Pomalidomide Accord 4 mg hard capsules EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Pomalidomida Accord 1 mg hard capsules

Pomalidomida Accord 2 mg hard capsules

Pomalidomida Accord 3 mg hard capsules

Pomalidomida Accord 4 mg hard capsules

pomalidomide

Pomalidomide Accord is expected to cause severe birth defects and may result in fetal death.

• Do not take this medicine if you are pregnant or may be pregnant.
• You must follow the contraceptive measures described in this leaflet.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Pomalidomida Accord is and what it is used for
2. What you need to know before taking Pomalidomida Accord
3. How to take Pomalidomida Accord
4. Possible side effects
5. How to store Pomalidomida Accord
6. Contents of the pack and other information

1. What Pomalidomide Accord is and what it is used for

What Pomalidomide Accord is

Pomalidomide Accord contains the active substance "pomalidomide". This medicine is related to thalidomide and belongs to a group of medicines that affect the immune system (the body's natural defences).

What Pomalidomide Accord is used for

Pomalidomide Accord is used to treat adults with a type of cancer called "multiple myeloma".

Pomalidomide Accord is used in combination with:

• Two other medicines called "bortezomib" (a type of chemotherapy medicine) and "dexamethasone" (an anti-inflammatory medicine) in people who have received at least one prior treatment, including lenalidomide.

Or

• One other medicine called "dexamethasone" in people whose myeloma has worsened despite having received at least two prior treatments, including the medicines lenalidomide and bortezomib.

What multiple myeloma is

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called "plasma cells"). These cells grow uncontrollably and accumulate in the bone marrow, damaging bones and kidneys.

Multiple myeloma is generally incurable. However, treatment can reduce or eliminate the signs and symptoms of the disease for a period of time. When this occurs, it is referred to as a "response".

How Pomalidomide Accord works

Pomalidomide Accord works in several ways:

• It stops the growth of myeloma cells;
• It stimulates the immune system to attack cancer cells;
• It inhibits the formation of blood vessels that supply cancer cells.

Benefit of using Pomalidomide Accord with bortezomib and dexamethasone

When Pomalidomide Accord is used in combination with bortezomib and dexamethasone in people who have received at least one prior treatment, it can delay the progression of multiple myeloma:

• Typically, the combination of Pomalidomide Accord with bortezomib and dexamethasone delayed the return of multiple myeloma for up to 11 months, compared with 7 months in patients receiving only bortezomib and dexamethasone.

Benefit of using Pomalidomide Accord with dexamethasone

When Pomalidomide Accord is used with dexamethasone in people who have received at least two prior treatments, it can delay the progression of multiple myeloma:

• Typically, the combination of Pomalidomide Accord and dexamethasone delayed the return of multiple myeloma for up to 4 months, compared with 2 months in patients receiving dexamethasone alone.

2. What you need to know before taking Pomalidomida Accord

Do not take Pomalidomida Accord:

• if you are pregnant, think you might be pregnant, or intend to become pregnant, as Pomalidomida Accord is expected to be harmful to the fetus. (Men and women taking this medicine should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below);
• if you could become pregnant, unless you are taking all necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If you could become pregnant, your doctor will confirm with each prescription that all necessary precautions have been taken and will provide you with this confirmation;
• if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

If you are unsure whether any of the situations described above apply to you, consult your doctor, pharmacist, or nurse before taking Pomalidomida Accord.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pomalidomida Accord if:

• you have ever had blood clots in the past. During treatment with Pomalidomida Accord, you have an increased risk of developing blood clots in your veins or arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reducing your dose of Pomalidomida Accord to lower the risk of blood clots;
• you have previously experienced an allergic reaction, such as rash, itching, swelling, dizziness, or breathing difficulties while taking related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have difficulty breathing, or, if you are a smoker, have high blood pressure or high cholesterol levels;
• you have a high total tumor burden in the body, including in the bone marrow. This may lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure. You may also experience irregular heartbeats. This condition is called tumor lysis syndrome;
• you suffer from or have previously had neuropathy (nerve damage causing tingling or pain in your hands or feet);
• you have or have previously had hepatitis B virus infection. Treatment with Pomalidomida Accord may reactivate the hepatitis B virus in carriers, causing the infection to recur. Your doctor should check whether you have ever had hepatitis B virus infection;
• you are currently experiencing or have previously experienced a combination of any of the following symptoms: facial or widespread rash, skin redness, high fever, flu-like symptoms, enlarged lymph nodes (symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms, or DRESS syndrome, drug hypersensitivity syndrome, toxic epidermal necrolysis [TEN], or Stevens-Johnson syndrome [SJS]). See also section 4 “Possible side effects”).

It is important to note that patients with multiple myeloma treated with pomalidomide may develop other types of cancer, so your doctor must carefully evaluate the benefits and risks when prescribing this medicine.

At any time during or after treatment, inform your doctor or nurse immediately if you experience: blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk, balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially life-threatening brain disease known as progressive multifocal leukoencephalopathy (PML). If you had any of these symptoms before starting treatment with Pomalidomida Accord, inform your doctor if you notice any changes in these symptoms.

At the end of treatment, you must return all unused capsules to the pharmacist.

Pregnancy, contraception and breastfeeding: information for men and women

You must follow the instructions outlined in the Pomalidomida Accord Pregnancy Prevention Programme.

Men and women taking Pomalidomida Accord must not father a child or become pregnant. This is because pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive methods while taking this medicine.

Women

Do not take Pomalidomida Accord if you are pregnant, think you might be pregnant, or intend to become pregnant. This is because this medicine is expected to be harmful to the fetus. Before starting treatment, you must inform your doctor if there is any possibility you could become pregnant, even if you consider this unlikely.

If you could become pregnant:

• you must use effective contraception starting at least 4 weeks before beginning treatment, throughout the entire treatment period, and for at least 4 weeks after stopping treatment. Your doctor will advise you on the most appropriate contraceptive methods;
• each time your doctor prescribes a new prescription, they will ensure you understand the necessary measures to prevent pregnancy;
• your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and inform your doctor immediately.

Breastfeeding

It is unknown whether Pomalidomida Accord passes into human breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether you should continue or stop breastfeeding.

Men

Pomalidomida Accord passes into human semen.

• If your partner is pregnant or could become pregnant, you must use condoms throughout the entire treatment period and for 7 days after stopping treatment.
• If your partner becomes pregnant while you are taking Pomalidomida Accord, inform your doctor immediately. Your partner must also inform her doctor immediately.

You must not donate semen or sperm during treatment and for 7 days after stopping treatment.

Blood donation and blood tests

You must not donate blood during treatment and for 7 days after stopping treatment.

Before starting treatment with Pomalidomida Accord and during treatment, you will have periodic blood tests. This is because your medicine may cause a decrease in the number of blood cells that help fight infections (white blood cells) and in the number of cells that help stop bleeding (platelets).

Your doctor will request that you have blood tests:

• before starting treatment;
• weekly during the first 8 weeks of treatment;
• at least once a month while continuing to take Pomalidomida Accord.

Your doctor may adjust the dose of Pomalidomida Accord or interrupt your treatment based on the results of these tests. Your doctor may also adjust the dose or discontinue this medicine based on your overall health status.

Children and adolescents

Pomalidomida Accord is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Pomalidomida Accord

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because Pomalidomida Accord may affect how other medicines work. In addition, some medicines may affect how Pomalidomida Accord works.

In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomida Accord if you are taking any of the following medicines:

• certain antifungals such as ketoconazole;
• certain antibiotics (e.g., ciprofloxacin, enoxacin);
• certain antidepressants such as fluvoxamine.

Driving and using machines

Some people experience fatigue, fainting, confusion, or reduced alertness while taking Pomalidomida Accord. If this happens to you, do not drive or operate tools or machinery.

Pomalidomida Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free”.

3. How to take Pomalidomide Accord

Pomalidomide Accord must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.

Always follow exactly the instructions for use provided by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.

When to take Pomalidomide Accord with other medicines

Pomalidomide Accord in combination with bortezomib and dexamethasone

• Refer to the package leaflet accompanying bortezomib and dexamethasone for additional information on their use and effects.

• Pomalidomide Accord, bortezomib, and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).

• Follow the schedule below to see which medicines you should take each day of the 3-week cycle:

• Each day, check the schedule and identify the correct day to see which medicines you should take.

• On some days you will take all three medicines, on other days only one or two medicines, and on some days none of them.

• POM: Pomalidomide Accord; BOR: bortezomib; DEX: dexamethasone

Cycles 1 to 8				Cycle 9 onwards
	Drug name				Drug name
Day	POM	BOR	DEX			Day	POM	BOR	DEX
1	√	√	√			1	√	√	√
2	√		√			2	√		√
3	√					3	√
4	√	√	√			4	√
5	√		√			5	√
6	√					6	√
7	√					7	√
8	√	√	√			8	√	√	√
9	√		√			9	√		√
10	√					10	√
11	√	√	√			11	√
12	√		√			12	√
13	√					13	√
14	√					14	√
15						15
16						16
17						17
18						18
19						19
20						20
21						21

• After completing each 3-week cycle, start a new one.

Pomalidomida Accord with dexamethasone only

Refer to the package leaflet provided with dexamethasone for additional information on its use and effects.

• Pomalidomida Accord and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).

• See the following chart to determine which medication(s) to take each day of the 4-week cycle:

• Each day, consult the chart and identify the correct day to see which medications you should take.

• On some days you will take both medications, on other days only one medication, and on some days neither medication.

• POM: Pomalidomida Accord; DEX: dexamethasone

	Name of the medication
Day	POM	DEX
1	√	√
2	√
3	√
4	√
5	√
6	√
7	√
8	√	√
9	√
10	√
11	√
12	√
13	√
14	√
15	√	√
16	√
17	√
18	√
19	√
20	√
21	√
22		√
23
24
25
26
27
28

• After completing each 4-week cycle, start a new one.

Pomalidomide Accord dosage with other medicines

Pomalidomide Accord with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Accord is 4 mg once daily.
• The recommended starting dose of bortezomib will be calculated by your doctor based on your height and weight (1.3 mg/m² body surface area).
• The recommended starting dose of dexamethasone is 20 mg once daily. However, if you are over 75 years of age, the recommended starting dose is 10 mg once daily.

Pomalidomide Accord with dexamethasone only

• The recommended dose of Pomalidomide Accord is 4 mg once daily.

The recommended starting dose of dexamethasone is 40 mg once daily. However, if you are over 75 years of age, the recommended starting dose is 20 mg once daily.

Your doctor may need to reduce the dose of Pomalidomide Accord, bortezomib, or dexamethasone, or interrupt one or more of these medicines, depending on your blood test results and general condition, whether you are taking other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and whether you experience adverse effects (especially rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will carefully monitor your condition while you are receiving this medicine.

How to take Pomalidomide Accord

• Do not break, open, or chew the capsules. If the powder from a broken capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Afterwards, gloves should be carefully removed to avoid skin exposure, placed into a sealed polyethylene plastic bag, and disposed of according to local requirements. Hands should then be thoroughly washed with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• You may take the capsules with or without food.
• You should take Pomalidomide Accord at approximately the same time each day.

To remove the capsule from the blister, press only on one end of the capsule so that it comes through the foil. Do not press in the middle of the capsule, as this may break it.

Your doctor will advise you on how and when to take Pomalidomide Accord if you have kidney problems and are undergoing dialysis treatment.

Duration of treatment with Pomalidomide Accord

You should continue the treatment cycles until your doctor tells you to stop.

If you take more Pomalidomide Accord than you should

If you take more Pomalidomide Accord than you should, inform your doctor or go to hospital immediately. Take the medicine container with you.

If you forget to take Pomalidomide Accord

If you forget to take Pomalidomide Accord on the day you were supposed to, take the next capsule the following day at your usual time. Do not take extra capsules to make up for the missed dose of Pomalidomide Accord.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

If you experience any of the following serious adverse effects, stop treatment with Pomalidomide Accord and see a doctor immediately, as you may require urgent medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to reduced white blood cells that fight infection).
• Bleeding or bruising without apparent cause, including nosebleeds and intestinal or stomach bleeding (due to effects on blood cells called "platelets").
• Rapid breathing, rapid pulse, fever and chills, little or no urination, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhoea (possibly accompanied by stomach pain or fever) caused by the bacterium Clostridium difficile.
• Chest or leg pain and swelling, especially in the lower leg or calves (caused by blood clots).
• Difficulty breathing (due to a severe chest infection, lung inflammation, heart failure, or blood clots).
• Swelling of the face, lips, tongue, and throat, which may cause difficulty breathing (due to severe allergic reactions known as angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the appearance of the skin or lumps on the skin. If you notice any skin changes while taking Pomalidomide Accord, inform your doctor as soon as possible.
• Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea, or malaise. Inform your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomide if you develop these symptoms and contact your doctor or seek immediate medical attention. See also section 2.
• If you experience any of the following serious adverse effects, stop treatment with Pomalidomide Accord and see a doctor immediately, as you may require urgent medical treatment.

Other adverse effects

Very common (may affect more than 1 in 10 people):

• Difficulty breathing (dyspnoea).

• Lung infection (pneumonia and bronchitis).

• Infections of the nose, sinuses, and throat caused by bacteria or viruses.

• Flu-like symptoms (influenza).

• Low red blood cell count, which may lead to anaemia causing tiredness and weakness.

• Low blood potassium levels (hypokalaemia), which may cause weakness, muscle cramps and pain, palpitations, tingling or numbness, dyspnoea, and mood changes.

• High blood sugar levels.

• Fast and irregular heartbeat (atrial fibrillation).

• Loss of appetite.

• Constipation, diarrhoea, or nausea.

• Vomiting.

• Abdominal pain.

• Lack of energy.

• Difficulty falling or staying asleep.

• Dizziness, tremor.

• Muscle spasms, muscle weakness.

• Bone pain, back pain.

• Numbness, tingling, or burning sensation in the skin, pain in hands or feet (peripheral sensory neuropathy).

• Generalised swelling, including swelling of arms and legs.

• Skin rashes.

• Urinary tract infection, which may cause a burning sensation when urinating or increased need to urinate.

Common (may affect up to 1 in 10 people):

• Fall.
• Bleeding inside the skull.
• Reduced ability to move or feel (sensation) in the hands, feet, and legs due to neurological damage (peripheral sensory-motor neuropathy).
• Numbness, itching, or tingling in the skin (paraesthesia).
• Sensation of dizziness or spinning, making it difficult to stand and move normally.
• Swelling due to fluid retention.
• Hives (urticaria).
• Itching of the skin.
• Shingles (herpes zoster).
• Heart attack (chest pain spreading to the arms, neck, and jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Reduction in the number of red blood cells, white blood cells, and platelets at the same time (pancytopenia), making you more prone to bleeding and bruising. You may feel tired and weak and have difficulty breathing. You will also be more susceptible to infections.
• Decreased number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia).
• Low blood magnesium levels (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, and irritability, and may lead to low blood calcium levels (hypocalcaemia), causing numbness or tingling in hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low blood phosphate levels (hypophosphataemia), which may cause muscle weakness, irritability, or confusion.
• High blood calcium levels (hypercalcaemia), which may slow reflexes and cause skeletal muscle weakness.
• High blood potassium levels, which may cause abnormal heart rhythm.
• Low blood sodium levels, which may cause tiredness and confusion, muscle twitching, seizures (epileptic fits), or coma.
• High blood uric acid levels, which may cause a type of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Mouth pain or dryness.
• Changes in taste.
• Swollen abdomen.
• Confusion.
• Feeling low in mood (depressed).
• Loss of consciousness, fainting.
• Cloudiness in the eye (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal results in liver function tests.
• Pelvic pain.
• Weight loss.

Uncommon (may affect up to 1 in 100 people):

• Stroke.
• Inflammation of the liver (hepatitis), which may cause itchy skin, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Breakdown of tumour cells resulting in the release of toxic substances into the bloodstream (tumour lysis syndrome). This may lead to kidney problems.
• Underactive thyroid gland, which may cause symptoms such as fatigue, sluggishness, muscle weakness, slow heart rate, and weight gain.

Frequency not known (cannot be estimated from available data):

• Rejection of solid organ transplants (such as heart or liver).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pomalidomide Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton following CAD/EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Do not use Pomalidomide Accord if you notice any visible signs of deterioration or evidence of improper handling of the medicine.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging when they are no longer needed. This helps protect the environment.

6. Contents of the pack and other information

Composition of Pomalidomide Accord

• The active substance is pomalidomide.
• The other components are microcrystalline cellulose, maltodextrin and sodium fumarate.

Pomalidomide Accord 1 mg hard capsule:

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171) and propylene glycol (E1520).

Pomalidomide Accord 2 mg hard capsule:

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171) and propylene glycol (E1520).

Pomalidomide Accord 3 mg hard capsule:

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172) and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171) and propylene glycol (E1520).

Pomalidomide Accord 4 mg hard capsule:

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigotine (E132) and erythrosine (E127).
• The printing ink contains: shellac, titanium dioxide (E171) and propylene glycol (E1520).

Appearance of Pomalidomide Accord and pack contents

Pomalidomide Accord 1 mg hard capsules: hard gelatin capsule, with yellow body and red cap, marked "PLM 1" in white ink on the body of the capsule.

Pomalidomide Accord 2 mg hard capsules: hard gelatin capsule, with orange body and red cap, marked "PLM 2" in white ink on the body of the capsule.

Pomalidomide Accord 3 mg hard capsules: hard gelatin capsule, with turquoise body and red cap, marked "PLM 3" in white ink on the body of the capsule.

Pomalidomide Accord 4 mg hard capsules: hard gelatin capsule, with dark blue body and red cap, marked "PLM 4" in white ink on the body of the capsule.

Pomalidomide Accord is available in blister packs of 7, 14 or 21 capsules or in perforated unit dose blisters of 7 x 1, 14 x 1 or 21 x 1 capsules. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6th Floor,

08039 Barcelona,

Spain

Manufacturer

Synthon Hispania S.L.

Castello, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat, Spain

Synthon B.V.

Microweg 22

6545 CM Nijmegen, The Netherlands

Accord Healthcare Polska Sp. z.o.o.

ul. Lutomierska 50,

95-200, Pabianice, Poland

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Tel: +30 210 74 88 821

Date of the latest revision of this leaflet: July 2024

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also provided.