numbness on the palms and soles). When used in combination with pembrolizumab the most common side effects, which may affect more than 2 in 10 people, also include hypothyroidism (reduced thyroid function), arthralgia (joint pain), constipation, urinary tract infection, abdominal (belly) pain, weakness, anaemia (low red blood cell levels) and hypomagnesaemia (low levels of magnesium in the blood).The most common serious side effects include kidney failure and impairment; problems with the heart and circulation such as heart failure, blood clots in the arteries leading to stroke or heart attack, bleeding in the brain or from swollen blood vessels in the passage from mouth to stomach, a syndromeknown as 'posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision, liver failure, hepatic encephalopathy (brain damage due to liver failure), stroke and heart attack. For the full list of side effects with Lenvima, see the package leaflet.Lenvima must not be taken by breastfeeding women. For the full list of restrictions, see the package leaflet.

Why is Lenvima authorised in the EU?

The European Medicines Agency decided that Lenvima's benefits are greater than its risks and it can be authorised for use in the EU. In patients with differentiated thyroid carcinoma, the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse. In patients with advanced hepatocellular carcinoma who have a poor prognosis and few treatment options, Lenvima was as effective as sorafenib in prolonging their life. Similarly, in patients with endometrial cancer that does not respond to or comes back after platinum-based treatment, prognosis is poor, and Lenvima plus pembrolizumab offers a valuable treatment option. Regarding safety, the Agency considered that the majority of side effects with Lenvima can be adequately managed by reducing the dose or temporarily interrupting treatment; there are no unexpected safety concerns when used together with pembrolizumab.

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

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

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Leqvio

What is Leqvio and what is it used for?

Leqvio is a medicine used to reduce cholesterol in the blood. It is used in adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). It should be used with a low-fat diet.Leqvio is used in combination with a statin (a type of cholesterol-lowering medicine) when the maximum dose of the statin does not lower cholesterol levels enough. It can also be used in combination with other cholesterol-lowering medicines in patients who cannot take a statin.Leqvio contains the active substance inclisiran.

How is Leqvio used?

Leqvio is given by injection under the skin, usually in the belly but also in the upper arm or thigh. After the first injection, the next dose is given after 3 months and then it is given every 6 months.The medicine can only be obtained with a prescription. For more information about using Leqvio, see the package leaflet or contact your doctor or pharmacist.

How does Leqvio work?

Inclisiran, the active substance in Leqvio, interferes with RNA (genetic material) to limit the production of PCSK9, a protein that can increase levels of LDL-cholesterol ('bad' cholesterol). By preventing PCSK9 production, Leqvio helps to lower LDL-cholesterol levels.

What benefits of Leqvio have been shown in studies?

Three main studies involving a total of 3,660 patients found Leqvio effective at lowering levels of LDLcholesterol. Over 94% of patients in the studies were also taking statins or other medicines to lower the levels of lipids (fats) in blood.The studies included patients with a form of hypercholesterolaemia that runs in families and patients with raised LDL-cholesterol who either had atherosclerotic cardiovascular disease (where fatty deposits have built up in blood vessels) or were prone to atherosclerotic cardiovascular disease. After 510 days(around 15 months), the results were similar for all studies, and overall, LDL-cholesterol had dropped by over 50% in patients treated with Leqvio compared with those receiving placebo (a dummy treatment).

What are the risks associated with Leqvio?

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

Why is Leqvio authorised in the EU?

Studies have found worthwhile reductions in LDL-cholesterol levels in patients treated with Leqvio, which go beyond reductions attained with statins or other lipid-lowering medicines. There is no direct evidence yet that Leqvio reduces heart attacks or stroke but reduction in LDL-cholesterol is linked to reduction in atherosclerotic cardiovascular disease. The side effects of Leqvio are manageable.The European Medicines Agency therefore decided that Leqvio'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 Leqvio?

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

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Levemir

What is Levemir?

Levemir is a solution for injection that contains the active substance insulin detemir. It is available in cartridges and in pre-filled pens.

What is Levemir used for?

Levemir is used to treat diabetes in adults, adolescents and children from the age of one year.The medicine can only be obtained with a prescription.

How is Levemir used?

Levemir is given as an injection under the skin in the abdominal (tummy) wall, the thigh, the upper arm, the shoulder or the buttock. Levemir is a long-acting insulin. It can be used in the following ways:• alone as basal insulin• in combination with injections of a short- or rapid-acting insulin at mealtimes• in combination with diabetes medicines taken by mouth• in combination with a type of diabetes medicines called GLP-1 receptor agonists that are given by injection. When a GLP-1 receptor agonist is added to Levemir, the Levemir dose should be reduced, and subsequently adjusted according to the individual patient's blood glucose levels.Levemir can be given at any time of day, provided that it is the same time each day. The dose of Levemir should be adjusted according to the individual patient's blood glucose (sugar) levels, which should be regularly tested to find the lowest effective dose.

How does Levemir work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Levemir is a replacement insulin that is very similar to the insulin made by the body.Insulin detemir is very slightly different from human insulin. The change means that it is absorbed more slowly by the body, and takes longer to reach its target in the body. This means that Levemir has a long duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Levemir been studied?

Levemir has been studied in 1,575 adult patients with type 1 diabetes (when the pancreas cannot produce insulin) and over 2,500 adult patients with type 2 diabetes (when the body is unable to use insulin effectively). The studies compared Levemir with human insulin NPH (an intermediate-acting insulin) or insulin glargine (a long-acting insulin) given once or twice a day. Injections of fast-acting insulin were also used at mealtimes. In four of the six studies in type 2 diabetes, patients also received one or two antidiabetes medicines taken by mouth.Levemir has also been studied in two main studies involving 695 children and adolescents with diabetes aged 2-17 years in combination with insulin aspart and comparing it to insulin NPH.The effects of Levemir have also been studied in combination with metformin and liraglutide (a GLP-1 receptor agonist). In one study, 323 patients with type 2 diabetes whose blood glucose levels were not well controlled with metformin and liraglutide either received Levemir in addition to their treatment or continued on metformin and liraglutide alone.All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. Levemir has not been studied in children below one year of age.

What benefit has Levemir shown during the studies?

The studies showed that Levemir controls blood glucose levels in a similar manner to insulin NPH, with less risk of low blood glucose levels during the night and no associated weight gain. In combination with diabetes medicines taken by mouth, Levemir also controlled blood glucose levels in a similar manner to insulin glargine. Patients using Levemir in combination with liraglutide and metformin achieved a decrease of 0.5% in Hb1Ac compared with no decrease in patients using liraglutide and metformin alone. Additionally the weight benefit from liraglutide was sustained when adding Levemir.

What is the risk associated with Levemir?

The most common side effect with Levemir (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full list of all side effects and restrictions with Levemir, see the package leaflet.Levemir doses might need to be adjusted when given with some other medicines that may have an effect on blood glucose levels. The full list is available in the package leaflet.

Why has Levemir been approved?

The CHMP decided that Levemir'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 Levemir?

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

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Levetiracetam Accord

What is Levetiracetam Accord and what is it used for?

Levetiracetam Accord is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.Levetiracetam Accord can also be used as an add-on to other epilepsy medicines to treat:• partial-onset seizures with or without generalisation in patients from 1 month of age;• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to be inherited).Levetiracetam Accord contains the active substance levetiracetam and is a 'generic medicine'. This means that Levetiracetam Accord contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Keppra. For more information on generic medicines, see the question-and-answer document here.

How is Levetiracetam Accord used?

Levetiracetam Accord is available as tablets to be swallowed with liquid. It can only be obtained with a prescription.The usual starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. For patients aged between one month and 17 years weighing less than 50 kg, the dose depends on body weight.For more information about using Levetiracetam Accord, see the package leaflet or contact your doctor or pharmacist.

How does Levetiracetam Accord work?

The active substance in Levetiracetam Accord, levetiracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam Accord to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Accord been studied?

The company provided data from the published literature on levetiracetam. Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Keppra, and do not need to be repeated for Levetiracetam AccordAs for every medicine, the company provided data on the quality of Levetiracetam 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 Levetiracetam Accord?

Because Levetiracetam 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 Levetiracetam Accord authorised in the EU?

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

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

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Levetiracetam Actavis

What is Levetiracetam Actavis and what is it used for?

Levetiracetam Actavis is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.Levetiracetam Actavis can also be used as an add-on to other anti-epileptic medicines to treat:• partial-onset seizures with or without generalisation in patients from one month of age;• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).Levetiracetam Actavis contains the active substance levetiracetam and is a 'generic medicine'. This means that Levetiracetam Actavis contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Keppra. For more information on generic medicines, see the question-and-answer document here.

How is Levetiracetam Actavis used?

Levetiracetam Actavis is available as tablets to be swallowed with liquid. It can only be obtained with a prescription.The usual starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. For patients aged between one month and 17 years weighing less than 50 kg, the dose depends on body weight.For more information about using Levetiracetam Actavis, see the package leaflet or contact your doctor or pharmacist.Send

How does Levetiracetam Actavis work?

The active substance in Levetiracetam Actavis, levetiracetam, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam Actavis to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Actavis been studied?

The company provided data from the published literature on levetiracetam. Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Keppra, and do not need to be repeated for Levetiracetam Actavis. Because Levetiracetam Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Levetiracetam Actavis?

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

Why has Levetiracetam Actavis been approved?

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

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

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Levetiracetam Actavis Group

What is Levetiracetam Actavis Group and what is it used for?

Levetiracetam Actavis Group is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.Levetiracetam Actavis Group can also be used as an add-on to other anti-epileptic medicines to treat:• partial-onset seizures with or without generalisation in patients from one month of age;• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).Levetiracetam Actavis Group contains the active substance levetiracetam and is a 'generic medicine'. This means that Levetiracetam Actavis Group contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Keppra. For more information on generic medicines, see the question-and-answer document here.

How is Levetiracetam Actavis Group used?

Levetiracetam Actavis Group is available as a solution to be drunk (100 mg/ml).The usual starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. For patients aged between one month and 17 years weighing less than 50 kg, the dose depends on body weight.For more information about using Levetiracetam Actavis Group, see the package leaflet or contact your doctor or pharmacist.

How does Levetiracetam Actavis Group work?

The active substance in Levetiracetam Actavis Group, levetiracetam, is an epilepsy medicine. Epilepsy is caused by too much electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps levetiracetam to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Actavis Group been studied?

The company provided data from the published literature on levetiracetam. Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Keppra, and do not need to be repeated for Levetiracetam Actavis Group.As for every medicine, the company provided data on the quality of Levetiracetam Actavis Group. The company also provided information to show that there was no need for a study to show that the medicine was bioequivalent to the reference medicine, since the composition of the two medicines was comparable. 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 benefit has Levetiracetam Actavis Group shown during the studies?

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

Why is Levetiracetam Actavis Group authorised in the EU?

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

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Levetiracetam Hospira

What is Levetiracetam Hospira and what is it used for?

Levetiracetam Hospira is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one side of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.Levetiracetam Hospira can also be used as an add-on to other anti-epileptic medicines to treat:• partial-onset seizures with or without generalisation in patients from four years of age;• myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).Levetiracetam Hospira is used as an alternative for patients when oral treatment is temporarily not feasible.Levetiracetam Hospira contains the active substance levetiracetam and is a 'generic medicine'. This means that Levetiracetam Hospira contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Keppra. For more information on generic medicines, see the question-and-answer document here.

How is Levetiracetam Hospira used?

Levetiracetam Hospira is given by infusion (drip into a vein) and it can only be obtained with aprescription.The usual starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. For patients aged between 4 years and 17years weighing less than 50 kg, the dose depends on body weight.The use of Levetiracetam Hospira infusion should be temporary.For more information about using Levetiracetam Hospira, see the package leaflet or contact your doctor or pharmacist.

How does Levetiracetam Hospira work?

The active substance in Levetiracetam Hospira, levetiracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam Hospira to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Hospira been studied?

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

What are the benefits and risks of Levetiracetam Hospira?

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

Why is Levetiracetam Hospira authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, LevetiracetamHospira has been shown to be comparable to Keppra. Therefore, the Agency's view was that, as for Keppra, the benefits of Levetiracetam Hospira 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 Levetiracetam Hospira?

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

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Levetiracetam Ratiopharm

What is Levetiracetam ratiopharm and what is it used for?

Levetiracetam ratiopharm is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.Levetiracetam ratiopharm can also be used as an add-on to other anti-epileptic medicines to treat:• partial-onset seizures with or without generalisation in patients from one month of age;• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).Levetiracetam ratiopharm contains the active substance levetiracetam and is a 'generic medicine'. This means that Levetiracetam ratiopharm contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Keppra. For more information on generic medicines, see the question-and-answer document here.

How is Levetiracetam ratiopharm used?

Levetiracetam ratiopharm is available as tablets to be swallowed with liquid and an oral solution to be drunk. It can only be obtained with a prescription.The usual starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. For patients aged between one month and 17 years weighing less than 50 kg, the dose depends on body weight. For infants and children under the age of 6 years or weighing less than 25 kg, the oral solution is recommended.For more information about using Levetiracetam ratiopharm, see the package leaflet or contact your doctor or pharmacist.

How does Levetiracetam ratiopharm work?

The active substance in Levetiracetam ratiopharm, levetiracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam ratiopharm to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam ratiopharm been studied?

The company provided data from the published literature on levetiracetam. Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Keppra, and do not need to be repeated for Levetiracetam ratiopharm.Because Levetiracetam ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that the tablets are bioequivalent to the reference medicine, Keppra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. The company provided data to show that a bioequivalence study was not needed for the oral solution as the composition was sufficiently similar to the reference medicine.

What are the benefits and risks of Levetiracetam ratiopharm?

Because Levetiracetam ratiopharm 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 Levetiracetam ratiopharm authorised in the EU?

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

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

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Levetiracetam Sun

What is Levetiracetam Sun and what is it used for?

Levetiracetam Sun is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.Levetiracetam Sun can also be used as an add-on to other anti-epileptic medicines to treat:• partial-onset seizures with or without generalisation in patients from four years of age;• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).Levetiracetam Sun is used as an alternative for patients when oral treatment is temporarily not feasible.Levetiracetam Sun contains the active substance levetiracetam and is a 'generic medicine'. This means that Levetiracetam Sun contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Keppra. For more information on generic medicines, see the question-and-answer document here.

How is Levetiracetam Sun used?

Levetiracetam Sun is given by infusion (drip into a vein) and it can only be obtained with a prescription.The starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. For patients aged between 4 years and 17 years weighing less than 50 kg, the dose depends on body weight.The use of Levetiracetam Sun infusion should be temporary.For more information about using Levetiracetam Sun, see the package leaflet or contact your doctor or pharmacist.

How does Levetiracetam Sun work?

The active substance in Levetiracetam Sun, levetiracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam Sun to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Sun been studied?

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

What are the benefits and risks of Levetiracetam Sun?

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

Why is Levetiracetam Sun authorised in the EU?

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

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

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

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Levetiracetam Teva

What is Levetiracetam Teva and what is it used for?

Levetiracetam Teva is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.Levetiracetam Teva can also be used as an add-on to other epilepsy medicines to treat:• partial-onset seizures with or without generalisation in patients from 1 month of age;• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to be inherited).Levetiracetam Teva contains the active substance levetiracetam and is a 'generic medicine'. This means that Levetiracetam Teva contains the same active substance and works in the same way as a 'reference medicine' already authorised in the EU called Keppra. For more information on generic medicines, see the question-and-answer document here.

How is Levetiracetam Teva used?

Levetiracetam Teva is available as tablets to be swallowed with liquid. It can only be obtained with a prescription.The usual starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. For patients aged between one month and 17 years weighing less than 50 kg, the dose depends on body weight.For more information about using Levetiracetam Sun, see the package leaflet or contact your doctor or pharmacist.

How does Levetiracetam Teva work?

The active substance in Levetiracetam Teva, levetiracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam Teva to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Teva been studied?

The company provided data from the published literature on levetiracetam. Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Keppra, and do not need to be repeated for Levetiracetam Teva.As for every medicine, the company provided data on the quality of Levetiracetam Teva. 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 Levetiracetam Teva?

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

Why is Levetiracetam Teva authorised in the EU?

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

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

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Levitra

What is Levitra?

Levitra is a medicine that contains the active substance vardenafil. It is available as film-coated tablets (5, 10 and 20 mg) and as orodispersible tablets (10 mg). Orodispersible tablets are tablets that dissolve in the mouth.

What is Levitra used for?

Levitra is used to treat adult men (aged 18 years or over) with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Levitra to be effective, sexual stimulation is required.The medicine can only be obtained with a prescription.

How is Levitra used?

The recommended dose of Levitra is 10 mg, taken about 25 to 60 minutes before sexual activity. The orodispersible tablets must be taken without liquid. If Levitra film-coated tablets are taken with a high fat meal, the onset of activity may be delayed. The dose of the film-coated tablets may be increased to a maximum of 20 mg or decreased to 5 mg, depending on the effectiveness of treatment and any side effects.A starting dose of 5 mg should be considered for patients with mild and moderate liver problems or severe kidney problems. The dose may need to be adjusted in patients taking other medicines that block enzymes that break down Levitra. For full details, see the package leaflet.The maximum recommended dosing frequency is one film-coated tablet or orodispersible tablet per day.

How does Levitra work?

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

How has Levitra been studied?

Levitra tablets were compared with placebo (a dummy treatment) in four main studies including a total of 2,431 men with erectile dysfunction aged 20 to 83 years. One of these studies was carried out in diabetic men and another in men who had had their prostate gland removed. Two additional main studies compared orodispersible tablets with placebo in 701 men aged 21 to 84 yearsIn all of the studies, the main measure of effectiveness was the ability to get and maintain an erection. This was recorded in two questionnaires completed at home. The studies lasted 12 weeks.

What benefit has Levitra shown during the studies?

Levitra tablets and orodispersible tablets were significantly more effective than placebo for all measures in all of the studies.

What is the risk associated with Levitra?

The most common side effect with Levitra (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Levitra, see the package leaflet.Levitra must not be used in people who are hypersensitive (allergic) to vardenafil or any of the other ingredients. It must not be used when sexual activity is inadvisable, such as in men with severe heart disease. It must also not be used in patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION). Levitra must not be taken with nitrates (medicines used to treat angina).Because Levitra has not been studied in the following group patients, they must not use the medicine:• patients with severe liver disease or end-stage kidney disease requiring dialysis;• patients who have hypotension (low blood pressure);• patients who have had a stroke or a heart attack within the last six months;• patients with unstable angina and hereditary eye problems known as 'retinal degenerative disorders'.Levitra must not be taken with ketoconazole and itraconazole (used to treat fungal infections) in men over 75 years of age, or with medicines called 'HIV protease inhibitors' such as ritonavir or indinavir (used to treat HIV infection).In addition, Levitra must not be taken with medicines known as guanylate cyclase stimulators, including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).

Why has Levitra been approved?

The CHMP decided that Levitra'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 Levitra?

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

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Levodopa/Carbidopa/Entacapone Orion

What is Levodopa/Carbidopa/Entacapone Orion?

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

What is Levodopa/Carbidopa/Entacapone Orion used for?

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

How is Levodopa/Carbidopa/Entacapone Orion used?

Each Levodopa/Carbidopa/Entacapone Orion tablet contains one complete dose of levodopa, in seven strengths, with corresponding amounts of carbidopa and entacapone to improve its effectiveness. The strength of Levodopa/Carbidopa/Entacapone Orion that the patient should use is based on the amount of levodopa they need to control their symptoms. See the summary of product characteristics (also part of the EPAR) for full instructions on how patients should be switched toLevodopa/Carbidopa/Entacapone Orion, and on how the dose is adjusted during treatment.The maximum daily dose of Levodopa/Carbidopa/Entacapone Orion is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which it is seven tablets. Levodopa/Carbidopa/Entacapone Orion tablets should be taken whole, with or without food. They should be used with caution in patients with mild to moderately reduced liver function or severely reduced kidney function. They should not be used in patients with severe liver problems.

How does Levodopa/Carbidopa/Entacapone Orion work?

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

How has Levodopa/Carbidopa/Entacapone Orion been studied?

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

What benefit has Levodopa/Carbidopa/Entacapone Orion shown during the studies?

The studies showed that Levodopa/Carbidopa/Entacapone Orion is bioequivalent to the separate tablets.

What is the risk associated with Levodopa/Carbidopa/Entacapone Orion?

The most common side effects with Levodopa/Carbidopa/Entacapone Orion (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), muscle pain, diarrhoea and nausea (feeling sick) and harmless urine discoloration. Serious side effects which have been reported much less often include gastrointestinal haemorrhage (bleeding in the gut) and angioedema (swelling under the skin of face or limbs). For the full list of all side effects reported with Levodopa/Carbidopa/Entacapone Orion, see the package leaflet.Levodopa/Carbidopa/Entacapone Orion must not be used in people who are hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients. Levodopa/Carbidopa/Entacapone Orion must not be used in patients with:• severely reduced liver function;• narrow-angle glaucoma (increased pressure within the eye);• phaeochromocytoma (a tumour of the adrenal gland);• a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).Levodopa/Carbidopa/Entacapone Orion must not be used together with other medicines that belong to the group 'monoamine oxidase inhibitors' (a type of antidepressant). See the summary of product characteristics (also part of the EPAR) for full details.

Why has Levodopa/Carbidopa/Entacapone Orion been approved?

The CHMP decided that Levodopa/Carbidopa/Entacapone Orion's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Libmeldy

What is Libmeldy and what is it used for?

Libmeldy is a medicine used to treat children with metachromatic leukodystrophy (MLD). MLD is a rare inherited disorder in which there is a change (mutation) in a gene needed to make an enzyme called arylsulfatase A (ARSA), which breaks down substances called sulfatides. As a result, sulfatides build up and damage the nervous system and other organs, causing symptoms such as walking difficulties, gradual mental deterioration and eventual death.Libmeldy is used in children with MLD who have mutations in the ARSA gene. It is given to• those with late infantile or early juvenile forms of the disease who have not yet developed symptoms;• those with early juvenile MLD who have initial symptoms but can still walk independently and have not yet developed mental deterioration.Libmeldy is a type of advanced therapy medicine called a 'gene therapy'. This type of medicine works by delivering genes into the body. The active substance in Libmeldy is stem cells, (CD34+ cells), derived from the patient's own bone marrow or blood, that have been modified to contain a copy of the gene to make ARSA and can divide to produce other sorts of blood cells.MLD is rare, and Libmeldy was designated an 'orphan medicine' (a medicine used in rare diseases) on 13 April 2007. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu307446.

How is Libmeldy used?

Libmeldy can only be obtained with a prescription and treatment should only be given in a specialist transplant centre.To prepare Libmeldy, a sample containing stem cells is collected either from the patient's bone marrow or blood. These are modified to make Libmeldy by including a copy of the gene to make ARSA.Libmeldy can only be given to the patient whose cells were used to make the medicine. It is a single treatment, given as an infusion (drip) into a vein, and the dose depends on the patient's weight. A few days before treatment another medicine, busulfan, is given as a so-called conditioning treatment, to clear out existing bone marrow cells so they can be replaced with the modified cells in Libmeldy. Patients are also given other medicines before treatment to reduce the risk of reactions.For more information about using Libmeldy, see the package leaflet or contact your doctor or pharmacist.

How does Libmeldy work?

To make Libmeldy, the CD34+ cells (cells that can make white blood cells) are extracted from the blood or bone marrow. A gene allowing them to make ARSA is inserted into the CD34+ cells using a type of virus called a lentivirus, which has been altered genetically so that it can carry the ARSA gene into cells and does not cause viral disease in humans.Once given back into the patient's vein, Libmeldy is transported in the bloodstream to the bone marrow where the CD34+ cells start to grow and make normal white blood cells that can produce working ARSA. These white blood cells spread through the body and produce ARSA, helping to break down sulfatides in the surrounding cells, and so controlling symptoms of the disease. The effects are expected to be long-lasting.

What benefits of Libmeldy have been shown in studies?

The benefits of Libmeldy in treating MLD were shown in a main study involving 20 children with late infantile or early juvenile MLD. ARSA activity increased in all the children to levels above or within the range for healthy children within 3 months of treatment. After 2 years, the overall Gross Motor Function Measure score (a value between 0 and 100 measuring a developing child's ability to make normal movements such as crawling, standing and walking) was 72.5 in the group with late infantileMLD, compared to 7.4 in records of similar untreated children. Similarly, in children with early juvenile MLD, the average score 2 years after treatment with Libmeldy was 76.5, whereas that in previous untreated cases was 36.3. Benefit was greatest in children who had not yet developed symptoms and seemed to be lost in those who could no longer walk independently or had developed mental deterioration.There was evidence of continuing benefit on follow-up for up to 8 years.

What are the risks associated with Libmeldy?

The most common side effect with Libmeldy (which may affect more than 1 in 10 people) is development of antibodies to ARSA, although this does not seem to affect how well Libmeldy works. As a result of the conditioning treatment with busulfan, low white cell counts, sometimes with fever (a sign of infection), metabolic acidosis (imbalance in the body's acid levels), stomatitis (mouth inflammation), vomiting, hepatomegaly (enlarged liver), veno-occlusive liver disease (when blood vessels to the liver become blocked causing liver damage) and ovarian failure in girls are also very common.For the full list of side effects of Libmeldy, see the package leaflet.Libmeldy must not be used in patients who have had previous gene therapy involving blood stem cells, or in those who cannot be given the medicines needed to prepare them for producing or receiving Libmeldy. For the full list of restrictions, see the package leaflet.

Why is Libmeldy authorised in the EU?

The benefits of Libmeldy in patients with MLD who had not yet developed symptoms were clear, and during the study period patients maintained similar progress to healthy subjects. Benefit was less marked and more variable in those with early juvenile MLD who already have symptoms, so use in this group was restricted to those who can still walk and have not developed decline in mental function.Although benefit with Libmeldy lasted several years it is not yet clear whether it will persist life-long, and extended follow-up is needed. Because MLD is a rare disease, the studies are necessarily small and the amount of data available on side effects is limited, and will also need long-term follow-up; however, side effects seen to date were in line with those expected for this type of treatment. Given the seriousness of the condition and the lack of existing treatments, the European Medicines Agency decided that Libmeldy'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 Libmeldy?

The company that markets Libmeldy will carry out a long-term study to provide further information on the benefits and safety of the medicine, and will take steps to ensure that patients who qualify for the treatment can have the medicine produced quickly so they can be treated as early as possible, before symptoms start or progress. In addition, the company will provide educational materials for healthcare professionals and patients or their carers on how Libmeldy is to be used and monitored, and a patient alert card about their treatment for patients to show when receiving healthcare.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Libmeldy have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Libmeldy are continuously monitored. Side effects reported with Libmeldy are carefully evaluated and any necessary action taken to protect patients.

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Libmyris

What is Libmyris and what is it used for?

Libmyris is a medicine that acts on the immune system (the body's natural defences) and is used to treat the following conditions:• plaque psoriasis (a disease causing red, scaly patches on the skin);• psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);• rheumatoid arthritis (a disease causing inflammation of the joints);• polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis (both rare diseases causing inflammation in the joints);• axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there are clear signs of inflammation but X-ray does not show disease;• Crohn's disease (a disease causing inflammation of the gut);• ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);• hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;• non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).Libmyris is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments. For more information on the use of Libmyris in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.Libmyris is a 'biosimilar medicine'. This means that Libmyris is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Libmyris is Humira. For more information on biosimilar medicines, see here.Libmyris contains the active substance adalimumab.

How is Libmyris used?

Libmyris is available for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks. The dose and frequency of injection depend on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Libmyris is only available in doses of 40 or 80 mg, it is not suitable for children who need less than a 40-mg dose. After training, patients or their carers may inject Libmyris if their doctor considers it appropriate.Libmyris can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Libmyris is used. Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.For more information about using Libmyris, see the package leaflet or contact your doctor or pharmacist.

How does Libmyris work?

The active substance in Libymrys, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Libmyris is used to treat. By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.

What benefits of Libmyris have been shown in studies?

Laboratory studies comparing Libmyris with Humira have shown that the active substance in Libmyris is highly similar to that in Humira in terms of structure, purity and biological activity. Studies have also shown that giving Libmyris produces similar levels of the active substance in the body to giving Humira.In addition, a study involving 412 adult patients with plaque psoriasis has shown that Libmyris was as effective as Humira in controlling the disease; average scores measuring the extent and severity of the condition improved by 91% after 16 weeks of treatment with either medicine.Because Libmyris is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Libmyris.

What are the risks associated with Libmyris?

The safety of Libmyris 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 Humira.The most common side effects with adalimumab (which may affect more than 1 in 10 people) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain. Like other medicines of its class, Libmyris may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.Other rare serious side effects of adalimumab (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).Libmyris must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).For the full list of side effects and restrictions with Libmyris, see the package leaflet.

Why is Libmyris authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Libmyris has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way. In addition, studies in adults with plaque psoriasis have shown that the safety and effectiveness of Libmyris is equivalent to that of Humira in this group.All these data were considered sufficient to conclude that Libmyris will behave in the same way as Humira in terms of effectiveness and safety in its authorised uses. Therefore, the Agency's view was that, as for Humira, the benefits of Libmyris 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 Libmyris?

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

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Libtayo

What is Libtayo and what is it used for?

Libtayo is a cancer medicine used in adults to treat:• a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It is used in patients who cannot have surgery or treatment with radiation to cure their disease;• a type of skin cancer called basal cell carcinoma (BCC) when the cancer is locally advanced or metastatic. It is used in patients who cannot tolerate treatment with a type of medicine called a'hedgehog pathway inhibitor (HHI)' or whose disease has worsened after such treatment;• a type of lung cancer called non-small cell lung cancer (NSCLC) when the cancer is locally advanced and cannot be treated with chemotherapy (medicines to treat cancer) and radiation therapy, or when the cancer is metastatic. It is used either alone in patients whose tumours have a protein called PD-L1 in more than 50% of cells and no mutations in the genes EGFR, ALK and ROS1 involved in the development of NSCLC, or together with platinum-based chemotherapy in patients whose tumours have PD-L1 in at least 1% of the cells and no mutations in the EGFR, ALK and ROS1 genes.• cervical cancer that has come back (recurrent) or is metastatic. It is used in patients whose disease has progressed during or after treatment with platinum-based chemotherapy.Libtayo contains the active substance cemiplimab.

How is Libtayo used?

Treatment with Libtayo must be started and supervised by a doctor experienced in treating cancer. The medicine can only be obtained with a prescription.Libtayo is given as an infusion (drip) into a vein once every 3 weeks. Treatment can continue for as long as the disease remains stable and the patient does not experience unacceptable side effects.For more information about using Libtayo, see the package leaflet or contact your doctor or pharmacist.

How does Libtayo work?

The active substance in Libtayo, cemiplimab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells. Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.

What benefits of Libtayo have been shown in studies?

Cutaneous squamous cell carcinomaLibtayo is effective at treating cutaneous squamous cell carcinoma in patients. In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received Libtayo every 3 weeks for around one year. Among patients with locally advanced disease who received Libtayo every 2 weeks for around 2 years, 44% of patients showed shrinkage of their cancer.Basal cell carcinomaTreatment with Libtayo showed benefits in patients with locally advanced and metastatic BCC. In a study involving patients who were given Libtayo for around one year, the cancer shrank in 32% (27 out of 84) of patients with locally advanced disease and 29% (10 out of 35) of patients with metastatic disease. Libtayo was not compared with another treatment in this study.Non-small cell lung cancerIn a study involving 710 patients with advanced or metastatic EGFR/ALK/ROS1-negative NSCLC with high levels of PD-L1 (in more than 50% of tumour cells), patients treated with Libtayo lived longer (about 22 months on average) than those treated with platinum-based chemotherapy (about 14 months). Patients treated with Libtayo lived without their disease getting worse for 6.2 months on average, compared with 5.6 months for patients given chemotherapy.A second study involving 466 patients with advanced or metastatic EGFR/ALK/ROS1-negative NSCLC found that in patients whose tumours produce PD-L1 in at least 1% of cells, Libtayo given with platinum-based chemotherapy increased the time that patients lived. Of the 327 patients with PD-L1 in at least 1% of tumour cells, those treated with Libtayo plus platinum-based chemotherapy lived for an average of 22 months compared with 13 months for those treated with platinum-based chemotherapy alone. In addition, patients treated with Libtayo plus chemotherapy lived for about 9 months without their disease getting worse, compared with 6 months for patients given chemotherapy alone.Cervical cancerIn a main study in 608 patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy, patients given Libtayo lived for about 12 months, compared with 8.5 months for those given chemotherapy. On average, patients treated with Libtayo lived without their disease getting worse for 2.8 months, compared with 2.9 months for patients given chemotherapy.

What are the risks associated with Libtayo?

For the full list of side effects and restrictions with Libtayo, see the package leaflet.Libtayo is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping the medicine.When Libtayo is used alone, the most common immune-related effects (which may affect up to 1 in 10 people) include hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), hyperthyroidism (an overactive thyroid gland which can cause weight loss, nervousness, rapid heartbeat and tiredness), pneumonitis (inflammation in the lungs causing shortness of breath and cough), hepatitis (inflammation of the liver), colitis (inflammation of the large bowel) and skin reactions.When Libtayo is used with platinum-based chemotherapy, the most common immune-related effects (which may affect up to 1 in 10 people) include hypothyroidism, hyperthyroidism, increased or decreased levels of thyroid-stimulating hormone in the blood (which could be signs of an underactive or overactive thyroid gland), skin reactions and pneumonitis.Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (lifethreatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with Libtayo.

Why is Libtayo authorised in the EU?

Libtayo is effective at treating cutaneous squamous cell carcinoma, a cancer with few treatment options once it has spread, and basal cell carcinoma, for which no other options were available for second-line treatment (treatment given when first treatment is not sufficiently effective or stops working) at the time of authorisation. Libtayo also showed promising effectiveness in the treatment of NSCLC with high PD-L1 levels and in the treatment of cervical cancer after progression during or after treatment with platinum-based chemotherapy. Libtayo used in combination with platinum-based chemotherapy is also effective at treating NSCLC where at least 1% of tumour cells produce PD-L1.As for the medicine's safety, Libtayo's side effects are considered manageable and similar to those seen with other monoclonal antibody cancer treatments.The European Medicines Agency therefore decided that Libtayo's benefits are greater than its risks and it can be authorised for use in the EU.Libtayo was originally given 'conditional authorisation' 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 authorisation.

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

The company that markets Libtayo will provide a guide and an alert card for patients with information on the signs and symptoms of immune-related side effects of the medicine, as well as instructions on contacting their doctor if they experience symptoms.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Libtayo have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Libtayo are continuously monitored. Side effects reported with Libtayo are carefully evaluated and any necessary action taken to protect patients.

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Liprolog

What is Liprolog and what is it used for?

Liprolog is a range of insulin medicines used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.Liprolog medicines contain the active substance insulin lispro on its own or combined with protamine to make it longer acting:• Liprolog (100 units/ml): standard-strength insulin lispro (fast-acting);• Liprolog (200 units/ml): high-strength insulin lispro (fast-acting);• Liprolog Mix25 (100 units/ml): 25% insulin lispro (fast-acting) and 75% insulin lispro protamine (longer-acting);• Liprolog Mix50 (100 units/ml): 50% insulin lispro (fast-acting) and 50% insulin lispro protamine (longer-acting).

How is Liprolog used?

Liprolog medicines are available as solutions or suspensions for injection in vials, cartridges or prefilled pens.The medicines are given by injection under the skin of the upper arm, thigh, buttock or abdomen (belly). Liprolog 100 units/ml may also be given by continuous infusion under the skin using an insulin pump or by injection into a vein. Liprolog 200 units/ml, Liprolog Mix25 and Liprolog Mix50 should never be given into a vein.The dose depends on the individual patient's needs and may be reduced in patients with reduced kidney or liver function. The medicines are normally given shortly before a meal, but can be given just after a meal if necessary.Liprolog (100 or 200 units/ml) can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).Patients can inject themselves with this medicine if they have been trained appropriately.Liprolog can only be obtained with a prescription. For more information about using Liprolog, see the package leaflet or contact your doctor or pharmacist.

How does Liprolog work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. Liprolog is a replacement insulin which is very similar to the insulin made by the body.The active substance in Liprolog, insulin lispro, 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 insulin lispro.Insulin lispro has a small difference from human insulin that allows it to be absorbed faster by the body so it can act shortly after injection. Liprolog Mix25 and Liprolog Mix50 contain both insulin lispro and a longer-acting form called insulin lispro protamine, which is absorbed more slowly so that it works for longer.Liprolog works in the same way as naturally produced insulin and helps glucose from the blood to enter cells. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

What benefits of Liprolog have been shown in studies?

Liprolog was originally studied in eight clinical trials including 2,951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively). The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day.The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and 'fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours). Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.Studies also looked at the use of Liprolog in 542 patients aged between two and 19 years. The medicine's effects in the body were similar in both adults and children.Studies on the use of Liprolog in combination with sulphonylureas showed that these medicines used together reduce HbA1c more than sulphonylureas used alone.

What are the risks associated with Liprolog?

Liprolog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low.For the full list of side effects and restrictions with Liprolog, see the package leaflet.

Why is Liprolog authorised in the EU?

Liprolog has been shown to effectively reduce glucose levels and is comparable to human insulin. The European Medicines Agency decided that Liprolog'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 Liprolog?

When first marketing the high-strength Liprolog (200 units/ml), the company provided information for patients and healthcare professionals to advise them of the 2 strengths and on how to use them safely to avoid medication errors.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Liprolog have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Liprolog are continuously monitored. Side effects reported with Liprolog are carefully evaluated and any necessary action taken to protect patients.

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Litak

What is Litak?

Litak is a solution for injection that contains the active substance cladribine.

What is Litak used for?

Litak is used to treat adults with hairy cell leukaemia, a cancer of blood in which too manyB-lymphocytes (a type of white blood cell) are produced. The term 'hairy cell' refers to the hair-like projections that can be seen on the surface of the lymphocytes when they are examined under a microscope.Because the number of patients with hairy cell leukaemia is low, the disease is considered 'rare', and Litak was designated an 'orphan medicine' (a medicine used in rare diseases) on 18 September 2001. The medicine can only be obtained with a prescription.

How is Litak used?

Litak treatment should be started by a doctor who has experience in the use of cancer treatments. Litak is given as an injection under the skin. The recommended dose is 0.14 mg per kilogram body weight, once a day for five days. Patients can inject themselves once they have been trained appropriately. Litak must not be given to patients with moderate to severe liver or kidney disease. It should be used with caution in patients over 65 years of age, with frequent monitoring of blood counts, the liver and the kidneys.

How does Litak work?

The active substance in Litak, cladribine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells. It belongs to the group of anticancer medicines called 'antimetabolites'. Cladribine is an 'analogue' of purine (a substance that has a similar chemical structure to purine). Purine is one of the fundamental chemicals that make up DNA. In the body, cladribine is converted within lymphocytes into a chemical called CdATP, which interferes with the production of new DNA. This prevents the cells from dividing, slowing down the progression of leukaemia. CdATP can also affect other cells, particularly other types of blood cell, which can cause side effects.Cladribine has been in use in anticancer medicines since the 1980s and it has been available as an intravenous infusion (drip into a vein) in some European Union (EU) Member States since 1993.

How has Litak been studied?

Because cladribine has been used for a number of years, the company presented data from the published literature. Litak has been examined in one main study involving 63 adults with hairy cell leukaemia. Litak was not compared with any other treatments in this study. The main measures of effectiveness were the numbers of patients who had complete and partial remission following treatment. Complete remission is the disappearance of all evidence of disease, whereas partial remission is improved blood counts and the reduction in the number of cancerous cells.

What benefit has Litak shown during the studies?

In the main study, 97% of the patients had either complete or partial remission (60 out of 62), and 76% had complete remission (47 out of 62). These results were similar to those seen in other published studies using intravenous cladribine and were better than results seen with alternative treatments such as interferon alfa and pentostatin.

What is the risk associated with Litak?

The most common side effects with Litak (seen in more than 1 patient in 10) are infections, pancytopenia or myelosuppression (low blood cell counts), purpura (bruising), immunosuppression (a weakened immune system), decreased appetite, headache, dizziness, abnormal breath and chest sounds, cough, nausea (feeling sick), vomiting, constipation, diarrhoea, rash, localised exanthema (skin eruptions), diaphoresis (excessive sweating), injection site reactions (pain and inflammation at the site of injection), fever, fatigue (tiredness), chills and asthenia (weakness). For the full list of all side effects reported with Litak, see the Package Leaflet.Litak should not be used in people who may be hypersensitive (allergic) to cladribine or any of the other ingredients. Litak must not be used during pregnancy or breast-feeding, in patients less than 18 years of age, in patients with moderate to severe kidney or liver disease or in combination with other medicines that reduce the production of blood cells.

Why has Litak been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Litak's benefits are greater than its risks for the treatment of hairy cell leukaemia. The Committee recommended that Litak be given marketing authorisation.

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Litfulo

What is Litfulo and what is it used for?

Litfulo is a medicine used to treat adults and adolescents over 12 years of age with severe alopecia areata, an autoimmune disease (a disease caused by the body's own defence system attacking normal tissue) causing hair loss of the scalp or other parts of the body.Litfulo contains the active substance ritlecitinib.

How is Litfulo used?

Litfulo can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the diagnosis and treatment of alopecia areata.Litfulo is available as capsules taken by mouth once a day. Treatment should be interrupted or stopped if patients experience serious infections or low blood cell levels. Treatment should be stopped if no improvements are seen after 36 weeks.For more information about using Litfulo, see the package leaflet or contact your doctor or pharmacist.

How does Litfulo work?

In people with alopecia areata, the immune system attacks the hair follicles and causes hair growth to slow or stop altogether, leading to hair loss. The active substance in Litfulo, ritlecitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system). It works by blocking the action of certain enzymes called JAK3 and TEC kinases, which play an important role in inflammation. By blocking these enzymes, ritlecitinib reduces inflammation, allowing hair regrowth in people with alopecia areata.

What benefits of Litfulo have been shown in studies?

The benefits of Litfulo were investigated in a main study involving 718 adults and adolescents over 12 years of age with severe alopecia areata, 261 of whom were given 50 mg Litfulo or placebo (a dummy treatment). All patients had more than 50% hair loss on the scalp before they started treatment. After 24 weeks of treatment, disease symptoms improved in patients given Litfulo: 13% of them were in near remission, meaning that they had more than 90% hair coverage on their scalp, and 23% hadmore than 80% hair coverage. Such improvements were seen in 1.5% of patients given placebo. After 48 weeks, 31% of patients given Litfulo were in near remission. When asked whether their alopecia had improved, 49% of patients given Litfulo stated that their condition had moderately or greatly improved, compared with 9% of patients given placebo.

What are the risks associated with Litfulo?

For the full list of side effects and restrictions with Litfulo, see the package leaflet.The most common side effects with Litfulo (which may affect up to 1 in 10 people) include diarrhoea, acne, upper respiratory tract (nose and throat) infections, urticaria (itchy rash), rash, folliculitis (inflammation of hair follicles) and dizziness.Litfulo must not be used in patients with active serious infections, including tuberculosis, or severe liver problems. The medicine also must not be used in women who are pregnant or breast-feeding.

Why is Litfulo authorised in the EU?

Litfulo was shown to be effective in the treatment of severe alopecia areata in adults and adolescents, and the benefits were maintained over time. Although the side effects of Litfulo are considered manageable, there are uncertainties regarding long-term use due to limited data. Several measures have been put in place to minimise risks associated with Litfulo.Given the importance of scalp hair regrowth for patients with severe alopecia areata, the European Medicines Agency decided that Litfulo'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 Litfulo?

The company that markets Litfulo must provide educational materials to healthcare professionals and patients with information on the safety of the medicine, specifically regarding the risk of infections, cardiovascular conditions (diseases affecting the heart or blood vessels), cancer, neurotoxicity (damage to the nervous system) and toxicity to the unborn baby when exposed during pregnancy.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Litfulo have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Litfulo are continuously monitored. Suspected side effects reported with Litfulo are carefully evaluated and any necessary action taken to protect patients.

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Livmarli

What is Livmarli and what is it used for?

Livmarli is a medicine used for treating patients aged 2 months and older with cholestatic pruritis (intense itching due to a build-up of bile) caused by Alagille syndrome.Alagille syndrome is an inherited disease in which bile (a fluid produced in the liver that helps to break down fats) cannot drain properly from the liver, resulting in a build-up of bile acid in the liver and blood. One of the symptoms of this build-up is cholestatic pruritis.Alagille syndrome is rare, and Livmarli was designated an 'orphan medicine' (a medicine used in rare diseases) on 18 December 2013. Further information on the orphan designation can be found here: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1214.Livmarli contains the active substance maralixibat chloride.

How is Livmarli used?

Treatment with Livmarli must be started and supervised by a doctor experienced in treating liver diseases such as Alagille syndrome. The medicine can only be obtained with a prescription.Livmarli is available as a solution to be taken by mouth. The dose depends on the patient's body weight and is given once a day. Treatment is started with a low dose which the doctor will increase after one week. In case the patient develops certain side effects the dose may have to be reduced or treatment interrupted. For patients who do not show an improvement after 3 months the doctor should consider an alternative treatment.For more information about using Livmarli, see the package leaflet or contact your doctor or pharmacist.

How does Livmarli work?

The active substance in Livmarli, maralixibat chloride, blocks the action of a protein called apical sodium-dependent bile acid transporter (ASBT), also known as ileal bile acid transporter (IBAT), that helps to transport bile acids from the gut back to the blood and liver. By blocking ASBT, the medicine reduces the amount of bile acid that is transported from the gut into the liver. This leads to excess bileacid being removed from the body, thereby reducing the build-up of bile acid and relieving the symptoms of cholestatic pruritis.

What benefits of Livmarli have been shown in studies?

The benefits of Livmarli were evaluated in two main studies. In the first study, 31 children aged from 1 to 18 years with Alagille syndrome were treated with Livmarli for 18 weeks, after which their response to treatment was evaluated.The 29 patients who had a decrease in the levels of bile acids in their blood of at least 50% following the initial 18-week treatment with the medicine were subsequently assigned to receive either placebo (dummy treatment) or Livmarli for 4 weeks. Results showed that patients who continued treatment with Livmarli for 4 weeks still had a reduction in the level of bile acid while those who switched treatment to placebo had significant increases. After this 4-week period, all patients received Livmarli again. When the patients who took placebo resumed treatment with Livmarli, their blood levels reduced to levels previously observed with Livmarli. The study also showed that treatment with Livmarli improved symptoms of itching associated with the disease.In the second study, involving 8 children aged from 2 months to less than 1 year, Livmarli was not compared with any other treatment or placebo. Results of the study showed that after 13 weeks of treatment, patients had, on average, an improvement in symptoms of itching associated with the disease and a reduction in the level of bile acids in their blood.

What are the risks associated with Livmarli?

The most common side effects with Livmarli (which may affect more than 1 in 10 people) are diarrhoea and abdominal pain (belly ache).For the full list of side effects and restrictions of Livmarli, see the package leaflet.

Why is Livmarli authorised in the EU?

Alagille is a life-threatening disease; at the time of authorisation of Livmarli, there was no other approved treatment for this disease. As it is a very rare disease, the studies were small and subject to limitations, but Livmarli was shown to be effective at reducing the amount of bile acid in the blood of patients with the disease and improving symptoms related to this, such as intense itching. Although the data on the safety of Livmarli are limited and further data needs to be gathered, the side effects seen to date are considered acceptable. The European Medicines Agency therefore decided that Livmarli's benefits are greater than its risks and it can be authorised for use in the EU.Livmarli has been authorised under 'exceptional circumstances'. This is because it has not been possible to obtain complete information about Livmarli due to the rarity of the disease. Every year, the European Medicines Agency will review any new information that becomes available, and this overview will be updated as necessary.

What information is still awaited for Livmarli?

Since Livmarli has been authorised under exceptional circumstances, the company that marketsLivmarli will provide yearly updates on any new information concerning the safety and efficacy of Livmarli. In addition, the company will conduct and submit the results of a study to further characterise the long-term safety and efficacy of the medicine for the treatment of cholestatic pruritis.

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

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

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Livogiva

What is Livogiva and what is it used for?

Livogiva is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in:• women who have been through the menopause;• 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).Livogiva is a 'biosimilar medicine'. This means that Livogiva is highly similar to another biological medicine (the 'reference medicine') that is already authorised in the EU. The reference medicine for Livogiva is Forsteo. For more information on biosimilar medicines, see here.Livogiva contains the active substance teriparatide.

How is Livogiva used?

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

How does Livogiva work?

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

What benefits of Livogiva have been shown in studies?

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

What are the risks associated with Livogiva?

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

Why is Livogiva authorised in the EU?

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

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

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Livtencity

What is Livtencity and what is it used for?

Livtencity is an antiviral medicine used to treat illness caused by cytomegalovirus (CMV) in adults who have had a haematopoietic stem cell transplant or an organ transplant. It is used in patients whose CMV illness has not responded to at least one other treatment, including ganciclovir, valganciclovir, cidofovir or foscarnet.Haematopoietic stem cell transplantation involves using stem cells from a donor to replace the recipient's bone marrow cells. The donated stem cells will form new bone marrow that produces healthy blood cells.CMV is a common virus that usually only causes mild infection in healthy people. After infection, the virus remains in the body in an inactive form and does not cause harm. However, CMV can become active and cause illness in patients whose immune system (the body's natural defences) is weakened, such as those who have had a stem cell or organ transplant.CMV disease is rare, and Livtencity was designated an 'orphan medicine' (a medicine used in rare diseases) on 18 December 2007 and 7 June 2013. Further information on the orphan designations can be found here: ema.europa.eu/medicines/human/orphan-designations/eu307519 and ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1133.Livtencity contains the active substance maribavir.

How is Livtencity used?

Livtencity can only be obtained with a prescription and should be used according to official recommendations. Treatment should be started by a doctor experienced in managing patients who have had a haematopoietic stem cell or organ transplant.Livtencity is available as tablets to be taken by mouth and the recommended dose is 400 mg twice a day for 8 weeks. Treatment duration may be adjusted depending on the patient's condition and response to treatment.For more information about using Livtencity, see the package leaflet or contact your doctor or pharmacist.

How does Livtencity work?

Maribavir, the active substance in Livtencity, blocks an enzyme (a type of protein) from CMV called UL97 protein kinase, which the virus needs to multiply. This stops the virus from multiplying and infecting other cells.

What benefits of Livtencity have been shown in studies?

Livtencity was found to be more effective than other available CMV treatment at clearing CMV infection in adults who had undergone a stem cell or organ transplant and whose CMV infection had not responded to prior treatment. In a main study involving 352 adults, 56% (131 out of 235) of patients treated with Livtencity had undetectable levels of CMV after 8 weeks compared with 24% (28 out of 117) of those who received another CMV treatment chosen by their doctor.

What are the risks associated with Livtencity?

The most common side effects with Livtencity (which may affect more than 1 in 10 people) are taste disturbance, nausea (feeling sick), diarrhoea, vomiting and tiredness.Serious side effects (which may affect more than 1 in 100 people) include diarrhoea, nausea, vomiting, weight loss, tiredness, and increased blood levels of immunosuppressant medicine (a medicine used to reduce activity of the immune system).For the full list of side effects of Livtencity, see the package leaflet.Livtencity must not be used together with ganciclovir or valganciclovir (other antiviral medicines).For the full list of restrictions of Livtencity, see the package leaflet.

Why is Livtencity authorised in the EU?

Livtencity was effective at clearing CMV from the blood, and its safety profile is acceptable and more favourable than available treatments. The European Medicines Agency therefore decided that Livtencity'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 Livtencity?

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

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Lixiana

What is Lixiana and what is it used for?

Lixiana is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:• to prevent stroke (caused by blood clots in the brain) and systemic embolism (blood clots in other organs) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). It is used in patients who have one or more risk factors, such as high blood pressure, diabetes, heart failure, having had a stroke or being 75 years old or over;• to treat deep-vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occurring.Lixiana contains the active substance edoxaban.

How is Lixiana used?

Lixiana is available as tablets and can only be obtained with a prescription. The usual dose is 60 mg once a day but doses may be adjusted for kidney function, low body weight or in those who are also taking certain medicines (known as P-gp inhibitors) that can interfere with the removal of edoxaban from the body. Dose adjustments may also need to be made in patients who are switched between Lixiana and other anticoagulant medicines. Treatment is continued while the benefit outweighs the risk of bleeding, which depends on the condition being treated and any existing risk factors. For more information about using Lixiana, see the package leaflet or contact your doctor or pharmacist.

How does Lixiana work?

The active substance in Lixiana, edoxaban, is a 'factor Xa inhibitor'. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is essential for blood clotting. By blocking factor Xa, the medicine reduces the levels of thrombin in the blood, which helps treat clots and reduce the risk of them forming in the arteries and veins and leading to DVT, pulmonary embolism, stroke or other organ damage.

What benefits of Lixiana have been shown in studies?

Lixiana has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation. The effects were studied in one main study, which involved over 21,000 patients for an average of 2.5 years. The main measure of effectiveness was the rate of stroke or systemic embolism among the patients each year. A first systemic embolism or stroke occurred in around 1.2% of those given standard doses of Lixiana and 1.5% of those given warfarin respectively. When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 0.9% of patients given Lixiana and 1% of those given warfarin. There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Lixiana was also found to be as effective as warfarin, in a study involving over 8,200 patients. The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period. Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%).

What are the risks associated with Lixiana?

The most common side effects with Lixiana (which may affect up to 1 in 10 people) are nose bleeds (epistaxis), blood in the urine (haematuria) and anaemia (low levels of red blood cells). Bleeding can occur at any site and can be severe or even fatal. For the full list of side effects of Lixiana, see the package leaflet.Lixiana must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding. It must also not be used in pregnant or breastfeeding women or in patients also being treated with another anticoagulant. For the full list of restrictions, see the package leaflet.

Why is Lixiana authorised in the EU?

The European Medicines Agency decided that Lixiana's benefits are greater than its risks and it can be authorised for use in the EU. The medicine has been shown to be at least as effective as warfarin in reducing stroke rates in patients with atrial fibrillation and in preventing further episodes of DVT or pulmonary embolism.With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed. Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Agency considered that the risk could be managed with appropriate measures.

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

The company that markets Lixiana will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lixiana have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lixiana are continuously monitored. Side effects reported with Lixiana are carefully evaluated and any necessary action taken to protect patients.

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Locametz

What is Locametz and what is it used for?

Locametz is a diagnostic medicine used in adults with prostate cancer to detect prostate cancer cells with a protein called prostate-specific membrane antigen (PSMA) using the body scan known as positron-emission tomography (PET).It is used:• to find out whether prostate cancer has spread to lymph nodes and other tissues outside the prostate before curative treatment is started;• to find out whether prostate cancer has returned in patients whose blood levels of prostate specific antigen (PSA) are increasing after previous curative treatment;• to find out whether patients have PSMA-positive progressive metastatic castration-resistant prostate cancer, which may be suitable for a specific therapy called PSMA-targeted therapy. Metastatic castration-resistant prostate cancer is cancer that has spread to other parts of the body despite treatment to lower testosterone levels, including surgical removal of the testes.Before use, the medicine is coupled (radiolabelled) with a radioactive substance called gallium (68Ga) so that it can carry radioactivity to the site of the cancer cells and allow detection of these cells using PET.Locametz contains the active substance gozetotide.

How is Locametz used?

The medicine can only be given in a designated nuclear medicine facility by trained healthcare professionals with technical expertise in using and handling nuclear medicine imaging agents.Locametz is never given to a patient on its own. Before it is given it must be radiolabelled with gallium (68Ga). The radiolabelled Locametz is then given as a slow injection into a vein at a dose depending on the patient's weight, and a PET scan is done after the injection.For more information about using Locametz, see the package leaflet or contact your doctor or pharmacist.

How does Locametz work?

The active substance of Locametz, gozetotide, binds to PSMA, which is found in large numbers on the surface of most prostate cancer cells. When Locametz is radiolabelled with gallium (68Ga) and given to a patient, it binds to PSMA and is taken up by the cells and gives off radiation, which can be detected with a PET scan. This allows the doctors to see where in the body the cancer cells are.

What benefits of Locametz have been shown in studies?

Several published studies have supported the usefulness of gozetotide that has been radiolabelled with gallium (68Ga) as a sensitive and accurate diagnostic medicine to detect if prostate cancer has returned or spread or if cancer cells contain PSMA.

What are the risks associated with Locametz?

The most common side effects with gallium (68Ga)-radiolabelled Locametz are tiredness (which may affect up to 1 in 10 people), nausea (feeling sick), constipation and vomiting (which may affect up to 1 in 100 people).For the full list of side effects and restrictions with Locametz, see the package leaflet.

Why is Locametz authorised in the EU?

The European Medicines Agency considered that the use of gallium (68Ga)-radiolabelled Locametz was well documented in the scientific literature, with data suggesting that gallium (68Ga)-radiolabelled Locametz may offer improvements over existing methods for detecting prostate cancer that has not yet been treated or has returned, or for screening patients who may benefit from PSMA-targeted treatment. Locametz's side effects were usually mild and its safety profile was considered acceptable. The Agency therefore decided that Locametz'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 Locametz?

The company that markets Locametz will provide medical practitioners who are expected to use gallium (68Ga)-radiolabelled Locametz with educational materials to support interpretation of PET scans.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Locametz have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Locametz are continuously monitored. Suspected side effects reported with Locametz are carefully evaluated and any necessary action taken to protect patients.

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Lojuxta

What is Lojuxta and what is it used for?

Lojuxta is a medicine that contains the active substance lomitapide. It is used to treat adult patients with homozygous familial hypercholesterolaemia, an inherited disease causing high blood levels of cholesterol (a type of fat). It is used together with a low fat diet and other medicines to reduce the level of fats in the blood. The patient's disease should be confirmed by genetic testing whenever possible.

How is Lojuxta used?

Lojuxta can only be obtained with a prescription. It is available as capsules (5, 10, 20, 30, 40 and 60 mg) to be taken by mouth on an empty stomach, at least two hours after the evening meal. Treatment should be started and monitored by a doctor experienced in treating conditions involving high levels of fats in the blood. Treatment should begin at a dose of 5 mg once per day, and if well tolerated may be steadily increased to a maximum dose of 60 mg per day. Patients with moderately or severely reduced liver function must not take Lojuxta. Patients on kidney dialysis may need to take a reduced dose. Patients taking certain other medicines may also need to take a reduced dose or take Lojuxta and their other medication at different times. Patients should avoid drinking grapefruit juice while taking Lojuxta. For further information, see the package leaflet.

How does Lojuxta work?

The active substance in Lojuxta, lomitapide, blocks the action of a substance in the body called 'microsomal triglyceride transfer protein', which is present in the cells of the liver and the gut. Microsomal triglyceride transfer protein is involved in assembling fatty substances such as cholesterol and triglyceride into larger particles called lipoproteins, which are then released into the blood stream. By blocking this protein, Lojuxta decreases the level of fats released into the blood, thereby helping to reduce the level of cholesterol in hypercholesterolaemia.

What benefits of Lojuxta have been shown in studies?

The benefits of Lojuxta in reducing blood cholesterol were assessed in a main study involving 29 patients with homozygous familial hypercholesterolaemia. All patients were given Lojuxta together with other medicines for reducing the level of fats in the blood. Lojuxta was not compared with any other treatment. The main measure of effectiveness was the change in the patients' blood levels of 'low density lipoprotein' (LDL) cholesterol, commonly known as 'bad cholesterol', after 26 weeks of treatment. On average, the patients' LDL cholesterol levels were reduced by 40%.

What are the risks associated with Lojuxta?

The most serious side effect seen in some patients treated with Lojuxta is abnormally raised liver enzyme levels. The most common side effects are problems with the gut, which may affect as many as 9 out of 10 people: diarrhoea and nausea (feeling sick) were each seen in around 7 out of 10 people, dyspepsia (heartburn) and vomiting were each seen in more than 3 out of 10 people, while pain, discomfort and bloating of the abdomen (belly), constipation and flatulence were each seen in at least 2 out of 10 people. For the full list of side effects, see the package leaflet.Lojuxta must not be used in women who are pregnant. It must also not be used by patients with moderately or severely reduced liver function or with unexplained, abnormal liver test results, or by patients with significant or long-term bowel problems. Lojuxta must not be used together with over 40 mg per day of simvastatin (another medicine used to lower blood cholesterol levels) or with certain other medicines that affect the way lomitapide is broken down in the body. For the full list of restrictions, see the package leaflet.

Why is Lojuxta approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lojuxta's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the medicine's effect in reducing LDL cholesterol levels was a benefit for patients with homozygous familial hypercholesterolaemia, who have an unmet medical need. However, the CHMP noted that the long-term benefit for the heart and circulatory system still needed to be confirmed. The Committee also noted that Lojuxta had side effects in the gut in most patients, which caused some patients to stop treatment, and that it led to increased liver enzyme levels whose long-term consequences are not known. Therefore, the Committee considered that these effects need to be closely monitored and managed.Lojuxta has been authorised under 'exceptional circumstances'. This is because it has not been possible to obtain complete information about Lojuxta to date due to the rarity of the disease. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.Lojuxta

What information is still awaited for Lojuxta?

Since Lojuxta has been approved under exceptional circumstances, the company that markets the medicine is carrying out a long-term study in patients taking Lojuxta to provide further data on its safety and effectiveness, including its side effects on the liver, stomach, gut, and cardiovascular system. The study will also provide data on pregnancies in women taking the medicine, and on healthcare professionals' compliance with the recommendations to screen and monitor patients before and during treatment.

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

A risk management plan has been developed to ensure that Lojuxta 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 Lojuxta, including the appropriate precautions to be followed by healthcare professionals and patients.In addition, the company that markets Lojuxta will provide educational materials to all doctors expected to prescribe Lojuxta, containing information on how to select suitable patients as well as key safety information, including side effects, interactions with other medicines and use in women who could potentially have children. It will also contain educational materials to be given to patients, including a brochure and an alert card.

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Lokelma

What is Lokelma and what is it used for?

Lokelma is a medicine used to treat hyperkalaemia (high levels of potassium in the blood) in adults. It contains the active substance sodium zirconium cyclosilicate.

How is Lokelma used?

Lokelma is available as powder sachets (5 g and 10 g). The powder is stirred into water to make a mixture to be drunk straight away. The recommended starting dose of Lokelma is 10 g three times a day. Once the blood levels of potassium return within the normal range (usually within 1-2 days), patients should take the lowest effective dose of Lokelma to prevent the return of hyperkalaemia, starting with 5 g once a day and not exceeding 10 g once a day. For further information, see the package leaflet.The medicine can only be obtained with a prescription.

How does Lokelma work?

The active substance in Lokelma, sodium zirconium cyclosilicate, is a potassium binder. When taken by mouth, Lokelma attaches to potassium from food and body fluids in the gut, forming a compound thatis then eliminated in the stools. This action removes potassium from the body overall, thus helping to lower the potassium levels in the blood.

What benefits of Lokelma have been shown in studies?

Lokelma is effective at lowering blood potassium levels and keeping levels of potassium within the normal range.In a main study of 754 patients with hyperkalaemia, 86% of patients taking Lokelma 10 g had normal potassium levels after 2 days compared with 48% of those taking placebo (a dummy treatment). In addition, when patients who had normal potassium levels after Lokelma treatment were given further treatment with either Lokelma or placebo, potassium levels stayed normal for longer with Lokelma than with placebo.Another main study involved 258 patients who had normal potassium levels after Lokelma treatment. In this 4-week study, patients receiving further treatment with Lokelma had lower potassium levels from the second week of treatment than patients taking placebo.

What are the risks associated with Lokelma?

The most common side effects with Lokelma (which may affect up to 1 in 10 people) are oedema (fluid build-up with swelling in the ankles and feet) and hypokalaemia (low levels of potassium in the blood).For the full list of all side effects and restrictions with Lokelma, see the package leaflet.

Why is Lokelma approved?

The European Medicines Agency decided that Lokelma's benefits are greater than its risks and recommended that it be approved for use in the EU. The Agency considered that Lokelma is effective at controlling blood potassium levels, especially during initial (acute) treatment. The overall safety profile is considered acceptable.

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

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

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Lonquex

What is Lonquex and what is it used for?

Lonquex is a medicine that contains the active substance lipegfilgrastim. It is used 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 with cancer aged 2 years and older receiving cytotoxic chemotherapy.Cytotoxic chemotherapy (medicines that kill fast growing cells) commonly causes neutropenia because as well as killing cancer cells, it also kills other fast-growing cells such as neutrophils, leaving the patient at risk of infections.Lonquex is not used in patients receiving chemotherapy for chronic myeloid leukaemia (a cancer of the white blood cells) and myelodysplastic syndromes (a disease that can develop into a leukaemia).

How is Lonquex used?

Lonquex is available as a solution for injection. It is given as an injection under the skin in the abdomen, upper arm or thigh. For adults and children weighing 45 kg or more, one 6-mg dose is given in each chemotherapy cycle around 24 hours after chemotherapy. For children weighing less than 45 kg, the dose is based on the child's weight.The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer and blood disorders. Patients or their carer may be able to inject the medicine themselves once they have been properly trained but the first injection should be given under the direct supervision of a doctor. For more information, see the package leaflet or contact your doctor or pharmacist.

How does Lonquex work?

The active substance in Lonquex, lipegfilgrastim, is similar to granulocyte colony stimulating factor (G-CSF), a naturally occurring protein in the body that stimulates the production of white blood cells including neutrophils in the bone marrow. Lipegfilgrastim acts in the same way as G-CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and the occurrence of febrile neutropenia in patients receiving chemotherapy.Lipegfilgrastim is a form of filgrastim, which has been available in the EU for a number of years. In Lonquex, filgrastim has been 'pegylated' (attached to a chemical called polyethylene glycol). This slows down the medicine's removal from the body and allows the medicine to be given less often.

What benefits of Lonquex have been shown in studies?

Lonquex was effective in reducing the duration of neutropenia and the number of febrile neutropenia cases among patients undergoing chemotherapy. In a main study involving 202 women with breast cancer, Lonquex compared well with another pegylated filgrastim: the average duration of severe neutropenia during chemotherapy was around 17 hours with Lonquex compared with around 19 hours with the other medicine. Lonquex also compared well with the other medicine in the number of febrile neutropenia cases: 1 in the Lonquex-treated group versus 3 in the comparator group.Another main study in 376 adult patients compared Lonquex with placebo (a dummy treatment). Patients receiving Lonquex recovered from neutropenia more quickly and fewer patients suffered severe neutropenia.Data on the way Lonquex works in the body showed that when given at the recommended dose to children aged 2 to 17 years who are receiving chemotherapy, the medicine is expected to lead to similar responses to those seen in adults.In addition, the effect of Lonquex on febrile neutropenia was investigated in two studies involving a total of 63 children between 2 and 17 years old with Ewing sarcoma (a cancer of the bone or nearby soft tissue) or rhabdomyosarcoma (a type of soft tissue cancer) who were undergoing chemotherapy.In the first study, febrile neutropenia occurred in 20% (4 out of 20) of the patients after one dose ofLonquex, which is comparable to the frequency seen with approved filgrastim treatments in children.In the second study, febrile neutropenia occurred in 35% (7 out of 20) of patients who received Lonquex compared with 42% (8 out of 19) of those given filgrastim. In addition, the average duration of febrile neutropenia seen with Lonquex was comparable to that seen with filgrastim (2.7 and 2.5 days, respectively).

What are the risks associated with Lonquex?

The most common side effects with Lonquex (which may affect more than 1 in 10 patients) are nausea as well as bone and muscle pain. For the full list of side effects of Lonquex, see the package leaflet.

Why is Lonquex authorised in the EU?

Lonquex has been shown to be effective in reducing the duration of severe neutropenia and the number of febrile neutropenia cases in adults. Lonquex has also been shown to behave in the same way in children aged 2 to 17 years as in adults and to show similar effects to a filgrastim treatment already approved in children. In addition, the less frequent dosing with Lonquex compared with that of filgrastim treatments for children is considered an advantage due to a lower treatment burden. The side effects of the medicine were typical for this class of medicines and are considered manageable. The Agency therefore decided that Lonquex'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 Lonquex?

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

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Lonsurf

What is Lonsurf and what is it used for?

Lonsurf is a medicine used to treat adults with colorectal cancer (cancer of the large bowel) and gastric (stomach) cancer. It is used when the cancer is metastatic (has spread to other parts of the body) in patients who have already been treated with, or who cannot be given, other treatments for their cancer.Lonsurf contains the active substances trifluridine and tipiracil.

How is Lonsurf used?

Treatment with Lonsurf should be prescribed by a doctor who is experienced in the use of cancer medicines. The medicine can only be obtained with a prescription.Lonsurf is available as tablets (15 mg trifluridine and 6.14 mg tipiracil; 20 mg trifluridine and 8.19 mg tipiracil) and is given in treatment cycles of 28 days. The dose is calculated using the patient's height and weight. The tablets are taken twice a day on certain days of each treatment cycle. They should be taken within one hour after morning and evening meals. The doctor may reduce the dose or interrupt treatment if certain side effects develop. Treatment with Lonsurf should continue for as long as benefits can be seen and the side effects are tolerable.For more information about using Lonsurf, see the package leaflet or contact your doctor or pharmacist.

How does Lonsurf work?

Lonsurf is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells). It contains two active substances: trifluridine and tipiracil.In the body, trifluridine is converted into an active form that is incorporated into DNA, the genetic material of cells. As a result, trifluridine interferes with DNA function and prevents the cells from dividing to make more cells.The conversion of trifluridine into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells. This reduces the growth of cancer cells, while normal cells are only slightly affected.Tipiracil increases the level of trifluridine in the blood by slowing its breakdown. This therefore boosts trifluridine's effect.

What benefits of Lonsurf have been shown in studies?

Lonsurf prolonged overall survival of patients with metastatic colorectal cancer and in patients with metastatic gastric cancer. All patients had previously received other treatments.Colorectal cancerIn one main study involving 800 patients, those treated with Lonsurf lived on average for 7.1 months compared with 5.3 months for patients who were treated with placebo (a dummy treatment). All patients received supportive care.Gastric cancerIn a study involving 507 adults with metastatic gastric cancer, patients treated with Lonsurf lived on average for 5.7 months compared with 3.6 months for patients who received placebo. All patients received supportive care.

What are the risks associated with Lonsurf?

The most common side effects with Lonsurf (which may affect more than 3 in 10 people) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), feeling sick, tiredness and anaemia (low red blood cell counts). The most serious side effects are bone marrow suppression (when the bone marrow produces fewer blood cells than normal) and effects on the gut (diarrhoea and feeling sick).For the full list of side effects and restrictions of Lonsurf, see the package leaflet.

Why is Lonsurf authorised in the EU?

The European Medicines Agency decided that Lonsurf's benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal and metastatic gastric cancer who have received previous treatment was important.Regarding its safety, although Lonsurf's side effects can be serious they are in line with what can be expected for this type of medicine. The Agency considered that the measures put in place are adequate to manage these risks.

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

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

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Lopinavir/Ritonavir Mylan

What is Lopinavir/Ritonavir Mylan and what is it used for?

Lopinavir/Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir.Lopinavir/Ritonavir Mylan is a 'generic medicine'. This means that it is similar to a 'reference medicine' already authorised in the European Union (EU), called Kaletra. For more information on generic medicines, see the question-and-answer document here.

How is Lopinavir/Ritonavir Mylan used?

Lopinavir/Ritonavir Mylan can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection. It is available as tablets (100 mg lopinavir and 25 mg ritonavir; 200 mg lopinavir and 50 mg ritonavir).In adults and adolescents (aged 12 years and over), the recommended dose of Lopinavir/Ritonavir Mylan is two 200/50-mg tablets twice a day. This dose is also suitable for children (aged between two and 12 years) provided that they weigh more than 40 kg or have a body surface area (calculated usingthe child's height and weight) over 1.4 m2. The dose for smaller children depends on the child's body surface area and the other medicines that the child is taking.For adults (aged 18 years or over) who are infected with HIV that is likely to respond to medicines in the same class as Lopinavir/Ritonavir Mylan (protease inhibitors) the doctor may prescribe the full daily dose of four 200/50-mg tablets as a single dose. When deciding to use once-daily dosing, the doctor should consider the fact that it might not be as effective as twice-daily dosing at keeping HIV levels low in the long term and may increase the risk of diarrhoea. For more information, see the package leaflet.

How does Lopinavir/Ritonavir Mylan work?

The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV. When the enzyme is blocked, the virus does not replicate normally, slowing down the spread of infection. In Lopinavir/Ritonavir Mylan, lopinavir provides the activity and ritonavir is used as a 'booster' that slows down the rate at which lopinavir is broken down by the liver. This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.Lopinavir/Ritonavir Mylan, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level. It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

How has Lopinavir/Ritonavir Mylan been studied?

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

What are the benefits and risks of Lopinavir/Ritonavir Mylan?

Because Lopinavir/Ritonavir 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 Lopinavir/Ritonavir Mylan approved?

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

What measures are being taken to ensure the safe and effective use of Lopinavir/Ritonavir Mylan?

A risk management plan has been developed to ensure that Lopinavir/Ritonavir Mylan 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 Lopinavir/Ritonavir Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.

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Lorviqua

What is Lorviqua and what is it used for?

Lorviqua is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the disease is advanced and ALK-positive, which means that the cancer cells have certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).Lorviqua is used on its own when the disease has not been treated before with other medicines of the same class, known as ALK tyrosine kinase inhibitors (TKIs).Lorviqua is also used on its own when the disease has worsened despite treatment with other ALK TKIs, including alectinib, ceritinib and crizotinib.Lorviqua contains the active substance lorlatinib.

How is Lorviqua used?

Lorviqua can only be obtained with a prescription. Treatment with Lorviqua should be started and supervised by a doctor who is experienced in using cancer medicines.The patient's cancer should be tested before starting treatment to confirm it has the genetic change affecting ALK.Lorviqua is available as tablets to be taken by mouth and the recommended dose is 100 mg once a day. If certain side effects develop the doctor may reduce the dose or interrupt treatment temporarily.Treatment may be stopped altogether if the disease gets worse or side effects become too severe.For more information about using Lorviqua, see the package leaflet or contact your doctor or pharmacist.

How does Lorviqua work?

ALK belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells and the development of new blood vessels that supply them. In patients with ALK-positive NSCLC, an abnormal form of ALK is produced that causes the cancer cells to divide and grow in an uncontrolled manner.The active substance in Lorviqua, lorlatinib, is a tyrosine kinase inhibitor. It works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer cells.

What benefits of Lorviqua have been shown in studies?

ALK-positive advanced NSCLC previously treated with an ALK TKILorviqua was effective at treating ALK-positive NSCLC in one main study which included 139 patients whose disease had worsened despite treatment with either alectinib or ceritinib or with crizotinib and another ALK TKI. In this study Lorviqua was not compared with any other treatment or placebo (a dummy treatment).Response to treatment was assessed using body scans and standardised criteria for assessing solid tumours, with complete response being when the patient had no remaining signs of the cancer. Around 43% of patients who had been previously treated with alectinib or ceritinib were considered by their doctors to have had a complete or partial response to Lorviqua.Of the patients who had been previously treated with crizotinib and another ALK TKI, around 40% had a complete or partial response to Lorviqua.Lorviqua was also effective when the cancer had spread to the brain. Depending on which previous treatment the patients had received, around 67% and 52% of patients treated with Lorviqua had no signs of cancer in the brain or the signs of cancer had reduced.Previously untreated ALK-positive advanced NSCLCOne main study, involving 296 patients with ALK-positive NSCLC who had not been treated before with another ALK TKI, found that Lorviqua was more effective than crizotinib in preventing the disease from getting worse.Patients given crizotinib got worse, on average, after around 9 months of treatment; as very few patients on Lorviqua got worse, it was not possible to calculate how many months passed before the disease worsened. The benefits of Lorviqua were further supported by study data showing that 76% of the patients given Lorviqua had a complete or partial response compared with 58% of patients receiving crizotinib. In addition, responses to Lorviqua lasted for longer compared with crizotinib.Lorviqua was also effective in patients whose cancer had spread to the brain. Around 66% of the patients treated with Lorviqua had no signs of cancer in the brain or the signs of cancer had reduced compared with around 20% of those receiving crizotinib.

What are the risks associated with Lorviqua?

The most common side effects with Lorviqua (which may affect more than 1 in 5 people) are hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type of fat), oedema (build-up of fluid), peripheral neuropathy (nerve damage in the hands and feet), weight gain, problems with thinking, learning and memory, tiredness, arthralgia (joint pain), diarrhoea and effects on mood. The most common serious side effects with Lorviqua (which may affect more than 1 in 100 people) are problems with thinking, learning and memory, and pneumonitis (inflammation in the lungs).Lorviqua must not be used together with medicines known as 'strong CYP3A4/5 inducers' because the combined medicines may damage the liver and reduce the amount of Lorviqua in the blood. For the full list of side effects and restrictions with Lorviqua, see the package leaflet.

Why is Lorviqua authorised in the EU?

Lorviqua is effective at treating patients with ALK-positive NSCLC that has not been treated before or has worsened despite treatment with other ALK TKIs. Lorviqua is also effective when the cancer has spread to the brain.Very few other treatments are available for patients with advanced ALK-positive NSCLC, and the side effects with Lorviqua are manageable.The European Medicines Agency therefore decided that Lorviqua's benefits are greater than its risks and it can be authorised for use in the EU.Lorviqua has been given 'conditional authorisation'. There is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Lorviqua?

Since Lorviqua has been given conditional authorisation, the company that markets Lorviqua will conduct a study with the medicine in patients whose disease has worsened after treatment with alectinib or ceritinib.

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

To further characterise the benefits of Lorviqua, the company that markets the medicine will provide the final results of the study comparing Lorviqua with crizotinib in patients with ALK-positive NSCLC who had not been treated before with another ALK TKI.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lorviqua have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lorviqua are continuously monitored. Side effects reported with Lorviqua are carefully evaluated and any necessary action taken to protect patients.

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Lucentis

What is Lucentis and what is it used for?

Lucentis is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula. The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces. The conditions Lucentis is used to treat are:• the 'wet' form of age-related macular degeneration (AMD). The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, which may leak fluid and blood and cause swelling);• other sight problems associated with choroidal neovascularisation;• macular oedema (swelling of the macula) caused by diabetes;• macular oedema caused by occlusion (blockage) of the veins behind the retina.

How is Lucentis used?

Lucentis is available as a solution for injection in prefilled syringes or vials, for single use. It is given by intravitreal injection (injection into the vitreous humour, the jelly-like fluid in the eye). It can only be obtained with a prescription and must be given by a qualified eye doctor who is experienced in giving intravitreal injections.The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection. The interval between two injections of Lucentis into the same eye must be at least four weeks. Before each injection, a local anaesthetic is given to reduce or prevent any pain from the injection, and the eye, eyelid and skin around the eye are disinfected. The prefilled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel the excess volume and ensure the injection of the correct dose.Treatment with Lucentis is started with one injection every month, with regular checks of the patient's vision and the appearance of the back of the eye, until maximum vision is achieved and/or there are no signs of disease activity; the monitoring and treatment intervals should then be determined by the treating doctor depending on the patient's condition and response. Treatment with Lucentis should be stopped if the patient is not benefitting from it.For more information about using Lucentis, see the package leaflet or contact your doctor or pharmacist

How does Lucentis work?

The active substance in Lucentis, ranibizumab, is a small piece of a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific target (called an antigen) that is found in certain cells in the body.Ranibizumab has been designed to attach to and block a substance called vascular endothelial growth factor A (VEGF-A). VEGF-A is a protein that makes blood vessels grow and leak fluid and blood, damaging the macula. By blocking this factor, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.

What benefits of Lucentis have been shown in studies?

AMDThree main studies of Lucentis involved 1,323 patients with the wet form of AMD. All of the patients were over 50 years of age and had not been treated for wet AMD before. Two of the studies compared Lucentis with a sham injection ( a procedure similar to a Lucentis injection, in which the syringe is pressed against the surface of the eye but no actual injection is carried out). The patients cannot tell whether they received Lucentis or the sham procedure. The third study compared Lucentis with verteporfin photodynamic therapy (PDT, another treatment for AMD). The main measure of effectiveness was the change in vision in the affected eye after a year of treatment, using a standard eye test with a letter chart. Patients were classified as having experienced no significant worsening of vision if the number of letters that they could see increased, stayed the same, or fell by less than 15.Lucentis was more effective at preventing a worsening of vision than the comparison treatment. After one year, between 94 and 96% of the AMD patients receiving Lucentis every month experienced no significant worsening of their vision, compared with 62% of those receiving sham injections and 64% of those treated with verteporfin PDT. The vision of patients receiving Lucentis also remained better than the vision of those receiving sham injections in a study in which injections were given less frequently, with injections every month for the first three months and then every three months.Choroidal neovascularisationFor choroidal neovascularisation other than that associated with wet AMD, Lucentis has been studied in 2 main studies each lasting a year. The main measure of effectiveness in both was the change in vision using a standard eye test with a letter chart. One study compared Lucentis with verteporfin PDT in 277 patients with choroidal neovascularisation associated with pathologic myopia (a severe type of short sightedness). On average over the first 3 months of treatment, patients given Lucentis could see around 8 to 9 letters more than those receiving verteporfin PDT.A second study involved 178 patients with choroidal neovascularisation associated with other conditions, and compared Lucentis with a sham injection. After 2 months of treatment, patients given Lucentis could see around 10 letters more on average than those given sham treatment.In both studies, the improvement in vision was maintained over the course of the study.Diabetic macular oedemaFor diabetic macular oedema, Lucentis was studied in two main studies involving a total of 454 patients. The first study compared Lucentis with a sham injection. The second study compared Lucentis, given on its own or as an add-on to laser photocoagulation (a treatment for diabetic macular oedema using a laser), with laser photocoagulation on its own.Lucentis was more effective at improving vision than its comparison treatments. In the first study, lasting one year, patients receiving Lucentis could see about 6 letters more than those receiving sham injections. In the second study, patients receiving Lucentis on its own or as an add-on to laser photocoagulation could see after one year an average of 5 letters more than patients receiving laser photocoagulation on its own.Macular oedema due to occlusion of retinal veinsFor macular oedema due to retinal vein occlusion, Lucentis was looked at in two main studies involving a total of 789 patients, where Lucentis was compared with a sham injection. In both studies, the main measure of effectiveness was the change in vision in the affected eye, measured by comparing the number of letters that the patient could see at the end of the treatment period with the number before starting treatment.Lucentis was more effective than a sham injection: patients receiving Lucentis at the 0.5 mg dose for six months could see around 11 letters more than patients receiving a sham injection in one study and 14 letters more in the other study.

What are the risks associated with Lucentis?

The most common side effects with Lucentis (seen in more than 1 in 10 patients) are increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the vitreous from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, eye pain, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (tear production), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (red eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat). Rarely, endophthalmitis (an infection inside the eye), blindness, serious damage to the retina and cataract (clouding of the lens) can occur. For the full list of all side effects of Lucentis, see the package leaflet.Lucentis must not be used in patients who may have an infection of the eye or the area around the eye, or who have severe inflammation within the eye. For the full list of restrictions, see the package leaflet.

Why is Lucentis authorised in the EU?

The European Medicines Agency decided that Lucentis'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 Lucentis?

The company that makes Lucentis will provide information packs to patients to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lucentis have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Lucentis are continuously monitored. Side effects reported with Lucentis are carefully evaluated and any necessary action taken to protect patients.

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Lumark

What is Lumark and what is it used for?

Lumark contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines. Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example, the site of a tumour.Lumark is to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.

How is Lumark used?

Lumark is only used by specialists who have experience in radiolabelling.Lumark is never given to a patient on its own. Radiolabelling with Lumark takes place in a laboratory. The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information.

How does Lumark work?

The active substance in Lumark, lutetium (177Lu) chloride, is a radioactive compound that mainly releases beta radiation, with small amounts of gamma radiation. When a medicine is radiolabelled with Lumark, the medicine carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used for diagnosis).

What benefits of Lumark have been shown in studies?

Because the use of lutetium (177Lu) to radiolabel medicines is well established, the company presented data from the scientific literature. Several published studies have established the usefulness of lutetium (177Lu) in radiolabelling medicines for diagnosing and treating neuroendocrine tumours. These tumours affect hormone-secreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.How well Lumark works will largely depend on the medicine that it is used to radiolabel.

What are the risks associated with Lumark?

The side effects with Lumark depend largely on the medicine it is used with and are described in that medicine's package leaflet. Lumark itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and hereditary defects. However, the quantity of Lumark to be used is very small and therefore these risks are considered low. The doctor will ensure that the expected benefit to the patients of using Lumark outweigh the risks linked to the radioactivity.The most common side effects with Lumark (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.Medicines radiolabelled with Lumark must not be used in women unless pregnancy has been ruled out. For the list of all side effects and restrictions with Lumark, see the package leaflet. Information on restrictions that apply specifically to medicines radiolabelled with Lumark can be found in the package leaflets of those medicines.

Why is Lumark authorised in the EU?

The European Medicines Agency considered that the use of lutetium (177Lu) for radiolabelling medicines was well established and well documented in the scientific literature. As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from Lumark. Information on how to minimise the risks is included in the product information for Lumark.The Agency concluded that the benefits of Lumark outweigh the risks and it can be authorised for use in the EU.

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

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

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Lumigan

What is Lumigan?

Lumigan is a clear eye drop solution that contains the active substance bimatoprost. It is available in two strengths, 0.1 and 0.3 mg per millilitre.

What is Lumigan used for?

Lumigan is used to reduce the pressure inside the eye. It is used in adults with long-term open angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal). Lumigan can be used alone or with beta-blocker eye drops (other medicines used for these conditions). The medicine can only be obtained with a prescription.

How is Lumigan used?

The recommended dose of Lumigan is one drop in the affected eye(s) once a day in the evening. If more than one type of eye drop is being used, each one should be given at least five minutes apart.

How does Lumigan work?

When the pressure inside the eye is raised, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can result in serious loss of vision and even blindness. The active substance in Lumigan, bimatoprost, is a prostaglandin analogue (a man-made copy of a natural substance, prostaglandin). In the eye, prostaglandin increases the drainage of the watery fluid (aqueous humour) out of the eyeball. Lumigan acts in the same way and increases the flow of fluid out of the eye. This helps to reduce the pressure inside the eye and the risk of damage.

How has Lumigan been studied?

Lumigan has been studied in adults with glaucoma or ocular hypertension.Lumigan 0.3 mg/ml used on its own has been compared with timolol (a beta-blocker used to treat glaucoma) in two 12-month studies involving a total of 1,198 patients. Some of these patients carried on receiving the medicines for up to two or three years (379 and 183 patients, respectively). It has also been compared with latanoprost (another prostaglandin analogue used in glaucoma) in a six-month study involving 269 patients. The effect of adding Lumigan 0.3 mg/ml to existing treatment with a beta-blocker eye drop has been compared with that of adding placebo (a dummy eye drop) in onestudy involving 285 patients. Lumigan's effect when added to beta-blocker treatment has also been compared with that of latanoprost in another study in 437 patients.An additional 12-month study compared Lumigan 0.1 mg/ml with Lumigan 0.3 mg/ml, and with an intermediate strength of 0.125 mg/ml, in 561 patients.In all of the studies, the main measure of effectiveness was the reduction in eye pressure. Eye pressure is measured in 'millimetres of mercury' (mmHg). In a patient with ocular hypertension or glaucoma, the value is generally higher than 21 mmHg.

What benefit has Lumigan shown during the studies?

Lumigan 0.3 mg/ml on its own was more effective than timolol at reducing eye pressure. This effect was maintained after two or three years of treatment, with an average reduction in eye pressure of between 7.1 and 8.6 mmHg with Lumigan used once a day, compared with 4.6 to 6.4 mmHg with timolol. Lumigan 0.3 mg/ml was also more effective than latanoprost, with patients using Lumigan achieving a reduction in eye pressure of 6.0 to 8.2 mmHg after six months of treatment compared with 4.9 to 7.2 mmHg with latanoprost.Adding Lumigan 0.3 mg/ml to existing treatment with a beta-blocker was more effective than continuing to use the beta-blocker on its own. After three months, eye pressure was lowered by 7.4 mmHg in the group adding Lumigan, compared with 3.6 mmHg in the group adding placebo. Lumigan was as effective as latanoprost when added to beta-blocker treatment, with reductions in eye pressure of 8.0 and 7.4 mmHg, respectively, after three months.Lumigan 0.1 mg/ml brought about slightly smaller decreases in IOP than Lumigan 0.3 mg/ml. However, the lower strength formulation was better tolerated and was less likely to cause hyperaemia (redness of the eye).

What is the risk associated with Lumigan?

The most common side effects with Lumigan (seen in more than 1 patient in 10) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness). In addition, the following side effects are also seen in more than 1 patient in 10 using Lumigan 0.3 mg/ml: growth of eyelashes and ocular pruritus (itchy eye). For the full list of all side effects reported with Lumigan, see the Package Leaflet.Lumigan should not be used in people who may be hypersensitive (allergic) to bimatoprost or any of the other ingredients.Lumigan contains benzalkonium chloride, which is known to discolour soft contact lenses. Therefore, care should be taken by people who wear soft contact lenses. Because Lumigan 0.1 mg/ml contains higher levels of benzalkonium chloride than Lumigan 0.3 mg/ml, Lumigan 0.1 mg/ml must not be used in people who have had a reaction to a product containing benzalkonium chloride in the past, and had to stop using the product containing it as a result.

Why has Lumigan been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Lumigan's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Luminity

What is Luminity?

Luminity is a solution for injection or infusion (drip) into a vein that contains microspheres (tiny bubbles) of perflutren gas as the active substance.

What is Luminity used for?

Luminity is for diagnostic use only. It is a contrast agent (a medicine that helps obtain better images of organs and tissues during a scan).Luminity is used in adults to obtain a clearer image of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound). Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained without a contrast agent is not good enough.The medicine can only be obtained with a prescription.

How is Luminity used?

Luminity should only be given by doctors trained in performing and reading images obtained with contrast echocardiography, in hospitals or clinics where appropriate resuscitation equipment is available in case of heart or lung problems or allergic reactions.Send aBefore use, Luminity must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine. This ensures that the medicine is shaken in the correct way and for long enough to make up a 'dispersion' of microspheres of perflutren gas of the right size to get a good quality image. This is then given into a vein either as a 'bolus' injection (given all at once) or as an infusion after being diluted. The way Luminity is given and the dose depend on the technique being used for the echocardiography.For full details, see the summary of product characteristics (also part of the EPAR).

How does Luminity work?

When Luminity is injected, it travels in the veins to the heart. During echocardiography, the perflutren microspheres in Luminity reflect ultrasound waves differently from the surrounding tissues. This helps to obtain a better contrast between the area where the gas bubbles are (such as the heart chambers) and the surrounding tissue. The gas is then cleared through the lungs.

How has Luminity been studied?

There have been five main studies of Luminity, involving a total of 401 patients. Three studies looked at its ability to enhance the image of the left ventricle, comparing the echocardiography scan before and after administration of Luminity. In two of these studies, Luminity was compared with placebo (a dummy treatment). The last two studies were set up primarily to look at the ability of Luminity to improve the accuracy of the measurement of the ejection fraction (the percentage of the blood volume that is pumped out of the heart in one beat). These studies also looked at left ventricle image enhancement.

What benefit has Luminity shown during the studies?

Luminity was effective in enhancing the image of the left ventricle, and it was more effective than placebo in the studies where Luminity and placebo were compared. As all five original studies were carried out with a technique known as 'fundamental' ultrasound imaging, the company also presented the results of some studies to show that the results seen using fundamental imaging could also be obtained when using the imaging techniques known as 'harmonic' and 'non linear'.

What is the risk associated with Luminity?

The most common side effects with Luminity (seen in between 1 and 10 patients in 100) are headache and flushing (reddening of the skin). For the full list of all side effects and restrictions with Luminity, see the package leaflet.

Why has Luminity been approved?

The CHMP decided that Luminity'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 Luminity?

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

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Lumykras

What is Lumykras and what is it used for?

Lumykras is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the cancer is advanced, and its cells have a particular genetic change. The change is in the gene KRAS and is known as 'KRAS G12C'. Lumykras is given when the disease has progressed after receiving systemic treatment (treatment affecting the whole body).Lumykras contains the active substance sotorasib.

How is Lumykras used?

The medicine can only be obtained with a prescription, and treatment with Lumykras should be started by a doctor who is experienced in using cancer medicines.The patient's cancer should be tested before starting treatment to confirm it has the genetic change affecting KRAS (KRAS G12C).Lumykras is available as tablets and is taken by mouth. The recommended dose is 960 mg once per day. Treatment is continued until the disease gets worse or side effects become too severe.If certain side effects develop, the doctor may decide to reduce the dose to 480 mg once per day and then, if needed, to 240 mg once per day. Treatment should be stopped if side effects are too great at the lowest dose (240 mg).For more information about using Lumykras, see the package leaflet or contact your doctor or pharmacist.

How does Lumykras work?

Genetic changes to the KRAS gene can produce an altered protein that causes the uncontrolled growth of cancer cells. The active substance in Lumykras, sotorasib, attaches to this altered protein inside cancer cells. This blocks the protein from acting, interrupting the chemical messages the cancer cells need for growing and spreading, and it also encourages processes that cause the cancer cells to die.

What benefits of Lumykras have been shown in studies?

In one main study involving 124 patients, Lumykras was effective in treating adults with NSCLC with the KRAS G12C genetic change whose disease had progressed after previously being treated with other cancer medicines. Lumykras was not compared with any other treatment or placebo (a dummy treatment).Response to treatment (shrinkage in the size of the cancer) was assessed using body scans. Around 37% (46 out of 124) of the patients showed partial or complete cancer shrinkage after treatment with Lumykras. On average, responses lasted for just over 11 months.

What are the risks associated with Lumykras?

The most common side effects with Lumykras (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick) and tiredness. The most common severe side effects with Lumykras (which may affect up to 1 in 100 people) are increased levels of certain liver enzymes (a sign of possible liver problems) and liver injury. For the full list of side effects and restrictions of Lumykras, see the package leaflet.

Why is Lumykras authorised in the EU?

There are currently few treatment options for patients with advanced NSCLC with KRAS G12C mutations for whom the cancer has progressed after systemic treatment with cancer medicines, and current treatments have limited effectiveness. Although the main study did not compare Lumykras with another cancer treatment, it showed that the medicine was effective at treating the cancer including in patients whose cancer had progressed after several different treatments. In general, Lumykras' side effects were considered manageable.The European Medicines Agency, therefore, decided that Lumykras' benefits are greater than its risks and it can be authorised for use in the EU.Lumykras has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Lumykras?

Since Lumykras has been given conditional authorisation, the company that markets Lumykras will provide further information from an ongoing study. The study will compare the efficacy and safety of Lumykras in treating previously treated NSCLC with KRAS G12C mutation with those of another cancer medicine, docetaxel.

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

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

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Lunsumio

What is Lunsumio and what is it used for?

Lunsumio is a cancer medicine used to treat adults with follicular lymphoma that does not respond to (refractory) or has come back (relapsed) after at least two previous treatments.Follicular lymphoma is rare, and Lunsumio was designated an 'orphan medicine' (a medicine used in rare diseases) on 16 November 2021. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/EU3212517.Lunsumio contains the active substance mosunetuzumab.

How is Lunsumio used?

Lunsumio can only be obtained with a prescription and must be given under the supervision of a doctor who is qualified in the use of cancer medicines, in a location with appropriate medical support to manage severe side effects such as cytokine release syndrome (see risks section below).Lunsumio is given as an infusion (drip) into a vein. Infusions with Lunsumio should be given once a week in the first cycle, then once every three weeks for subsequent cycles (each cycle takes three weeks), for a total of 8 treatment cycles. However, depending on side effects and how the disease responds to treatment, up to 17 cycles may be given. For the first cycle, infusions should last four hours, but subsequent infusions may be given more quickly if treatment is tolerated well. The doctor may interrupt or stop treatment if the patient develops certain serious side effects.For more information about using Lunsumio, see the package leaflet or contact your doctor or pharmacist.

How does Lunsumio work?

Follicular lymphoma is a cancer that affects a type of white blood cell called B lymphocyte. The active substance in Lunsumio, mosunetuzumab, is a monoclonal antibody (a type of protein) that has been designed to attach to CD20, a protein found on B lymphocytes, including the cancer cells, and to CD3, a protein on T cells (a different type of white blood cell). T cells are a part of the body's defences and help protect the body from infection. They can also destroy cancer cells.By binding to the CD20 and CD3 proteins, the medicine acts like a bridge to bring together the cancer cells and T cells. This encourages the T cells to destroy the cancer cells and helps control the disease.

What benefits of Lunsumio have been shown in studies?

The benefits of Lunsumio were evaluated in a study in adults with relapsed or refractory follicular lymphoma who had received at least two previous therapies. In this study, Lunsumio was not compared with other medicines. In response to treatment, the cancer shrank or disappeared in 80% (72 out of 90) of patients, while 60% (54 out of 90) of patients achieved a complete response (no sign of cancer). On average, responses lasted for at least 12 months in 62% of patients.

What are the risks associated with Lunsumio?

The most common side effects with Lunsumio (which may affect more than 2 in 10 people) are cytokine release syndrome (a potentially life-threatening condition causing fever, vomiting, shortness of breath, headache and low blood-pressure), neutropenia (low levels of neutrophils, a type of white blood cell), fever, low levels of phosphate in the blood and headache. The most common serious side effects included cytokine release syndrome, fever and pneumonia (infection of the lungs).For the full list of side effects and restrictions of Lunsumio, see the package leaflet.

Why is Lunsumio authorised in the EU?

Patients with relapsed or refractory follicular lymphoma have limited treatment options. Treatment with Lunsumio resulted in a complete response in a high proportion of these patients, and side effects were considered generally manageable and acceptable. The European Medicines Agency therefore decided that Lunsumio's benefits are greater than its risks and that it can be authorised for use in the EU.Lunsumio has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available. This medicine overview will be updated as necessary.

What information is still awaited for Lunsumio?

Since Lunsumio has been given conditional authorisation, the company that markets Lunsumio will provide results from an ongoing study comparing Lunsumio with rituximab, both given with lenalidomide, in patients with follicular lymphoma who had at least one previous treatment for their disease.

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

The company that markets Lunsumio must provide patient cards with information about key signs and symptoms of cytokine release syndrome, and when and where to seek help if such signs occur. This card will also inform healthcare professionals that the patient is receiving Lunsumio.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lunsumio have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lunsumio are continuously monitored. Suspected side effects reported with Lunsumio are carefully evaluated and any necessary action taken to protect patients.

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Lupkynis

What is Lupkynis and what is it used for?

Lupkynis is a medicine used to treat lupus nephritis, a manifestation of a disease called systemic lupus erythematosus. In lupus nephritis, the immune system (the body's natural defences) attacks the kidneys, causing inflammation and kidney damage.Lupkynis is used together with another medicine called mycophenolate mofetil in adults with active class III, IV or V lupus nephritis, which are severe forms of the condition.Lupkynis contains the active substance voclosporin.

How is Lupkynis used?

The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in diagnosing and treating lupus nephritis.Lupkynis is available as a 7.9 mg capsule to be taken by mouth. The recommended dose is 23.7 mg (equivalent to three soft capsules) twice a day, with a minimum of 8 hours between each dose. The doctor should evaluate treatment effectiveness after about 24 weeks and weigh it against the risks to decide whether to continue treatment.For more information about using Lupkynis, see the package leaflet or contact your doctor or pharmacist.

How does Lupkynis work?

The active substance in Lupkynis, voclosporin, is an immunosuppressant (a medicine that reduces the activity of the immune system) known as a calcineurin inhibitor. This means that it blocks the action of calcineurin, an enzyme involved in activating T-lymphocytes (white blood cells that are part of the immune system and play a role in inflammation). By blocking the action of calcineurin, voclosporin reduces inflammation and other symptoms of lupus nephritis.

What benefits of Lupkynis have been shown in studies?

Lupkynis was shown to be more effective than placebo (a dummy treatment) in achieving stable kidney function in adults with active lupus nephritis. A main study involving 357 adults found that after 52 weeks, 41% (73 out of 179) of patients taking Lupkynis had acceptable measures of both kidney function and protein in the urine (a sign of kidney damage) compared with 23% (40 out of 178) of patients receiving placebo. All patients received mycophenolate mofetil (another immunosuppressant medicine) in addition to Lupkynis or placebo.

What are the risks associated with Lupkynis?

The most common side effects with Lupkynis (which may affect more than 1 in 10 people) are decreased glomerular filtration rate (a sign of kidney damage) and hypertension (high blood pressure).The most common serious side effects with Lupkynis are infections, acute kidney injury and high blood pressure.Lupkynis must not be used together with certain medicines called 'strong CYP3A4 inhibitors', including the antifungal medicines ketoconazole and itraconazole and the antibiotic medicine clarithromycin, as these may affect the levels of voclosporin in the blood.For the full list of side effects and restrictions with Lupkynis, see the package leaflet.

Why is Lupkynis authorised in the EU?

When used in combination with mycophenolate mofetil, Lupkynis has been shown to be effective in achieving stable kidney function in adults with active lupus nephritis. The medicine's side effect profile is serious and requires extensive monitoring of kidney function; adequate information on the risks and recommendations for monitoring is included in the product information. The European Medicines Agency therefore decided that Lupkynis'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 Lupkynis?

The company will carry out a study to provide more information on the long-term safety of Lupkynis.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lupkynis have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lupkynis are continuously monitored. Suspected side effects reported with Lupkynis are carefully evaluated and any necessary action taken to protect patients.

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Lutathera

What is Lutathera and what is it used for?

Lutathera is a cancer medicine for treating tumours in the gut known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs). It is a radiopharmaceutical (a medicine that emits a small amount of radioactivity).Lutathera is used is to treat GEP-NETs that cannot be removed by surgery, have spread to other parts of the body or are not responding to treatment.The medicine is only for GEP-NETs that have receptors called somatostatin receptors on their cell surfaces.Because the number of patients with GEP-NETs is low, they are considered 'rare', and Lutathera was designated an 'orphan medicine' (a medicine used in rare diseases) on 31 January 2008.Lutathera contains the active substance lutetium (177Lu) oxodotreotide.

How is Lutathera used?

Because Lutathera emits some radioactivity, it is only used in special controlled areas and must be handled and given to patients by qualified personnel. The patient cannot leave the controlled areas until told to do so by the doctor.Before starting treatment, the doctor will have checked that the patient's tumours have somatostatin receptors on their cell surfaces. Lutathera is given by infusion (drip) into a vein. The usual treatment involves 4 infusions 8 weeks apart, but the gap between infusions can be increased to up to 16 weeks if the patient gets severe side effects. The patient should also be given an infusion of an amino acid solution which helps protect their kidneys.For further information, including information on the precise method for giving the infusions, see the package leaflet.

How does Lutathera work?

The active substance in Lutathera, lutetium (177Lu) oxodotreotide, works by attaching to somatostatin receptors, which are found in high numbers in some GEP-NETs. The radioactivity it emits then kills the tumour cells it is attached to but has little effect on neighbouring cells.

What benefits of Lutathera have been shown in studies?

Lutathera can help slow down the worsening of GEP-NETs. In a main study of 229 patients with GEP-NETs that contained somatostatin receptors, patients given Lutathera lived for an average of 28 months without their disease getting worse. This compares with around 9 months for patients treated with octreotide, a medicine already approved for treating the condition.

What are the risks associated with Lutathera?

The most common side effects seen with Lutathera treatment are nausea and vomiting, which occurred at the start of the infusions in around half of patients and may be related to the amino acid infusion. Other common side effects affecting more than 1 in 10 patients are thrombocytopenia (low platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia (low red cell counts), pancytopenia (low levels of all types of blood cells), tiredness and reduced appetite. For the full list of all side effects reported with Lutathera, see the package leaflet.Lutathera must not be given to women who are pregnant or in whom pregnancy has not been excluded. It must also not be given to patients with severely reduced kidney function. For the full list of restrictions, see the package leaflet.

Why is Lutathera approved?

Only a minority of patients with GEP-NETs can be cured with surgery and at the time of diagnosis the tumours would have spread in most patients. Lutathera can help slow the worsening of the condition and its side effects are considered manageable.The European Medicines Agency considered that the benefits seen with Lutathera outweigh its risks and recommended it be approved in the EU.

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

The company that markets Lutathera will put in place an educational programme for patients to ensure they understand the risk of radioactivity and precautions they should take to limit exposure to themselves and people around them.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lutathera have also been included in the summary of product characteristics and the package leaflet.

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Lutetium (177Lu) Chloride Billev

What is Lutetium (177Lu) chloride Billev and what is it used for?

Lutetium (177Lu) chloride Billev is a solution containing a radioactive form of lutetium (177lu) that is used for radiolabelling other medicines. Radiolabelling is a technique where a substance is labelled with a radioactive compound. Once the substance is radiolabelled with Lutetium (177Lu) chloride Billev, it then carries the radioactivity to where it is needed in the body (for example, the site of a tumour).Lutetium (177Lu) chloride Billev is used to radiolabel medicines that have been specifically developed for use with lutetium (177lu) chloride.Lutetium (177Lu) chloride Billev contains the active substance lutetium (177lu) chloride.

How is Lutetium (177Lu) chloride Billev used?

Lutetium (177Lu) chloride Billev is only to be used by specialists who have experience in radiolabelling. Lutetium (177Lu) chloride Billev is never given directly to a patient. Radiolabelling of a medicine takes place in a laboratory setting. The radiolabelled medicine is then given to the patient according to the instructions in that medicine's summary of product characteristics (SmPC).

How does Lutetium (177Lu) chloride Billev work?

The active substance in Lutetium (177Lu) chloride Billev, lutetium (177lu) chloride, is a radioactive compound that emits mainly a type of radiation known as 'beta-minus', for treatment, and a small amount of gamma radiation, for imaging. When a medicine is radiolabelled with Lutetium (177Lu) chloride Billev, the medicine will carry the radiation to the particular site or type of cell in the body that is targeted by the medicine.

What benefits of Lutetium (177Lu) chloride Billev have been shown in studies?

The company presented information from published clinical studies on the potential uses of Lutetium (177Lu) chloride Billev. Some of the data presented showed the usefulness of 177Lu in radiolabelling medicines for treating neuroendocrine tumors and prostate cancer, used together with imaging techniques to detect the site and spread of tumours.

What are the risks associated with Lutetium (177Lu) chloride Billev?

The side effects with Lutetium (177Lu) chloride Billev depend largely on the medicine it has been used to radiolabel and will be described in that medicine's package leaflet. Lutetium (177Lu) chloride Billev itself is radioactive and so its use in radiolabelling may carry a risk of developing cancer and hereditary defects. The doctor will ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.The most common side effects (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and hair loss.Lutetium (177Lu) chloride Billev must not be given directly to any patient. It must not be used in women who are known to be or may be pregnant, and when pregnancy has not been ruled out. For the full list of restrictions of Lutetium (177Lu) chloride Billev, see the package leaflet.Information on the restrictions on the use of medicines radiolabelled with Lutetium (177Lu) chloride Billev can be found in the respective package leaflets.

Why is Lutetium (177Lu) chloride Billev authorised in the EU?

The European Medicines Agency decided that Lutetium (177Lu) chloride Billev's benefits for radiolabelling medicines are greater than its risks and it can be authorised for use in the EU. Given the well-known risks linked to radiation exposure, the Agency concluded Lutetium (177Lu) chloride Billev is only to be used if justified by the likely medical benefit.

What measures are being taken to ensure the safe and effective use of Lutetium (177Lu) chloride Billev?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lutetium (177Lu) chloride Billev have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lutetium (177Lu) chloride Billev are continuously monitored. Suspected side effects reported with Lutetium (177Lu) chloride Billev are carefully evaluated and any necessary action taken to protect patients.

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Luveris

What is Luveris?

Luveris is a medicine that contains the active substance lutropin alfa. It is available as a powder and solvent that are made up into a solution for injection, and as a solution for injection in a pre-filled pen.

What is Luveris used for?

Luveris is a fertility treatment. It is used with follicle stimulating hormone (FSH) to stimulate the development of eggs in the ovaries of adult women who have severe deficiency (very low levels) of luteinising hormone (LH) and FSH.The medicine can only be obtained with a prescription.

How is Luveris used?

Treatment with Luveris should be carried out by a doctor who has experience in the treatment of fertility problems.Luveris is given once a day together with FSH. The patient's response to treatment is monitored to check how the egg development in the ovary is progressing. Doses of FSH are adjusted according to the response, and treatment may continue for up to five weeks. Luveris is given by injection under the skin. The patient may carry out the injection herself if she is well-motivated, has been adequately trained and has access to expert advice.If the powder and solvent are used, they should be mixed together just before use. The resulting solution can be mixed with FSH in the same syringe.

How does Luveris work?

The active substance in Luveris, lutropin alfa, is a copy of the natural hormone LH. In the body, LH causes the release of eggs (ovulation) during the menstrual cycle. FSH, which is used together with Luveris, also stimulates ovulation.Lutropin alfa is produced by a method known as 'recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human LH.

How has Luveris been studied?

Luveris, given together with FSH, has been studied in one main study involving 38 women with severe LH and FSH deficiency. Because the number of patients with this condition is low, Luveris was not compared with any other medicines. The main measure of effectiveness was the number of women who produced functional follicles (eggs in the ovaries that are ready for release).

What benefit has Luveris shown during the studies?

In the main study, 67% of the women who received the approved dose of Luveris (75 International Units) together with FSH produced functional follicles (6 out of 9). Higher doses were no more effective than this dose.

What is the risk associated with Luveris?

The most common side effects with Luveris (seen in between 1 and 10 patients in 100) are reactions at the injection site (pain, redness, bruising or swelling), headache,, nausea (feeling sick), vomiting, diarrhoea, abdominal pain and discomfort, pelvic (lower abdominal) pain, mild to moderate ovarian hyperstimulation syndrome, ovarian cyst (development of a fluid-filled cavity in the ovary) and breast pain. Ovarian hyperstimulation syndrome occurs when the ovaries over respond to treatment, especially when medicines to trigger ovulation have been used, and can cause nausea, weight gain and diarrhoea. For the full list of all side effects reported with Luveris, see the package leaflet.Luveris should not be used in people who may be hypersensitive (allergic) to LH, FSH or any of the other ingredients. It must not be used in women who have tumours of the pituitary gland, hypothalamus (a region of the brain), breast, womb or ovary. It must also not be used when there is enlargement of the ovaries or cysts that are not related to polycystic ovarian disease and are of unknown origin, or unexplained bleeding from the vagina. For the full list of restrictions, see the package leaflet.

Why has Luveris been approved?

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

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Luxturna

What is Luxturna and what is it used for?

Luxturna is a medicine that is used to treat adults and children with loss of vision due to inherited retinal dystrophy, a rare genetic disorder of the retina (the light sensitive membrane at the back of the eye).Luxturna can only be used while patients still have enough functioning cells left in the retina and when the disease is caused by mutations (changes) in the gene RPE65. RPE65 is responsible for the production of an enzyme called all-trans retinyl isomerase, which is necessary for the normal functioning of retinal cells.Luxturna contains the active substance voretigene neparvovec and is a type of advanced therapy medicine called a 'gene therapy product'. This is a type of medicine that works by delivering genes into the body.Inherited retinal dystrophy is rare, and Luxturna was designated an 'orphan medicine' (a medicine used in rare diseases) for two forms of the disease on various dates (retinitis pigmentosa: 28 July 2015; Leber's congenital amaurosis: 2 April 2012). Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/medicines/human/orphandesignations.

How is Luxturna used?

Luxturna can only be obtained with a prescription and treatment should be given by a surgeon experienced in performing eye surgery.Luxturna is given as a single injection into the back of each eye, under the retina. The second eye should be treated at least 6 days after the first. Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body's natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection.For more information about using Luxturna, see the package leaflet or contact your doctor or pharmacist.

How does Luxturna work?

Luxturna consists of a virus that contains normal copies of the RPE65 gene. When Luxturna is injected into the eye the virus carries the RPE65 gene into the retinal cells and enables them to produce the missing enzyme. This helps the cells in the retina to function better, slowing down the progression of the disease.The type of virus used in this medicine (adeno-associated virus) does not cause disease in humans.

What benefits of Luxturna have been shown in studies?

Luxturna was investigated in one main study involving 31 patients with inherited retinal dystrophy due to RPE65 mutations. The main measure of effectiveness was how well patients performed in a mobility test, where they were required to navigate a route with turns and obstacles under various light settings. Patients were considered to have passed the test if they completed the route within 3 minutes and bumped into no more than 3 obstacles.After one year of treatment, patients treated with Luxturna improved their scores by 1.8 points, while patients who were not given Luxturna improved their scores by 0.2 points, meaning that patients treated with Luxturna were able to move better along the route. Additionally, 13 of the 21 patients (62%) treated with Luxturna passed the mobility test at the lowest light level of 1 lux (similar to conditions of a poorly lit pavement at night), while none of the patients not given the medicine were able to do so. The improvement in patients' vision was maintained for at least three years.

What are the risks associated with Luxturna?

The most common side effects with Luxturna (which may affect more than 1 in 20 people) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye), cataract (clouding of the lens of the eye) and increased pressure inside the eye. For the full list of side effects of Luxturna, see the package leaflet.Luxturna must not be used in patients with eye infection or inflammation. For the full list of restrictions, see the package leaflet.

Why is Luxturna authorised in the EU?

Luxturna has been shown to improve patients' vision and ability to move around obstacles, particularly in dim light, and is expected to improve their quality of life. This was considered an important clinical benefit, taking into account the lack of authorised treatments for this progressive, degenerative condition. The safety of Luxturna was considered acceptable and side effects manageable. Therefore, the European Medicines Agency decided that Luxturna'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 Luxturna?

The company that markets Luxturna will set up an educational programme and prepare educational material aimed at doctors and pharmacists expected to use and handle Luxturna, in order to ensure the correct use of the medicine and minimise the risks associated with the medicine and its administration. Luxturna will only be available from centres where the educational programme is in place. An information package for patients and their carers will also be provided.In addition, the company will have to follow-up all patients who received Luxturna in the main studies for 15 years, in order to characterise the long-term effectiveness and safety of the medicine, and establish a registry to collect long-term safety data in patients treated with Luxturna.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luxturna have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Luxturna are continuously monitored. Side effects reported with Luxturna are carefully evaluated and any necessary action taken to protect patients.

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Lydisilka

What is Lydisilka and what is it used for?

Lydisilka is a combined hormonal contraceptive. It contains the active substances drospirenone and estetrol monohydrate.

How is Lydisilka used?

Lydisilka can only be obtained with a prescription. It comes in blisters containing 28 tablets (24 'active' tablets and 4 'inactive' tablets that do not contain the active substances).Tablets are taken by mouth in sequence, starting on the first day of the menstrual cycle with the active tablets, followed by the 4 inactive tablets. Each subsequent pack is started the day after finishing the previous pack, for as long as contraception is required. For more information about using Lydisilka, see the package leaflet or contact your doctor, pharmacist or prescriber.

How does Lydisilka work?

Lydisilka is a combined contraceptive pill that contains two active substances, drospirenone (a progestogen) and estetrol (an oestrogen). Estetrol is a synthetic version of an oestrogen that is naturally present during pregnancy, and drospirenone is a hormone with similar effects to the progesterone produced during the menstrual cycle. Both these substances change the body's hormonal balance to prevent ovulation.

What benefits of Lydisilka have been shown in studies?

Lydisilka was found to be effective at preventing unwanted pregnancies in 2 main studies involving a total of around 3,400 women.The main measure of effectiveness was the number of unwanted pregnancies in 100 women-years (corresponding to 100 women taking contraception for one year). This measure is known as the Pearl Index, and a lower Pearl Index represents a lower chance of getting pregnant.In a first study conducted in 1,553 women between the ages of 18 and 50, the Pearl Index was 0.44 in the group aged 18 to 35 and 0.38 in the whole group. This was considered a sufficiently low value for an oral contraceptive.In a second study, conducted in 1,864 women aged 16 to 50 years old, where more pregnancies were reported, the Pearl Index was 2.42 in women aged 16 to 35 and 2.30 in the group aged 16 to 50.

What are the risks associated with Lydisilka?

The most common side effects with Lydisilka (which may affect up to 1 in 10 people) are irregular bleeding between periods (metrorrhagia), headache, acne, vaginal bleeding and painful periods (dysmenorrhoea). For the full list of side effects of Lydisilka, see the package leaflet.Lydisilka should not be used by women with a history of blood clots in the veins or arteries, or by women with risk factors for blood clots. It should also not be used by women who have experienced severe liver and kidney problems, liver tumours, hormone-dependent cancers, or abnormal bleeding from the genital area of unknown cause. For the full list of restrictions, see the package leaflet.

Why is Lydisilka authorised in the EU?

Overall, Lydisilka was considered effective at preventing unwanted pregnancies. In terms of safety, the side effects of Lydisilka are similar to those of other combined hormonal contraceptives and are in line with what would be expected with an oestrogen and a progestogen pill. The European Medicines Agency therefore decided that Lydisilka'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 Lydisilka?

The company that markets Lydisilka will provide a checklist for healthcare professionals and an information card for women to help manage the risk of thromboembolic events.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lydisilka have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lydisilka are continuously monitored. Side effects reported with Lydisilka are carefully evaluated and any necessary action taken to protect patients.

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Lyfnua

What is Lyfnua and what is it used for?

Lyfnua is a medicine used to treat adults with chronic (long-term) cough which is unexplained or for which other treatments have not worked.The medicine contains the active substance gefapixant.

How is Lyfnua used?

Lyfnua is available as tablets to be taken by mouth twice a day; it can only be obtained with a prescription.For more information about using Lyfnua, see the package leaflet or contact your doctor or pharmacist.

How does Lyfnua work?

In response to inflammation or airway irritation, cells within the lining of the airways produce high levels of a substance called ATP. ATP attaches to specific receptors (targets) on nerve cells in the airways, which stimulates the nerves and triggers the urge to cough. The active substance in Lyfnua, gefapixant, blocks these receptors and keeps the nerves from triggering the cough reflex.

What benefits of Lyfnua have been shown in studies?

The benefits of Lyfnua were investigated in two main studies involving 1,360 adults with chronic cough, who were given Lyfnua or placebo (a dummy treatment). Lyfnua was shown to be more effective than placebo at lowering the average number of times patients coughed per hour, measured over a 24-hour period. In the first study, after 12 weeks of treatment, the average number of coughs per hour in patients given Lyfnua went from 18.2 to 7.1 (a reduction of 61%) compared with a decrease from 22.8 to 10.3 (a reduction of 55%) in patients given placebo. In the second study, after 24 weeks of treatment, the average number of coughs per hour went from 18.6 to 6.8 (a reduction of 63%) in patients given Lyfnua compared with a decrease from 19.5 to 8.3 (a reduction of 57%) in patients given placebo.

What are the risks associated with Lyfnua?

For the full list of side effects and restrictions with Lyfnua, see the package leaflet.The most common side effects with Lyfnua (which may affect more than 1 in 10 people) include taste disorders: dysgeusia (changes in the sense of taste), ageusia (loss of sense of taste) and hypogeusia (reduced sense of taste).

Why is Lyfnua authorised in the EU?

Lyfnua showed a modest effect in terms of reducing the number of daily coughs in patients with chronic cough. Side effects with Lyfnua are considered manageable; the most common side effects concerned taste disorders and these generally resolved once patients stopped treatment. The European Medicines Agency therefore decided that Lyfnua'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 Lyfnua?

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

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Lymphoseek

What is Lymphoseek and what is it used for?

Lymphoseek is a diagnostic medicine used in patients with cancer to identify sentinel lymph nodes. The sentinel lymph nodes are the regional lymph nodes where the cancer is likely to spread to first. When sentinel lymph nodes are found they are removed surgically and checked for cancer cells. This helps to decide if further surgery to remove more lymph nodes is needed. If the sentinel nodes are found to have no cancer then more extensive lymph nodal surgery can be avoided.Lymphoseek is used in patients with breast cancer, melanoma (a skin cancer) and a type of cancer of the mouth known as squamous cell carcinoma. It contains the active substance tilmanocept.

How is Lymphoseek used?

Lymphoseek is a solution that is injected either around or inside the cancerous tissue and and is expected to attach to and build up in the nearby lymph nodes. Before being injected into the patient, Lymphoseek is 'radiolabelled', which means that it is tagged with a small amount of radiation. A special camera that detects radiation is then used to see where the lymph nodes are and therefore where the cancer is likely to spread.Lymphoseek should only be used by healthcare professionals with expertise in mapping lymph nodes. The medicine can only be obtained with a prescription.

How does Lymphoseek work?

The active substance in Lymphoseek, tilmanocept, attaches to proteins called mannose binding proteins which are found in high amounts in certain immune cells in the lymph nodes. Because it attaches to these proteins, the radiolabelled medicine builds up in the lymph nodes surrounding the cancer, making them visible with the special camera. The lymph nodes can then be checked for cancer cells.

What benefits of Lymphoseek have been shown in studies?

The benefits of Lymphoseek were shown in two main studies in which 311 patients with breast or skin cancer had their lymph nodes first mapped with Lymphoseek and then with another method involving the use of a dye known as 'vital blue dye'. The blue dye is used during surgery to stain the lymph nodes so they can be seen and then checked for cancerous tissue. .In these two studies, doctors were able to detect a higher number of sentinel lymph nodes with Lymphoseek than with the blue dye: almost all of the lymph nodes identified using the blue dye (98% in one study and 100% in the other) were identified using Lymphoseek, while only around 70% and 60%, respectively, of the lymph nodes detected using Lymphoseek were detected with the blue dye.In a third study in patients with cancer of the head and neck including mouth cancer, Lymphoseek was used to detect sentinel lymph nodes before patients had their lymph nodes removed surgically. Almost all the patients (38 out of 39) with cancerous lymph nodes were identified by Lymphoseek.

What are the risks associated with Lymphoseek?

The most common side effects with Lymphoseek seen in clinical studies are pain and irritation at the injection site (seen in less than 1 patient in 100). Other side effects seen were uncommon, mild and short-lived. For the full list of all side effects and restrictions with Lymphoseek, see the package leaflet.

Why is Lymphoseek approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that studies showed that the use of Lymphoseek led to a higher detection rate for sentinel lymph nodes than the use of vital blue dye. Given the importance of locating lymph nodes in the treatment of cancers and the manageable side effects seen with Lymphoseek, the Committee concluded that its 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 Lymphoseek?

A risk management plan has been developed to ensure that Lymphoseek 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 Lymphoseek, including the appropriate precautions to be followed by healthcare professionals and patients.Further information can be found in the summary of the risk management plan.

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Lynparza

What is Lynparza and what is it used for?

Lynparza is a cancer medicine used for:• continuing treatment after initial treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb), and the peritoneum (membrane lining the abdomen) in:---• treatment of HER2-negative breast cancer (when the cancer cells do not have high levels of a protein called HER2) in patients with BRCA1 or BRCA2 mutations when the cancer:(early breast cancer), but there is a high risk of the cancer coming back;-• continuing treatment of pancreatic cancer in patients with mutations in BRCA1 or BRCA2 genes that is metastatic (has spread to other parts of the body) and has not worsened after at least 4 months of platinum-based chemotherapy;• treatment of metastatic prostate cancer in:--Lynparza contains the active substance olaparib. It is either used alone or in combination with other cancer medicines like bevacizumab in ovarian cancer, hormone therapy in breast cancer and abiraterone together with prednisone or prednisolone in prostate cancer.

How is Lynparza used?

Lynparza can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.Lynparza is available as tablets which the patient takes twice a day.The dose of Lynparza depends on what disease it is being used for. Treatment is continued for as long as the patient benefits from it and does not have unmanageable side effects. In advanced ovarian cancer, the doctor may stop treatment after 2 years if X-rays show no signs of the cancer. In early breast cancer, patients should be treated for up to 1 year. Treatment may be interrupted or stopped or the dose reduced if certain side effects develop.For more information about using Lynparza, see the package leaflet or contact your doctor or pharmacist.

How does Lynparza work?

The active substance in Lynparza, olaparib, blocks the action of an enzyme called human poly ADP ribose polymerase (PARP), which helps to repair damaged DNA in normal and cancer cells during cell division. Cancer cells with mutations such as the BRCA1 or BRCA2 mutations rely more heavily on PARP to repair their DNA and continue dividing. Therefore, when PARP is blocked, the damaged DNA in cancer cells cannot be repaired and, as a result, the cancer cells die.

What benefits of Lynparza have been shown in studies?

Ovarian cancerStudies show that Lynparza given on its own increases the time women with cancer of the ovary, fallopian tube or peritoneum live without their disease getting worse after treatment with platinumbased chemotherapy has shrunk or cleared the cancer:• A study involving 295 patients with relapsed cancer found that those receiving Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients receiving placebo (a dummy treatment).• In another study involving 265 patients with relapsed cancer, those who took Lynparza lived on average for 8.4 months without their disease getting worse compared with 4.8 months for patients on placebo.• In a third study involving 391 patients with advanced cancer who had BRCA1 or BRCA2 mutations, the disease did not get worse in around 74% of patients who took Lynparza for 2 years compared with 35% of patients on placebo.When given with bevacizumab, Lynparza increases the time patients with HRD-positive cancer live without their disease getting worse after treatment with platinum-based chemotherapy and bevacizumab has shrunk or cleared the cancer. In a main study of 806 patients with advanced highgrade ovarian, fallopian tube or peritoneal cancer, patients whose cancer was HRD-positive and who took Lynparza for 22 months lived on average 37.2 months without their disease getting worse compared with 17.7 months for those receiving placebo.Breast cancerLynparza was effective in a study involving 302 patients with HER2-negative breast cancer with BRCA1 or BRCA2 mutations whose cancer had spread. Patients treated with Lynparza lived on average 7.0 months without their disease getting worse compared with 4.2 months for patients treated with the doctor's choice of another cancer medicine.Another study involved 1,836 patients with BRCA1 or BRCA2 mutations and HER2-negative breast cancer which had not spread to other parts of the body after chemotherapy treatment given before or after surgery. The study showed that Lynparza was effective at preventing the disease from coming back when given alone or together with hormone therapy. Lynparza was given to 921 patients, a placebo was given to 916 patients, and all patients were allowed to have hormone therapy. After 3 years, the disease had worsened or spread in 12% of patients treated with Lynparza compared with 20% of patients taking placebo.Pancreatic cancerIn a study of 154 patients with BRCA1 or BRCA2 mutations who had metastatic pancreatic cancer that had not worsened during at least 4 months of treatment with platinum-based chemotherapy, Lynparza increased the time patients lived without their disease getting worse: those receiving Lynparza lived on average 7.4 months without their disease getting worse compared with 3.8 months for patients receiving placebo.Prostate cancerIn a study of 387 men with metastatic castration-resistant prostate cancer whose cancer had worsened during treatment with another cancer medicine, Lynparza on its own was effective in patients with BRCA1 or BRCA2 mutations (160 patients overall): patients with these mutations and treated with Lynparza lived on average 9.8 months without their disease getting worse, compared with 3.0 months in those treated with the doctor's choice of another cancer medicine.In a study of 796 men with metastatic and castration-resistant prostate cancer, Lynparza in combination with abiraterone and prednisone or prednisolone (hormone therapy) increased the time patients lived without their disease getting worse: those receiving Lynparza and hormone therapy lived on average 24.8 months without their disease getting worse, compared with 16.6 months in those treated with placebo (a dummy treatment) and hormone therapy.

What are the risks associated with Lynparza?

The most common side effects with Lynparza (which may affect more than 1 in 10 people) are nausea (feeling sick), tiredness, anaemia (low levels of red blood cells), vomiting, diarrhoea, decreased appetite, headache, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), dysgeusia (taste disturbances), cough, leucopenia (low levels of white blood cells), dizziness, dyspnoea (difficulty breathing) and dyspepsia (heartburn).The most common severe side effects (which may affect more than 2 in 100 people) are anaemia, neutropenia, tiredness, leucopenia and thrombocytopenia (low levels of blood platelets).Women must not breastfeed during treatment with Lynparza and for a month after stopping treatment.For the full list of side effects and restrictions with Lynparza, see the package leaflet.

Why is Lynparza authorised in the EU?

Generally, the outcome is poor for patients with ovarian, fallopian tube, or peritoneal cancer and for patients with HER2-negative breast cancer, pancreatic cancer with BRCA mutations or castrationresistant prostate cancer with or without BRCA mutations whose cancer has spread. Lynparza can increase the time these patients live without their disease getting worse. In ovarian, fallopian tube or peritoneal cancer, Lynparza can also delay the need for the next cycle of platinum chemotherapy.The side effects with Lynparza are mostly mild or moderate and are generally manageable. The European Medicines Agency therefore decided that Lynparza'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 Lynparza?

The company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit, of the medicine in patients with ovarian cancer and prostate cancer.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lynparza have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lynparza are continuously monitored. Side effects reported with Lynparza are carefully evaluated and any necessary action taken to protect patients.

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Lyrica

What is Lyrica?

Lyrica is a medicine that contains the active substance pregabalin. It is available as capsules (white: 25, 50 and 150 mg; white and orange: 75, 225 and 300 mg; orange: 100 mg; light orange: 200 mg) and as an oral solution (20 mg/ml).

What is Lyrica used for?

Lyrica is used to treat adults with the following conditions:• neuropathic pain (pain due to nerve damage). Lyrica can be used in peripheral neuropathic pain, such as the pain experienced by diabetic patients or by patients who have had herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;• epilepsy. Lyrica is used as an 'add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).The medicine can only be obtained with a prescription.

How is Lyrica used?

The recommended starting dose of Lyrica is 150 mg per day, divided into two or three doses. After three to seven days, the dose can be increased to 300 mg per day. Doses can be increased up to twice more until the most effective dose is reached. The maximum dose is 600 mg per day. Stopping treatment with Lyrica should also be done gradually, over at least a week.The capsules should be swallowed whole with water. Patients who have kidney problems need to take lower doses.

How does Lyrica work?

The active substance in Lyrica, pregabalin, is similar in structure to the body's own 'neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells. This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.

How has Lyrica been studied?

Lyrica has been compared with placebo (a dummy treatment) in 22 studies:• for peripheral neuropathic pain, there were ten studies involving over 3,000 patients, about half of whom had diabetic neuropathy and half of whom had pain following shingles. A further study was carried out in 137 patients with central neuropathic pain due to a spinal cord injury. The studies lasted up to 12 weeks. The effectiveness of Lyrica was measured using a standard pain questionnaire;• for epilepsy, there were three studies involving over 1,000 patients. The main measure of effectiveness was the change in the number of seizures after 11 to 12 weeks;• for generalised anxiety disorder, there were eight studies involving over 3,000 patients.Effectiveness was measured using a standard anxiety questionnaire after four to eight weeks.

What benefit has Lyrica shown during the studies?

In neuropathic pain, Lyrica was more effective than placebo in decreasing pain. In peripheral neuropathic pain, 35% of the patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo. In central neuropathic pain, 22% of patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.In epilepsy, Lyrica reduced the number of seizures: about 45% of the patients taking 600 mg Lyrica a day and about 35% of those taking 300 mg Lyrica a day had a reduction in seizures of 50% or more. This compared with about 10% of the patients taking placebo.In generalised anxiety disorder, Lyrica was more effective than placebo: 52% of the patients taking Lyrica had an improvement of 50% or more, compared with 38% of the patients taking placebo.TLyrica

What is the risk associated with Lyrica?

The most common side effects with Lyrica (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness). For the full list of all side effects reported with Lyrica, see the Package Leaflet.Lyrica should not be used in people who may be hypersensitive (allergic) to pregabalin or any of the other ingredients.

Why has Lyrica been approved?

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

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Lysakare

What is LysaKare and what is it used for?

LysaKare is a medicine used to protect the kidneys from radiation damage during cancer treatment with a radioactive medicine called lutetium (177Lu) oxodotreotide.LysaKare is for use in adults and contains the active substances arginine and lysine.

How is LysaKare used?

LysaKare is given by infusion (drip) in to a vein over 4 hours. Infusion with LysaKare is started 30 minutes before the patient is given lutetium (177Lu) oxodotreotide (also by infusion).Because LysaKare can cause nausea (feeling sick) and vomiting, patients will be given medicines to prevent nausea and vomiting before receiving LysaKare.LysaKare can only be obtained with a prescription and should only be given by a healthcare professional experienced in the use of radioactive medicines. For more information about using LysaKare, see the package leaflet or contact your doctor or pharmacist.

How does LysaKare work?

Radiation from lutetium (177Lu) oxodotreotide can cause damage when the medicine passes through tubules in the kidney. The active substances in LysaKare, arginine and lysine, interfere with the passage of lutetium (177Lu) oxodotreotide through these kidney tubules. As a result, the radioactive medicine leaves the body in the urine and the kidneys are exposed to less radiation.

What benefits of LysaKare have been shown in studies?

Because the use of arginine and lysine to protect the kidneys during this type of cancer treatment is well established, the company presented data from the scientific literature. These included data from over 1,200 cancer patients treated with lutetium (177Lu) oxodotreotide, which showed that arginine and lysine were effective at preventing kidney damage.In another published study involving 229 patients, measurement of creatinine clearance (an indication of how well the kidneys are working) did not show kidney damage 14 months after patients were treated with arginine and lysine at the same time as lutetium (177Lu) oxodotreotide.

What are the risks associated with LysaKare?

The most common side effects with LysaKare (which may affect more than 1 in 10 people) are nausea and vomiting. LysaKare is also associated with hyperkalaemia (high blood potassium levels), but the frequency of this side effect is not known. Side effects with LysaKare are usually mild or moderate.LysaKare must not be given to patients with high levels of potassium in the blood if this has not been corrected before treatment.For the full list of side effects and restrictions with LysaKare, see the package leaflet.

Why is LysaKare authorised in the EU?

The use of arginine and lysine during treatment with lutetium (177Lu) oxodotreotide has been shown to reduce kidney damage and allow patients to be given an effective dose of radioactive treatment for their cancer. The main risk with LysaKare is a dangerous rise of blood potassium levels but this side effect can be managed if recognised and treated appropriately. Information on how to do this has been included in the product information. The European Medicines Agency therefore decided that LysaKare'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 LysaKare?

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

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Lysodren

What is Lysodren?

Lysodren is a medicine that contains the active substance mitotane. It is available as tablets (500 mg).

What is Lysodren used for?

Lysodren is used to treat the symptoms of advanced adrenal cortical carcinoma (cancer of the outer layer of the adrenal gland). It is used when the cancer is unresectable (cannot be removed by surgery), is metastatic (has spread to other parts of the body), or has relapsed (returned after treatment).Because the number of patients with adrenal cortical carcinoma is low, the disease is considered 'rare', and Lysodren was designated an 'orphan medicine' (a medicine used in rare diseases) on 12 June 2002.The medicine can only be obtained with a prescription.

How is Lysodren used?

Treatment with Lysodren should be started and followed by a specialist who has suitable experience. The recommended starting dose in adults is 2 to 3 g per day, divided into two or three doses, taken with meals containing fatty food. A starting dose of 4 to 6 g per day can be used in patients who need urgent control of Cushing's syndrome (a set of symptoms of adrenal gland cancer caused by high hormone levels). The dose is increased in a stepwise manner until it reaches an 'optimal' dose thatgives the best results without causing unacceptable side effects. The levels of the active substance in the blood should be monitored frequently, with the final target dose aiming to reach blood levels between 14 and 20 mg per litre. This is usually reached within three to five months. Levels above 20 mg/l may cause severe side effects without increasing the medicine's effectiveness.The dose may be reduced or treatment interrupted if the patient experiences side effects. Treatment should continue as long as there is a benefit. If there is no improvement in symptoms after three months of treatment at the optimal dose, treatment should be stopped.There is limited information on the use of Lysodren in children, but a daily starting dose of 1.5 to 3.5 g per square metre body surface area (calculated using the child's height and weight) is recommended.Lysodren is not recommended for use in patients with severe liver or kidney problems, and it should be used with caution in those with mild or moderate liver or kidney problems. It should also be used with caution in elderly patients, with frequent monitoring of blood levels.Patients who take Lysodren should receive the 'Lysodren patient card' that they should carry with them in case of emergency, to inform healthcare professionals (such as doctors and nurses) that they are taking the medicine.

How does Lysodren work?

The cortex of the adrenal gland produces steroid hormones. When this area develops cancer, levels of these hormones can increase, causing the symptoms of the disease. The active substance in Lysodren, mitotane, is thought to work by preventing cells in the adrenal gland from working properly, by damaging their mitochondria (the energy-producing components), reducing the production of some steroid hormones. It may also alter the breakdown of these hormones. Together, these effects reduce the levels of the hormones in the body, improving the symptoms of the disease.

How has Lysodren been studied?

Since the active substance in Lysodren, mitotane, is a well-established medicine that has been used in the treatment of adrenal cortical carcinoma in Europe since 1959, the company presented information from the published literature to support its application for Lysodren.It presented the results of 220 studies published since 1990 on the use of the medicine in unresectable, metastatic adrenal cortical carcinoma. The studies included over 500 adults and children, who were treated for various lengths of time with mitotane, either alone or in combination with other anticancer medicines. The main measures of effectiveness in the studies included survival time, the reduction in tumour size and the time spent free of the symptoms of the disease.

What benefit has Lysodren shown during the studies?

Overall, the studies suggested that Lysodren could provide a benefit in patients with advanced adrenal cortical carcinoma, by increasing survival times (by over five years in a few cases) and causing shrinkage or stabilisation of tumour size in 20 to 30% of patients. It also reduced the symptoms of the disease, particularly in patients whose cancer was producing high hormone levels. There was insufficient evidence to support its use as an add-on to other anticancer medicines. Limited information was available on the use of mitotane in children, but overall, the children remained disease free for an average of seven months when taking the medicine.

What is the risk associated with Lysodren?

The most common side effects with Lysodren (seen in more than 1 patient in 10) are increased blood levels of liver enzymes, cholesterol and triglycerides (a type of fat), leucopenia (low white blood cell counts), prolonged bleeding time, ataxia (difficulty co-ordinating movements), paraesthesia (abnormal sensations like pins and needles), vertigo (a spinning sensation), sleepiness, mucositis (inflammation of the mucous membranes, such as the lining of the mouth), vomiting, diarrhoea, nausea (feeling sick), epigastric discomfort (discomfort around the stomach), skin rash, myasthenia (muscle weakness), adrenal insufficiency (reduced adrenal gland activity), loss of appetite, asthenia (weakness), gynaecomastia (breast enlargement) and confusion. For the full list of all side effects reported with Lysodren, see the package leaflet.Lysodren must not be used in people who are hypersensitive (allergic) to mitotane or any of the other ingredients. It must not be used in patients who are breast-feeding or who are taking spironolactone (a diuretic).

Why has Lysodren been approved?

The CHMP decided that Lysodren's benefits are greater than its risks for the treatment of advanced adrenal cortical carcinoma, but noted that the effect of Lysodren has not been established in adrenal cortical carcinoma that is not producing high levels of steroid hormones. The Committee recommended that Lysodren be given marketing authorisation.

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Lytgobi

What is Lytgobi and what is it used for?

Lytgobi is a cancer medicine used to treat adults with cholangiocarcinoma (biliary tract cancer or cancer of the bile ducts) when the cancer cells have an abnormal form of a receptor (target) called FGFR2 on their surface. Lytgobi is used when the cancer has spread to other parts of the body or cannot be removed by surgery and has worsened after previous treatment with at least one cancer medicine.Lytgobi contains the active substance futibatinib.

How is Lytgobi used?

Lytgobi can only be obtained with a prescription and treatment must be started by a doctor experienced in the diagnosis and treatment of the disease. The medicine is available as tablets, to be taken by mouth once a day. Treatment can continue for as long as the patient benefits from it and side effects are manageable.For more information about using Lytgobi, see the package leaflet or contact your doctor or pharmacist.

How does Lytgobi work?

This medicine is a tyrosine kinase inhibitor, meaning that it blocks the activity of enzymes known as tyrosine kinases. The active substance in Lytgobi, futibatinib, blocks receptors (targets) called fibroblast growth factor receptors (FGFRs), which are found on the surface of cells and help regulate cell growth. Cancer cells with changes in the FGFR gene have an abnormal form of this protein which makes them grow uncontrollably. By blocking FGFRs, futibatinib can prevent the growth of such cancer cells.

What benefits of Lytgobi have been shown in studies?

Lytgobi was investigated in a main study involving 103 adults with cholangiocarcinoma that had spread or that could not be removed with surgery, and who had previously received at least one systemictreatment. All patients had alterations (changes) in the FGFR2 gene. All patients in the study were given Lytgobi.When patients were given Lytgobi, the tumour size decreased in 42% (43 out of 103) of them and the response was maintained for almost 10 months on average.

What are the risks associated with Lytgobi?

For the full list of side effects and restrictions with Lytgobi, see the package leaflet.The most common side effects with Lytgobi (which may affect more than 1 in 5 people) include hyperphosphataemia (high levels of phosphates in the blood), nail disorders (such as nails separating from the nail bed, poor formation of the nail or change in colour of the nails), constipation, hair loss, diarrhoea, dry mouth, tiredness, nausea (feeling sick), dry skin, increased levels of liver enzymes in the blood, abdominal (belly) pain, stomatitis (inflammation of the lining of the mouth), vomiting, handfoot syndrome (a reaction to therapy causing redness, swelling, peeling or tenderness, mainly on the hands or feet), arthralgia (joint pain), and decreased appetite.The most common serious side effects with Lytgobi (which may affect more than 1 in 100 people), include intestinal obstruction and migraine.

Why is Lytgobi authorised in the EU?

At the time of approval, treatment options were limited for patients with locally advanced or metastatic cholangiocarcinoma who had previously received systemic therapy and who had FGFR2 alterations. Treatment with Lytgobi resulted in a durable response in about 40% of these patients that was maintained for almost 10 months on average, with side effects that could be managed with other medicines or dose adjustments. The medicine has been given 'conditional authorisation'. This means that the European Medicines Agency decided that the benefits of Lytgobi are greater than its risks, but the company will have to provide additional evidence after authorisation.Conditional authorisation is granted on the basis of less comprehensive data than are normally required. It is granted for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. Every year, the European Medicines Agency will review any new information that becomes available until data become comprehensive and this overview will be updated as necessary.Since Lytgobi was given conditional authorisation, at the time of authorisation the company marketing Lytgobi was required to provide data from an ongoing study on the effectiveness and safety of the medicine.

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

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

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Lyumjev

What is Lyumjev and what is it used for?

Lyumjev is a medicine used to control blood glucose (sugar) levels in adults and children aged 1 year and above with diabetes. It contains the active substance insulin lispro.

How is Lyumjev used?

Lyumjev can only be obtained with a prescription. It is given as an injection under the skin of the upper arm, thigh, buttock or belly. It can also be given with an insulin pump. A healthcare professional should explain to the patient how to use the medicine properly.Because Lyumjev is a fast-acting insulin, it is usually given just before a meal or, if more appropriate, soon after a meal. The dose of Lyumjev is worked out for each patient and depends on the patient's blood glucose level.In some circumstances, such as when blood acid levels are dangerously high (ketoacidosis), Lyumjev may be given into a vein, under a doctor's supervision.For more information about using Lyumjev, see the package leaflet or contact your doctor or pharmacist.

How does Lyumjev work?

In diabetes, patients have high levels of blood glucose either because the body does not produce enough insulin, or the body is unable to use insulin effectively.The active substance in Lyumjev is a form of insulin that acts faster than regular human insulin or standard insulin lispro medicines because it is absorbed more quickly by the body. It helps control blood glucose levels, thereby alleviating symptoms and reducing the risk of complications of diabetes.What benefits of Lyumjev have been shown in studiesLyumjev has been shown to be as good at controlling blood glucose as another insulin lispro medicine, Humalog, in four main studies.Two of the studies involved adults whose diabetes treatment already required injection of mealtime insulin, one involving 1,222 patients with type 1 diabetes (where the body cannot make its own insulin) and one in 673 patients with type 2 diabetes (where the body cannot make enough insulin or cannot use it effectively). The main measure of effectiveness was the HbA1c percentage: lower HbA1c marks well-controlled blood glucose. The average starting HbA1c in both studies was 7.3%. Over 6 months of treatment, patients with type 1 diabetes experienced a fall of 0.13 percentage points in HbA1c with Lyumjev and 0.05 percentage points with Humalog. In patients with type 2 disease, HbA1c fell by 0.38 percentage points with Lyumjev and 0.43 percentage points with Humalog.The third, smaller, study involved 49 adults whose diabetes was managed with an insulin pump and indicated that both Lyumjev and Humalog were effective in maintaining control of blood sugar in this setting.A fourth study involving 716 children aged 3 years and above with type 1 diabetes also showed that Lyumjev was at least as effective as Humalog in maintaining control of blood sugar.

What are the risks associated with Lyumjev?

The most common side effect with Lyumjev (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).Lyumjev must not be given to people whose blood glucose level is already low. Doses may need to be adjusted when it is given with other medicines that reduce blood glucose.For the full list of side effects and restrictions of Lyumjev, see the package leaflet.

Why is Lyumjev authorised in the EU?

Lyumjev has been shown to be effective in controlling blood sugar, and because its action begins faster than existing insulin lispro medicines it was particularly useful in reducing the rise in blood glucose after a meal, although side effects such as low blood sugar might also develop more quickly.The main studies looked at adults with type 1 and type 2 diabetes as well as children from 3 years of age with type 1 diabetes. The European Medicines Agency noted that these studies were sufficient to show that the medicine will be effective in younger children (from 1 year of age) with type 1 or type 2 diabetes.The Agency therefore decided that Lyumjev'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 Lyumjev?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lyumjev have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Lyumjev are continuously monitored. Side effects reported with Lyumjev are carefully evaluated and any necessary action taken to protect patients.Lyumjev0F (insulin lispro)

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Lyxumia

What is Lyxumia?

Lyxumia is a diabetes medicine that contains the active substance lixisenatide. It is available as a solution for injection in a pre-filled pen that provides either 10 micrograms or 20 micrograms of lixisenatide in each dose.

What is Lyxumia used for?

Lyxumia is used in adults who have type 2 diabetes to control their blood glucose (sugar) level. It is used together with diabetes medicines taken by mouth and/or basal insulin (long-acting insulin) in patients whose blood glucose levels are not adequately controlled by these medicines together with diet and exercise.The medicine can only be obtained with a prescription.

How is Lyxumia used?

Lyxumia is injected once a day, in the hour before the same meal every day. It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh. Lyxumia is started at a dose of 10 micrograms once a day which is increased to 20 micrograms once a day after 14 days.If the patient is already taking a sulphonylurea (another diabetes medicine) or basal insulin, the doctor may need to reduce the dose of the sulphonylurea or basal insulin because there is a risk of hypoglycaemia (low blood sugar levels). Adding Lyxumia to metformin is not associated with this risk. Lyxumia should not be given with a combination of both, basal insulin and a sulphonylurea.

How does Lyxumia work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Lyxumia, lixisenatide, is a 'GLP-1 receptor agonist'. It works by attaching to glucagon-like peptide 1 (GLP-1) receptors that are found on the surface of the cells in the pancreas and that cause the production of insulin by the pancreas. When Lyxumia is injected, lixisenatide reaches the receptors in the pancreas and activates them. This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.

How has Lyxumia been studied?

Lyxumia has been studied in seven main studies involving 3,825 adults with type 2 diabetes. Six of the studies compared Lyxumia with placebo (a dummy treatment), used alone or when added to metformin, a sulphonylurea, basal insulin, or a combination of two of these medicines, in patients in whom previous treatment had failed. In one study, Lyxumia was compared with another diabetes medicine called exenatide when added to metformin in patients whose blood sugar levels were not adequately controlled by metformin.All of the studies measured the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached. HbA1c gives an indication of how well the blood glucose is controlled. HbA1c levels were measured after 12 weeks when Lyxumia was used alone and after 24 weeks when it was used in combination with other diabetes medicines.

What benefit has Lyxumia shown during the studies?

Lyxumia was more effective than placebo at controlling blood glucose. When used on its own, Lyxumia reduced Hb1Ac levels by 0.6% more than placebo. When used in combination with other diabetes medicines, Lyxumia reduced Hb1Ac levels by 0.4 up to 0.9% more than placebo.The study comparing Lyxumia with exenatide (added to metformin) showed reduced HbA1c levels by 0.79% after 24 weeks treatment with Lyxumia compared to 0.96% with exenatide twice daily.

What is the risk associated with Lyxumia?

The most common side effects with Lyxumia (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea and headache. These side effects were mostly mild and usually resolved over time. When used together with a sulphonylurea or basal insulin, the most common side effect (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). Allergic reactions have been reported in less than 1 in 100 patients using Lyxumia.For the full list of all side effects and restrictions with Lyxumia, see the package leaflet.

Why has Lyxumia been approved?

The CHMP concluded that Lyxumia was shown to be effective at lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines. In addition, beneficial weight loss was seen in patients treated with Lyxumia. Regarding its safety, most side effects are comparable to those of other similar diabetes medicines with side effects affecting the gut being the most common ones. The CHMP concluded that the benefits of Lyxumia outweigh its risks and recommended that it be granted marketing authorisation.

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

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

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