Pomalidomide Sandoz

Leaflet accompanying the packaging: patient information

Pomalidomide Sandoz, 1 mg, hard capsules

Pomalidomide Sandoz, 2 mg, hard capsules

Pomalidomide Sandoz, 3 mg, hard capsules

Pomalidomide Sandoz, 4 mg, hard capsules

Pomalidomide

It is expected that Pomalidomide Sandoz 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.
• The patient must follow the advice on contraception given in this leaflet.

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

• The patient should keep this leaflet to be able to read it again if necessary.
• In case of any doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It must not be given 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 Sandoz and what is it used for
• 2. Important information before taking Pomalidomide Sandoz
• 3. How to take Pomalidomide Sandoz
• 4. Possible side effects
• 5. How to store Pomalidomide Sandoz
• 6. Contents of the packaging and other information

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

What is Pomalidomide Sandoz

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

What is Pomalidomide Sandoz used for

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

Pomalidomide Sandoz 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 multiple myeloma whose condition 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 affects a type of white blood cell called plasma cells. These cells grow uncontrollably and accumulate in the bone marrow, causing damage to the bones and kidneys.

Multiple myeloma usually cannot be cured. However, treatment can alleviate the symptoms of the disease and make them disappear for a while - this is called a "response" to treatment.

How does Pomalidomide Sandoz work

Pomalidomide Sandoz 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 supply cancer cells.

Benefits of using Pomalidomide Sandoz with bortezomib and dexamethasone

Pomalidomide Sandoz 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 recurrence of multiple myeloma by 11 months - compared to 7 months in patients who received only bortezomib and dexamethasone.

Benefits of using Pomalidomide Sandoz with dexamethasone

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

2. Important information before taking Pomalidomide Sandoz

When not to take Pomalidomide Sandoz:

• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant - because it is expected that Pomalidomide Sandoz 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 she uses all necessary measures to prevent pregnancy (see the section "Pregnancy, contraception, and breastfeeding - information for men and women"). If the patient may become pregnant, the doctor will ensure that the patient understands the necessary measures to prevent pregnancy and will provide confirmation to the patient.
• if the patient is allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If the patient suspects an allergy to the medicine, they should consult a doctor for advice.

If the patient is unsure whether any of the above situations apply to them, they should consult a doctor, pharmacist, or nurse before starting to take Pomalidomide Sandoz.

Warnings and precautions

Before starting to take Pomalidomide Sandoz, the patient should discuss with their doctor, pharmacist, or nurse if:

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

2

The patient should emphasize that in patients with multiple myeloma treated with pomalidomide, there may be an increased risk of developing additional types of cancer. Therefore, the treating doctor should carefully assess the benefits and risks associated with prescribing this medicine to the patient.

At any time during treatment or after its completion, the patient should immediately inform their doctor or nurse if they experience: blurred vision, loss of vision, or double vision, difficulty speaking, weakness in the arms or legs, change in gait, or balance problems, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation. All these symptoms may indicate a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before taking Pomalidomide Sandoz, the patient should inform their doctor about any changes in these symptoms.

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

During treatment with Pomalidomide Sandoz, the patient must follow the recommendations specified in the pregnancy prevention program. Women taking Pomalidomide Sandoz must not become pregnant, and men taking Pomalidomide Sandoz must not father a child, as it is expected that this medicine will harm the fetus. Both the patient and their partner must use effective contraception during treatment with this medicine.

Women

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

If the patient may become pregnant:

• she must use effective methods of pregnancy prevention for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after completing treatment. The patient should discuss with her doctor which method of pregnancy prevention is best for her.
• each time the medicine is prescribed, the doctor will ensure that the patient understands the necessary measures to prevent pregnancy.
• the doctor will order pregnancy tests before treatment, no less frequently than every 4 weeks during treatment, and after at least 4 weeks after completing 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 Sandoz passes into human milk. If the patient is breastfeeding or plans to breastfeed, she must tell her doctor. The doctor will advise the patient whether to stop or continue breastfeeding.

Men

Pomalidomide Sandoz passes into 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 completing treatment.
• if the patient's partner becomes pregnant during treatment with Pomalidomide Sandoz, the patient must inform their doctor immediately. The partner should also consult a doctor immediately.

The patient must not donate sperm (semen) during treatment and for 7 days after completing treatment.

Blood donation and blood tests

During treatment and for 7 days after completing treatment, the patient must not donate blood.

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

The doctor will order blood tests:

• before treatment
• weekly during the first 8 weeks of treatment
• then at least once a month for as long as the patient takes Pomalidomide Sandoz.

The doctor may change the dose of Pomalidomide Sandoz or stop treatment 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).

Children and adolescents

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

Pomalidomide Sandoz and other medicines

The patient must tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, as Pomalidomide Sandoz may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Sandoz.

Before taking Pomalidomide Sandoz, the patient must inform their doctor, pharmacist, or nurse, in particular, if they are taking any of the following medicines:

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

Driving and using machines

During treatment with Pomalidomide Sandoz, some patients may experience fatigue, dizziness, fainting, disorientation, or decreased alertness. If these symptoms occur, the patient must not drive, use tools, or operate machines.

Pomalidomide Sandoz contains sodium

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

3. How to take Pomalidomide Sandoz

Pomalidomide Sandoz must be prescribed by a doctor with experience in treating multiple myeloma.

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult a doctor, pharmacist, or nurse.

When to take Pomalidomide Sandoz with other medicines

Pomalidomide Sandoz with bortezomib and dexamethasone

• The patient should read the leaflets accompanying the medicines bortezomib and dexamethasone for further information on their use and action.
• Pomalidomide Sandoz, 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 in the table and check which medicines to take. On some days, the patient will take all 3 medicines, on some days 2 medicines, and on some days no medicines.

5

POM: Pomalidomide; BOR: bortezomib; DEX: dexamethasone

• After completing each 3-week cycle, the patient should start a new cycle.

Pomalidomide Sandoz only with dexamethasone

• The patient should read the leaflet accompanying the medicine dexamethasone for further information on its use and action.
• Pomalidomide Sandoz 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 in the table and check which medicines to take. On some days, the patient will take both medicines, on some days 1 medicine, and on some days no medicine.

6

POM: Pomalidomide; DEX: dexamethasone

• After completing each 4-week cycle, the patient should start a new cycle.

What dose of Pomalidomide Sandoz to take with other medicines

Pomalidomide Sandoz with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Sandoz 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, in patients over 75 years of age, the recommended starting dose is 10 mg per day.

Pomalidomide Sandoz only with dexamethasone

• The recommended dose of Pomalidomide Sandoz is 4 mg per day.
• The recommended starting dose of dexamethasone is 40 mg per day. However, in patients over 75 years of age, the recommended starting dose is 20 mg per day.

The doctor may reduce the dose of Pomalidomide Sandoz, 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).

7

If the patient has kidney or liver disease, the doctor will closely monitor their condition during treatment with this medicine.

How to take Pomalidomide Sandoz

• Do not break, open, or chew the capsules. If the powder from a damaged 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. The gloves should then be carefully removed to avoid skin exposure, placed in a sealed plastic bag, and disposed of according to local regulations. Then, wash hands thoroughly with soap and water. Pregnant or potentially pregnant women should not touch the blister or capsule. The capsules should be swallowed whole, preferably with water. The capsules can be taken with or without food. Pomalidomide Sandoz should be taken at approximately the same time every day.

To remove a capsule from the blister, press the blister only at one end of the capsule and push it out through the foil. Do not press the blister in the middle of the capsule, as this may damage the capsule.

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

Duration of treatment with Pomalidomide Sandoz

The patient should continue treatment cycles until the doctor advises to stop treatment.

Taking a higher dose of Pomalidomide Sandoz than recommended

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

Missing a dose of Pomalidomide Sandoz

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

In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

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

Severe side effects

If the patient experiences any of the following severe side effects, they should stop taking Pomalidomide Sandoz and immediately consult their doctor - immediate treatment may be necessary:

• fever, chills, sore throat, cough, mouth ulcers, or any other signs of infection (due to a lower number of white blood cells that fight infection) bleeding or bruising without cause, including nosebleeds, gastrointestinal bleeding, or bleeding in the brain (due to the effect of the medicine on blood cells called 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)
• severe, persistent, or bloody diarrhea (also with abdominal pain or fever) caused by bacteria called Clostridium difficile
• chest pain or leg pain and swelling, especially in the legs and ankles (caused by blood clots)
• swelling of the face, lips, tongue, and throat, which can cause difficulty breathing (due to serious allergic reactions called angioedema and anaphylaxis)
• some types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of the skin or the formation of growths on the skin. If the patient notices any changes on the skin while taking Pomalidomide Sandoz, they should inform their doctor as soon as possible.
• reactivation of hepatitis B virus infection, which can cause yellowing of the skin and eyes, dark urine, abdominal pain, fever, nausea, and vomiting. The patient should immediately consult their doctor if they notice these symptoms.
• widespread rash, high body temperature, 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, the patient should immediately stop taking pomalidomide and consult a doctor or seek immediate medical attention. See also section 2.

If the patient experiences any of the above severe side effects, they should stop taking Pomalidomide Sandoz and immediately consult their doctor- immediate treatment may be necessary.

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)
• decrease in red blood cells, which can cause fatigue and weakness
• low levels of potassium in the blood (hypokalemia), which can cause weakness, muscle cramps, muscle pain, irregular heartbeat, tingling, or numbness, shortness of breath, mood changes
• high blood sugar levels
• rapid and irregular heartbeat (atrial fibrillation)
• loss of appetite
• constipation, diarrhea, or nausea
• vomiting
• abdominal pain
• lack of energy
• difficulty sleeping or maintaining sleep continuity
• dizziness, tremors
• muscle cramps, muscle weakness
• bone pain, back pain
• numbness, tingling, or burning sensation in the skin, pain in the hands or feet (peripheral sensory neuropathy)
• swelling of the body, including hands and feet
• rash
• urinary tract infection, which can cause burning during urination or frequent urination.

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

• falls
• bleeding in the brain
• decreased ability to move or feel in the arms, legs, hands, and feet due to nerve damage (peripheral sensory-motor neuropathy)
• numbness, tingling, and 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, infection in the chest
• high blood pressure
• simultaneous decrease in red and white blood cells and platelets (pancytopenia), which can cause increased susceptibility to bleeding and bruising. The patient may feel tired, weak, and short of breath, and be more prone to infections
• decrease in lymphocytes (a type of white blood cell), often caused by infection (lymphopenia)
• low levels of magnesium in the blood (hypomagnesemia), which can cause fatigue, general weakness, muscle cramps, irritability, and low levels of calcium in the blood (hypocalcemia), which can cause numbness and tingling in the hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion
• low levels of phosphates in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion
• high levels of calcium in the blood (hypercalcemia), which can cause slowed reflexes and muscle weakness
• high levels of potassium in the blood, which can cause abnormal heart rhythm
• low levels of sodium in the blood, which can cause fatigue and confusion, tremors, seizures (epileptic fits), or coma
• high levels of uric acid in the blood, which can lead to joint inflammation (gout)
• low blood pressure, which can cause dizziness or fainting
• mouth pain or dryness
• changes in taste
• swelling of the abdomen
• confusion
• depression
• loss of consciousness, fainting
• cloudy vision (cataract)
• 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, 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 disease
• underactive thyroid, which can cause fatigue, lethargy, muscle weakness, slow heartbeat, 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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, it is possible to gather more information on the safety of this medicine.

5. How to store Pomalidomide Sandoz

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after 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 this medicine if the patient notices any damage or signs of opening of the packaging.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pomalidomide Sandoz contains

• The active substance is pomalidomide.
• The other ingredients are microcrystalline cellulose (E 460), maltodextrin, and sodium stearyl fumarate.

Pomalidomide Sandoz, 1 mg, hard capsules

• Each capsule contains 1 mg of pomalidomide.
• The capsule body contains gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172), and white ink.
• The white ink contains shellac, titanium dioxide (E 171), and propylene glycol.

Pomalidomide Sandoz, 2 mg, hard capsules

• Each capsule contains 2 mg of pomalidomide.
• The capsule body contains gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172), and white ink.
• The white ink contains shellac, titanium dioxide (E 171), and propylene glycol.

Pomalidomide Sandoz, 3 mg, hard capsules

• Each capsule contains 3 mg of pomalidomide.
• The capsule body contains gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and indigo carmine (E 132), and white ink.
• The white ink contains shellac, titanium dioxide (E 171), and propylene glycol.

Pomalidomide Sandoz, 4 mg, hard capsules

• Each capsule contains 4 mg of pomalidomide.
• The capsule body contains gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132), and erythrosine, and white ink.
• The white ink contains shellac, titanium dioxide (E 171), and propylene glycol.

What Pomalidomide Sandoz looks like and contents of the pack

Pomalidomide Sandoz, 1 mg, hard capsules

Hard gelatin capsule with a yellow body and a red cap, with white printing "PLM 1" along the body of the capsule.

Pomalidomide Sandoz, 2 mg, hard capsules

Hard gelatin capsule with an orange body and a red cap, with white printing "PLM 2" along the body of the capsule.

Pomalidomide Sandoz, 3 mg, hard capsules

Hard gelatin capsule with a turquoise body and a red cap, with white printing "PLM 3" along the body of the capsule.

Pomalidomide Sandoz, 4 mg, hard capsules

Hard gelatin capsule with a dark blue body and a red cap, with white printing "PLM 4" along the body of the capsule.

The hard capsules are packaged in blisters or single-dose blisters in a cardboard box.

The pack contains 14, 21, 56, 63, 14x1, or 21x1 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50C

02-672 Warsaw

tel. 22 209 70 00

Manufacturer

Synthon Hispania S.L.

Calle De Castello 1

08830 Sant Boi De Llobregat

Barcelona, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands

Pomalidomide Sandoz 1 mg, hard capsules

Pomalidomide Sandoz 2 mg, hard capsules

Pomalidomide Sandoz 3 mg, hard capsules

Pomalidomide Sandoz 4 mg, hard capsules

Austria

Pomalidomid Sandoz 1 mg - Hartkapseln

Pomalidomid Sandoz 2 mg - Hartkapseln

Pomalidomid Sandoz 3 mg - Hartkapseln

Pomalidomid Sandoz 4 mg - Hartkapseln

Czech Republic

Pomalidomide Sandoz

Cyprus

Pomalidomide/Sandoz

Germany

Pomalidomid HEXAL 1 mg Hartkapseln

Pomalidomid HEXAL 2 mg Hartkapseln

Pomalidomid HEXAL 3 mg Hartkapseln

Pomalidomid HEXAL 4 mg Hartkapseln

Denmark

Pomalidomide Sandoz

Estonia

Pomalidomide Sandoz

Greece

Pomalidomide/Sandoz

Spain

Pomalidomida Sandoz 1 mg cápsulas duras EFG

Pomalidomida Sandoz 2 mg cápsulas duras EFG

Pomalidomida Sandoz 3 mg cápsulas duras EFG

Pomalidomida Sandoz 4 mg cápsulas duras EFG

Finland

Pomalidomide Sandoz 1 mg kapselit, kovat

Pomalidomide Sandoz 2 mg kapselit, kovat

Pomalidomide Sandoz 3 mg kapselit, kovat

Pomalidomide Sandoz 4 mg kapselit, kovat

France

POMALIDOMIDE SANDOZ 1 mg, gélule

POMALIDOMIDE SANDOZ 2 mg, gélule

POMALIDOMIDE SANDOZ 3 mg, gélule

POMALIDOMIDE SANDOZ 4 mg, gélule

Hungary

Pomalidomide Sandoz 1 mg kemény kapszula

Pomalidomide Sandoz 2 mg kemény kapszula

Pomalidomide Sandoz 3 mg kemény kapszula

Pomalidomide Sandoz 4 mg kemény kapszula

Iceland

Pomalidomide Sandoz

Ireland

Pomalidomide Rowex 1 mg hard capsules

Pomalidomide Rowex 2 mg hard capsules

Pomalidomide Rowex 3 mg hard capsules

Pomalidomide Rowex 4 mg hard capsules

Italy

Pomalidomide Sandoz

Latvia

Pomalidomide Sandoz 1 mg cietā kapsula

Pomalidomide Sandoz 2 mg cietā kapsula

Pomalidomide Sandoz 3 mg cietā kapsula

Pomalidomide Sandoz 4 mg cietā kapsula

Lithuania

Pomalidomide Sandoz 1 mg kietosios kapsulės

Pomalidomide Sandoz 2 mg kietosios kapsulės

Pomalidomide Sandoz 3 mg kietosios kapsulės

Pomalidomide Sandoz 4 mg kietosios kapsulės

Malta

Pomalidomide Sandoz 1 mg capsule, hard

Pomalidomide Sandoz 2 mg capsule, hard

Pomalidomide Sandoz 3 mg capsule, hard

Pomalidomide Sandoz 4 mg capsule, hard

Norway

Pomalidomide Sandoz

Poland

Pomalidomide Sandoz

Portugal

Pomalidomida Sandoz 1 mg cápsulas duras

Pomalidomida Sandoz 2 mg cápsulas duras

Pomalidomida Sandoz 3 mg cápsulas duras

Pomalidomida Sandoz 4 mg cápsulas duras

Romania

Pomalidomida Sandoz 1 mg, capsule

Pomalidomida Sandoz 2 mg, capsule

Pomalidomida Sandoz 3 mg, capsule

Pomalidomida Sandoz 4 mg, capsule

Slovakia

Pomalidomide Sandoz 1 mg

Pomalidomide Sandoz 2 mg

Pomalidomide Sandoz 3 mg

Pomalidomide Sandoz 4 mg

Slovenia

Pomalidomid Sandoz 1 mg trde kapsule

Pomalidomid Sandoz 2 mg trde kapsule

Pomalidomid Sandoz 3 mg trde kapsule

Pomalidomid Sandoz 4 mg trde kapsule

Sweden

Pomalidomide Sandoz

Date of last revision of the leaflet:06/2025

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