Pomalidomide Stada

Leaflet attached to the packaging: patient information

Pomalidomide Stada, 1 mg, hard capsules

Pomalidomide Stada, 2 mg, hard capsules

Pomalidomide Stada, 3 mg, hard capsules

Pomalidomide Stada, 4 mg, hard capsules

Pomalidomide

It should be expected that Pomalidomide Stada will cause severe birth defects and may lead to fetal death.

• The medicine must not be taken if the patient is pregnant or may become pregnant.
• Patients must follow the contraceptive advice presented in this leaflet.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Pomalidomide Stada and what is it used for
• 2. Important information before taking Pomalidomide Stada
• 3. How to take Pomalidomide Stada
• 4. Possible side effects
• 5. How to store Pomalidomide Stada
• 6. Contents of the pack and other information

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

What is Pomalidomide Stada

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

What is Pomalidomide Stada used for

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

Pomalidomide Stada is used in combination with:

• two other medicines, bortezomib (a type of chemotherapy) and dexamethasone (an anti-inflammatory medicine) in patients who have already received at least one other type of treatment containing lenalidomide or
• one other medicine, dexamethasone in patients with myeloma that has worsened despite previously receiving at least two other types of treatment containing lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a cancer that attacks a type of white blood cell (called plasma cells). These cells grow uncontrollably and accumulate in the bone marrow, causing bone and kidney damage.

In principle, multiple myeloma is incurable. However, treatment can alleviate the symptoms of the disease or make them disappear for a while - this is called a "response" to treatment.

How does Pomalidomide Stada work

Pomalidomide Stada works in several ways:

• by inhibiting the growth of myeloma cells,
• by stimulating the immune system to attack cancer cells,
• by inhibiting the formation of blood vessels that feed cancer cells.

Benefits of using Pomalidomide Stada with bortezomib and dexamethasone

Pomalidomide Stada, when used in combination with bortezomib and dexamethasone in patients who have already received at least one other type of treatment, may slow down the progression of multiple myeloma.

• Pomalidomide used with bortezomib and dexamethasone usually delayed the relapse of multiple myeloma by 11 months - compared to 7 months in patients who received only bortezomib and dexamethasone.

Benefits of using Pomalidomide Stada with dexamethasone

Pomalidomide Stada, when used in combination with dexamethasone in patients who have already received at least two other types of treatment, may slow down the progression of multiple myeloma.

• Pomalidomide with dexamethasone usually delayed the relapse of multiple myeloma by 4 months - compared to 2 months in patients who received only dexamethasone.

2. Important information before taking Pomalidomide Stada

When not to take Pomalidomide Stada:

• if the patient is allergic to pomalidomide or any of the other ingredients of this medicine, listed in section 6. If an allergy to the medicine is suspected, consult a doctor for advice.
• if the patient is pregnant, suspects that she is pregnant, or plans to become pregnant, as it should be expected that Pomalidomide Stada will harm the fetus (men and women taking this medicine must read the section "Pregnancy, contraception, and breastfeeding - information for men and women" below).
• if the patient may become pregnant, unless all necessary measures to prevent pregnancy are used (see the section "Pregnancy, contraception, and breastfeeding - information for men and women"). If the patient may become pregnant, the doctor will always make a note when prescribing the medicine that the patient has understood all the necessary measures to prevent pregnancy that they must use and will provide the patient with this confirmation. If the patient is unsure whether any of the above situations apply to them, they should consult their doctor, pharmacist, or nurse before starting treatment with Pomalidomide Stada.

Warnings and precautions

Before starting treatment with Pomalidomide Stada, discuss with your doctor, pharmacist, or nurse if:

• the patient has ever had blood clots in the past. During treatment with Pomalidomide Stada, there is an increased risk of blood clots forming in veins and arteries. The doctor may prescribe additional treatment (e.g., warfarin) or reduce the dose of Pomalidomide Stada to reduce the risk of blood clots.

Pomalidomide Stada may increase the risk of developing additional types of cancer. Therefore, the doctor should carefully assess the benefits and risks associated with prescribing this medicine to the patient.

If any of the following symptoms occur during or after treatment, the patient should immediately inform their doctor or nurse:

• vision disturbances, loss of vision, or double vision,
• difficulty speaking, weakness in the arms or legs, changes in gait, or balance problems,
• numbness, decreased sensation, or loss of sensation,
• memory loss or disorientation.

All of the above symptoms may indicate a severe and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML).

Children and adolescents

Pomalidomide Stada is not recommended for use in children and adolescents under 18 years of age.

Pomalidomide Stada and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, as Pomalidomide Stada may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Stada.

Before taking Pomalidomide Stada, inform your doctor, pharmacist, or nurse, especially if you are taking any of the following medicines:

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

Pregnancy, contraception, and breastfeeding - information for men and women

As indicated below, during treatment with Pomalidomide Stada, pregnancy prevention programs must be followed.

Women taking Pomalidomide Stada must not become pregnant and men taking Pomalidomide Stada must not father a child. It should be expected that this medicine will harm the fetus. The patient and their partner should use effective contraception during treatment with this medicine.

Women

Pomalidomide Stada must not be taken if the patient is pregnant, suspects that she is pregnant, or plans to become pregnant, as it should be expected that this medicine will harm the fetus. Before starting treatment, the patient should tell their doctor if she can become pregnant, even if she thinks it is unlikely.

If the patient can become pregnant:

• she must use effective contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. The patient should discuss with her doctor which contraceptive method is best for her.
• each time the medicine is prescribed, the doctor will ensure that the patient has understood all the necessary measures to prevent pregnancy that she must use to prevent pregnancy.
• the doctor will order pregnancy tests before treatment, no less than every 4 weeks during treatment, and for at least 4 weeks after stopping treatment.
• If the patient becomes pregnant despite using preventive measures:
• she must stop treatment immediately and inform her doctor immediately.

Breastfeeding

It is not known whether Pomalidomide Stada passes into human milk. If the patient is breastfeeding or plans to breastfeed, she should tell her doctor. The doctor will inform the patient whether she should stop or continue breastfeeding.

Men

Pomalidomide Stada is present in human semen.

• If the patient's partner is pregnant or may become pregnant, the patient must use condoms during the entire treatment period and for 7 days after stopping treatment.
• If the patient's partner becomes pregnant during treatment with Pomalidomide Stada, the patient should immediately inform their doctor. The partner should immediately consult a doctor.

The patient should not donate sperm or semen during treatment and for 7 days after stopping treatment.

Blood donation and blood tests

During treatment and for 7 days after stopping treatment, the patient should not donate blood.

Before and during treatment with Pomalidomide Stada, the patient will undergo regular blood tests. This is because the medicine may cause a decrease in the number of blood cells (white blood cells) that help fight infections and a decrease in the number of cells (platelets) that help stop bleeding.

The doctor will order blood tests:

• before treatment,
• every week during the first 8 weeks of treatment,
• then at least once a month for as long as the patient takes Pomalidomide Stada.

The doctor may change the dose of Pomalidomide Stada or stop treatment based on the patient's blood test results or their overall health.

Driving and using machines

While taking Pomalidomide Stada, some people may feel tired, dizzy, faint, confused, or have reduced alertness. If these symptoms occur, the patient should not drive, use tools, or operate machinery.

Pomalidomide Stada contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicinal product is considered "sodium-free".

Pomalidomide Stada contains isomalt

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Pomalidomide Stada

Pomalidomide Stada must be administered by a doctor with experience in treating multiple myeloma.

This medicine should always be taken exactly as prescribed by the doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.

When to take Pomalidomide Stada with other medicines

Pomalidomide Stada with bortezomib and dexamethasone

• Read the leaflets for bortezomib and dexamethasone to get more information about their use and effects.
• Pomalidomide Stada, bortezomib, and dexamethasone are used in treatment cycles. Each cycle lasts 21 days (3 weeks).
• The following table shows which medicines to take on which days of the 3-week cycle:
• Each day, find the corresponding day on the table and check which medicines to take.
• On some days, take all 3 medicines, on some days take 2 medicines or 1 medicine, and on some days do not take any medicines.

POM:Pomalidomide (Pomalidomide Stada); BOR: bortezomib; DEX: dexamethasone

Cycles 1 to 8 Cycle 9 and subsequent

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

Pomalidomide Stada only with dexamethasone

• Read the leaflet for dexamethasone to get more information about its use and effects.
• Pomalidomide Stada and dexamethasone are used in treatment cycles. Each cycle lasts 28 days (4 weeks).
• The following table shows which medicines to take on which days of the 4-week cycle:
• Each day, find the corresponding day on the table and check which medicines to take.
• On some days, take both medicines, on some days take 1 medicine, and on some days do not take any medicines.

POM:Pomalidomide (Pomalidomide Stada); DEX: dexamethasone

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

What dose of Pomalidomide Stada to take with other medicines

Pomalidomide Stada with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Stada is 4 mg per day.
• The recommended starting dose of bortezomib will be determined by the doctor based on the patient's weight and body surface area (1.3 mg/m2).
• The recommended starting dose of dexamethasone is 20 mg per day. However, if the patient is over 75 years old, the recommended starting dose is 10 mg per day.

Pomalidomide Stada only with dexamethasone

• The recommended dose of Pomalidomide Stada is 4 mg per day.
• The recommended starting dose of dexamethasone is 40 mg per day. However, if the patient is over 75 years old, the recommended starting dose is 20 mg per day.

The doctor may reduce the dose of Pomalidomide Stada, bortezomib, or dexamethasone, or stop treatment with one or more of these medicines based on the patient's blood test results, their overall health, the use of other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if the patient experiences side effects due to treatment (especially rash and swelling).

If the patient has kidney or liver disease, the doctor will closely monitor their health while taking this medicine.

How to take Pomalidomide Stada

• Do not break, open, or chew the capsules. If the powder from a damaged Pomalidomide Stada capsule comes into contact with the skin, wash the skin immediately with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. Remove the gloves carefully to avoid skin exposure, place them in a sealed plastic bag, and dispose of them according to local regulations. Then, wash your hands with soap and water. Pregnant or potentially pregnant women should not touch the blister or capsule.
• Swallow the capsules whole, preferably with water.
• The capsules can be taken with or without food.
• Take Pomalidomide Stada at approximately the same time each day.

To remove a capsule from the blister, press only on one side and push the capsule through the foil. Do not press on the center of the capsule, as this may damage it.

If the patient has kidney problems and is on dialysis, the doctor will advise on how and when to take Pomalidomide Stada.

Duration of treatment with Pomalidomide Stada

Continue treatment cycles until the doctor decides to stop treatment.

Taking a higher dose of Pomalidomide Stada than recommended

If a higher dose of Pomalidomide Stada than recommended is taken, the patient should immediately inform their doctor or go to the hospital. The patient should take the medicine packaging with them.

Missing a dose of Pomalidomide Stada

If the patient misses a dose of Pomalidomide Stada on the day it was supposed to be taken, they should take the next capsule at the scheduled time the next day. Do not take a double dose to make up for the missed capsule of Pomalidomide Stada.

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pomalidomide Stada can cause side effects, although not everybody gets them.

Severe side effects

If any of the following severe side effects occur, stop taking Pomalidomide Stada and immediately consult your doctor - you may need urgent treatment.

• fever, chills, sore throat, cough, mouth ulcers, or any other signs of infection (due to a low number of white blood cells that help fight infections).
• bleeding or bruising without cause, including nosebleeds, gastrointestinal bleeding, or stomach bleeding (due to the effect of the medicine on platelets).
• rapid breathing, rapid heartbeat, fever, and chills, passing very little or no urine, nausea, and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock).
• chest pain or leg pain and swelling (caused by blood clots).
• shortness of breath (due to severe chest infections, pneumonia, heart failure, or blood clots).
• swelling of the face, lips, tongue, and throat, which can cause breathing difficulties (due to severe allergic reactions called angioedema and anaphylaxis).
• certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma) that can cause changes in the appearance of the skin or the formation of growths on the skin. If you notice any changes in your skin while taking Pomalidomide Stada, tell your doctor as soon as possible.
• relapse of hepatitis B virus infection, which can cause yellowing of the skin and eyes (jaundice), dark urine, abdominal pain on the right side, fever, nausea, and vomiting. If you notice these symptoms, immediately consult your doctor.
• widespread rash, high fever, swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). If these symptoms occur, stop taking pomalidomide and consult your doctor or seek immediate medical attention. See also section 2.

If any of the above severe side effects occur, stop taking Pomalidomide Stada and immediately consult your doctor- you may need urgent treatment.

Other side effects

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

• shortness of breath (dyspnea).
• lung infections (pneumonia and bronchitis).
• infections of the nose, sinuses, and throat caused by bacteria or viruses.
• flu-like symptoms (influenza).
• decreased red blood cell count, which can cause fatigue and weakness.
• low potassium levels in the blood (hypokalemia), which can cause weakness, muscle cramps, muscle pain, irregular heartbeat, tingling, or numbness.
• high blood sugar levels.
• rapid and irregular heartbeat (atrial fibrillation).
• loss of appetite.
• constipation, diarrhea, or nausea.
• vomiting.
• abdominal pain.
• fatigue.
• difficulty sleeping or maintaining sleep continuity.
• dizziness, tremors.
• muscle cramps, muscle weakness.
• bone pain, back pain.
• numbness, tingling, or burning sensation in the skin (peripheral sensory neuropathy).
• swelling of the body, including hands and feet.
• rash.
• urinary tract infections, which can cause burning during urination or frequent urination.

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

• dizziness.
• brain bleeding.
• decreased ability to move or feel in the arms, legs, hands, and feet due to nerve damage (peripheral motor and sensory neuropathy).
• tingling, itching, or burning sensation in the skin (paresthesia).
• feeling of spinning, which can make it difficult to maintain a steady position and walk.
• swelling caused by fluid accumulation.
• hives.
• itching.
• shingles.
• heart attack (chest pain radiating to the arms, neck, jaw, sweating, and shortness of breath, nausea, or vomiting).
• chest pain or chest infection.
• high blood pressure.
• decrease in the number of red and white blood cells and platelets (pancytopenia), which can make the patient more prone to bleeding and bruising. The patient may feel tired, weak, and short of breath. The patient is also more prone to infections.
• decrease in lymphocytes (a type of white blood cell), often caused by infection (lymphopenia).
• low magnesium levels in the blood (hypomagnesemia), which can cause fatigue, general weakness, muscle cramps, irritability, and low calcium levels in the blood (hypocalcemia), which can cause numbness, tingling, or burning sensation in the hands, feet, or lips, muscle cramps, muscle weakness, fainting spells, confusion.
• low phosphate levels in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion.
• high calcium levels in the blood (hypercalcemia), which can cause slowed reflexes and muscle weakness.
• high potassium levels in the blood, which can cause irregular heartbeat.
• low sodium levels in the blood, which can cause fatigue, confusion, tremors, seizures (convulsions), or coma.
• high uric acid levels in the blood, which can lead to gout.
• low blood pressure, which can cause dizziness or fainting.
• mouth pain or dry mouth.
• changes in taste.
• abdominal swelling.
• confusion.
• depression.
• loss of consciousness, fainting.
• cataracts.
• kidney damage.
• inability to urinate.
• abnormal liver test results.
• pelvic pain.
• weight loss.

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

• stroke.
• liver inflammation, which can cause itching, yellowing of the skin and eyes (jaundice), light-colored stools, dark urine, and abdominal pain.
• breakdown of cancer cells, leading to the release of toxic substances into the blood (tumor lysis syndrome), which can cause kidney problems.
• underactive thyroid, which can cause fatigue, lethargy, muscle weakness, slow heart rate, weight gain.

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

• rejection of a transplanted solid organ (such as a heart or liver).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel. +48 22 49 21 301, Fax +48 22 49 21 309, website https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pomalidomide Stada

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

Do not use this medicine after the expiry date stated on the blister and carton, respectively, after EXP or Expiry Date (EXP). The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Do not use Pomalidomide Stada if you notice any damage or signs of opening.

Medicines should not be disposed of via wastewater or household waste. After completing treatment, return any unused medicine to the pharmacist. This will help protect the environment.

6. Contents of the pack and other information

What Pomalidomide Stada contains

• The active substance is pomalidomide.
• The other ingredients are isomalt 801 (E953), isomalt 721 (E953), cornstarch, sodium stearyl fumarate.

Pomalidomide Stada 1 mg hard capsule:

• Each hard capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and black printing ink.

Pomalidomide Stada 2 mg hard capsule:

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

Pomalidomide Stada 3 mg hard capsule:

• Each hard capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), and black printing ink.

Pomalidomide Stada 4 mg hard capsule:

• Each hard capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), erythrosine (E127), and black printing ink.

The printing ink contains: shellac (E904), concentrated ammonia solution, potassium hydroxide, black iron oxide (E172).

What Pomalidomide Stada looks like and contents of the pack

Pomalidomide Stada 1 mg hard capsules

Yellow, non-transparent cap and yellow non-transparent body, capsule size 4 (approximately 14 mm x 5 mm) with black printing ink "LP" on the cap and "664" on the body, containing yellow granules

Pomalidomide Stada 2 mg hard capsules

Orange, non-transparent cap and orange non-transparent body, capsule size 3 (approximately 16 mm x 6 mm) with black printing ink "LP" on the cap and "665" on the body, containing yellow granules

Pomalidomide Stada 3 mg hard capsules

Non-transparent cap and body in a powder blue color, capsule size 2 (approximately 18 mm x 6 mm) with black printing ink "LP" on the cap and "690" on the body, containing yellow granules

Pomalidomide Stada 4 mg hard capsules

Blue, non-transparent cap and blue non-transparent body, capsule size 2 (approximately 18 mm x 6 mm) with black printing ink "LP" on the cap and "667" on the body, containing yellow granules

Pack sizes:

Blisters of PVC/PCTFE/Aluminum or OPA/Aluminum/PVC/Aluminum, in a cardboard box:

14 hard capsules (standard blisters)

14 x 1 hard capsule (perforated single-dose blisters)

21 hard capsules (standard blisters)

21 x 1 hard capsule (perforated single-dose blisters)

Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer/Importer:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Qualimetrix S.A.

Mesogeion Avenue 579

Agia Paraskevi

153 43 Athens

Greece

Adalvo Limited

Malta Life Sciences Park Building 1 Level 4

Sir Temi Zammit Buildings

San Gwann Industrial Estate

SGN 3000 San Gwann

Malta

Pharmadox Healthcare Limited

Kw20a Kordin Industrial Park

PLA 3000 Paola

Malta

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Clonmel Healthcare Limited

Waterford Road

E91 D768 Clonmel, Co. Tipperary

Ireland

To get more detailed information, contact the representative of the marketing authorization holder:

Stada Pharm Sp. z o.o.

ul. Krakowiaków 44

02-255 Warsaw

Tel. +48 22 737 79 20

This medicine is authorized in the Member States of the European Economic Area

Available under the following names:

Austria
Pomalidomid STADA 1 mg hard capsules
Pomalidomid STADA 2 mg hard capsules
Pomalidomid STADA 3 mg hard capsules
Pomalidomid STADA 4 mg hard capsules
Belgium
Pomalidomide EG 1 mg hard capsules
Pomalidomide EG 2 mg hard capsules
Pomalidomide EG 3 mg hard capsules
Pomalidomide EG 4 mg hard capsules
Cyprus
Pomalidomide Stada
Denmark
Pomalidomide STADA
Estonia
Pomalidomide STADA
Finland
Pomalidomide STADA 1 mg capsules, hard
Pomalidomide STADA 2 mg capsules, hard
Pomalidomide STADA 3 mg capsules, hard
Pomalidomide STADA 4 mg capsules, hard
France
POMALIDOMIDE EG 1 mg, capsules
POMALIDOMIDE EG 2 mg, capsules
POMALIDOMIDE EG 3 mg, capsules
POMALIDOMIDE EG 4 mg, capsules
Greece
Pomalidomide/Stada
Spain
Pomalidomida STADA 1 mg hard capsules EFG
Pomalidomida STADA 2 mg hard capsules EFG
Pomalidomida STADA 3 mg hard capsules EFG
Pomalidomida STADA 4 mg hard capsules EFG
Netherlands
Pomalidomide CF 1 mg, hard capsules
Pomalidomide CF 2 mg, hard capsules
Pomalidomide CF 3 mg, hard capsules
Pomalidomide CF 4 mg, hard capsules
Ireland
Pomalidomide Clonmel 1 mg hard capsules
Pomalidomide Clonmel 2 mg hard capsules
Pomalidomide Clonmel 3 mg hard capsules
Pomalidomide Clonmel 4 mg hard capsules
Iceland
Pomalidomide STADA 1 mg hard capsules
Pomalidomide STADA 2 mg hard capsules
Pomalidomide STADA 3 mg hard capsules
Pomalidomide STADA 4 mg hard capsules
Lithuania
Pomalidomide STADA 1 mg hard capsules
Pomalidomide STADA 2 mg hard capsules
Pomalidomide STADA 3 mg hard capsules
Pomalidomide STADA 4 mg hard capsules
Luxembourg Pomalidomide EG 1 mg capsules
Pomalidomide EG 2 mg capsules
Pomalidomide EG 3 mg capsules
Pomalidomide EG 4 mg capsules
Latvia
Pomalidomide STADA 1 mg hard capsules
Pomalidomide STADA 2 mg hard capsules
Pomalidomide STADA 3 mg hard capsules
Pomalidomide STADA 4 mg hard capsules
Malta
Pomalidomide Clonmel 1 mg hard capsules
Pomalidomide Clonmel 2 mg hard capsules
Pomalidomide Clonmel 3 mg hard capsules
Pomalidomide Clonmel 4 mg hard capsules
Germany
Pomalidomid AL 1 mg hard capsules
Pomalidomid AL 2 mg hard capsules
Pomalidomid AL 3 mg hard capsules
Pomalidomid AL 4 mg hard capsules
Norway
Pomalidomide STADA
Poland
Pomalidomide Stada
Portugal
Pomalidomida Stada
Romania
Pomalidomidă Stada 1 mg capsules
Pomalidomidă Stada 2 mg capsules
Pomalidomidă Stada 3 mg capsules
Pomalidomidă Stada 4 mg capsules
Slovakia
Pomalidomid STADA 1/2/3/4 mg hard capsules
Slovenia
Pomalidomid STADA 1 mg hard capsules
Pomalidomid STADA 2 mg hard capsules
Pomalidomid STADA 3 mg hard capsules
Pomalidomid STADA 4 mg hard capsules
Sweden
Pomalidomide STADA 1 mg hard capsules
Pomalidomide STADA 2 mg hard capsules
Pomalidomide STADA 3 mg hard capsules
Pomalidomide STADA 4 mg hard capsules
Hungary
Pomalidomide Stada 1 mg hard capsules
Pomalidomide Stada 2 mg hard capsules
Pomalidomide Stada 3 mg hard capsules
Pomalidomide Stada 4 mg hard capsules
Italy
Pomalidomide EG

Date of last update of the leaflet: