Pomalidomide pph

Poland
Brand name Pomalidomide pph
Form capsules, hard
Active substance / Dosage
Prescription type Prescription only – restricted use
ATC code
Registration number 100486583
Pomalidomide pph capsules, hard

Package leaflet: Information for the patient

Pomalidomide PPH, 1 mg, hard capsules
Pomalidomide PPH, 2 mg, hard capsules
Pomalidomide PPH, 3 mg, hard capsules
Pomalidomide PPH, 4 mg, hard capsules
Pomalidomide
It should be expected that Pomalidomide PPH will cause severe birth defects and may
lead to fetal death.

  • Do not take this medicine if you are pregnant or may become pregnant.
  • You must follow the contraceptive advice provided in this leaflet.

Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
  • If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

What Pomalidomide PPH is
Pomalidomide PPH 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 defences).

What Pomalidomide PPH is used for
Pomalidomide PPH is used to treat adults with a type of cancer called "multiple myeloma".
Pomalidomide PPH is used in combination with:

  • two other medicines, bortezomib (a chemotherapy medicine) and dexamethasone (an anti-inflammatory medicine), in patients who have already received at least one other treatment regimen containing lenalidomide or
  • one other medicine, dexamethasone, in patients with multiple myeloma whose disease has worsened despite having previously received at least two other treatment regimens containing lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a cancer that affects a certain type of white blood cells (called plasma cells). These cells grow uncontrollably and accumulate in the bone marrow, causing damage to bones and kidneys.
Multiple myeloma is generally incurable. However, treatment may relieve the signs and symptoms of the disease or cause them to disappear for a period of time—this is called a "response" to treatment.

How Pomalidomide PPH works
Pomalidomide PPH works in several different 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 blood to cancer cells.

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

  • Pomalidomide PPH in combination with bortezomib and dexamethasone typically delayed the recurrence of multiple myeloma by up to 11 months—compared to 7 months in patients who received only bortezomib and dexamethasone.

Benefits of using Pomalidomide PPH with dexamethasone
Pomalidomide PPH, when used in combination with dexamethasone in patients who have already received at least two other treatments, may slow the progression of multiple myeloma.

  • Pomalidomide PPH in combination with dexamethasone typically delayed the recurrence of multiple myeloma by up to 4 months—compared to 2 months in patients who received dexamethasone alone.

2. Important information before taking Pomalidomide PPH

When not to use Pomalidomide PPH

  • if the patient is pregnant, suspects she may be pregnant, or plans to have a child, because Pomalidomide PPH is expected to be harmful to the fetus (men and women taking this medicine must read the section "Pregnancy, contraception and breastfeeding – information for women and men" below).
  • if the patient could become pregnant, unless she uses all required methods of contraception (see section "Pregnancy, contraception and breastfeeding – information for women and men"). If the patient could become pregnant, the doctor will always document at each prescription that necessary precautions have been taken and will confirm this with the patient.
  • if the patient is allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If an allergic reaction to the medicine is suspected, consult a doctor for advice.

If the patient is unsure whether any of the above situations apply, consult a
doctor, pharmacist, or nurse before starting treatment with Pomalidomide PPH.
Warnings and precautions
Before starting treatment with Pomalidomide PPH, discuss with the doctor, pharmacist, or
nurse if:

  • the patient has previously had blood clots. Treatment with Pomalidomide PPH increases the risk of developing blood clots in veins and arteries. The doctor may prescribe additional treatment (e.g., warfarin) or reduce the dose of Pomalidomide PPH to lower the risk of blood clots.
  • the patient has ever had an allergic reaction such as rash, itching, swelling, dizziness, or difficulty breathing while taking similar medicines called “thalidomide” and “lenalidomide.”
  • the patient has had a heart attack, has heart failure, experiences breathing difficulties, or if the patient smokes, has high blood pressure, or high cholesterol levels.
  • the patient has extensive tumor involvement in the body, including in the bone marrow. This may lead to tumor lysis, causing abnormal levels of chemical substances in the blood, which may result in kidney failure. The patient may also experience heart rhythm disturbances. This condition is known as tumor lysis syndrome.
  • the patient has or has had neuropathy (nerve damage causing tingling or pain in hands or feet).
  • the patient has or has had hepatitis B virus infection. Taking Pomalidomide PPH may reactivate the virus in previously infected patients, leading to recurrence of infection. The doctor should check whether the patient has been previously infected with hepatitis B virus.
  • the patient has or has had any of the following symptoms together: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, swollen lymph nodes (observed symptoms of a severe skin reaction known as “drug reaction with eosinophilia and systemic symptoms” (DRESS) or “drug hypersensitivity syndrome,” toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (SJS); see also section 4 “Possible side effects”).

Note that patients with multiple myeloma treated with pomalidomide may develop
additional types of tumors. For this reason, the doctor should carefully evaluate the benefits and risks
associated with prescribing this medicine to the patient.
At any time during or after treatment, immediately inform the doctor
or nurse if the following symptoms occur: vision disturbances, loss of vision, double vision, speech difficulties, weakness in arms or legs, change in walking pattern or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or disorientation.
All of these symptoms may indicate a serious and potentially life-threatening brain condition called
progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before treatment with
Pomalidomide PPH, inform the doctor of any changes in these symptoms.
After treatment, return all unused capsules to the pharmacy, which will accept them.
Pregnancy, contraception and breastfeeding – information for women and men
As indicated below, pregnancy prevention program requirements must be followed during treatment with Pomalidomide PPH.
Women taking Pomalidomide PPH must not become pregnant, and the female partner of a man being treated with pomalidomide must not become pregnant, because this medicine is expected to be harmful to the fetus. The patient and his partner or her partner should use effective contraceptive methods during treatment with this medicine.
Women
Do not use Pomalidomide PPH if the patient is pregnant, suspects she may be pregnant, or plans to have a child, because this medicine is expected to be harmful to the fetus.
Before starting treatment, the patient should inform the doctor that she could become pregnant, even if she considers it unlikely.
If the patient could become pregnant:

  • she must use effective contraception methods for at least 4 weeks before starting treatment, throughout the entire treatment period, and for at least 4 weeks after treatment ends. The patient should discuss with the doctor which method of contraception is best for her.
  • at each prescription, the doctor will ensure that the patient understands all necessary actions required to prevent pregnancy.
  • the doctor will order pregnancy tests before treatment, no less frequently than every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive methods:

  • she must immediately stop treatment and inform the doctor without delay.

Breastfeeding
It is not known whether Pomalidomide PPH passes into human milk. If the patient is breastfeeding or
intends to breastfeed, she must inform her doctor. The doctor will
inform the patient whether she should stop or continue breastfeeding.
Men
Pomalidomide PPH passes into human semen.

  • If the partner is pregnant or could become pregnant, the man must use condoms throughout the entire treatment period and for 7 days after treatment ends.
  • If the female partner of a man undergoing treatment with Pomalidomide PPH becomes pregnant, inform the doctor immediately. The partner should seek medical advice immediately.

The patient must not donate sperm during treatment and for 7 days after treatment ends.
Blood donation and blood tests
During treatment and for 7 days after treatment ends, the patient must not donate blood.
Before and during treatment with Pomalidomide PPH, the doctor will regularly order
blood tests. This is necessary because this medicine may reduce the number of
blood cells (white blood cells) that help fight infections and reduce the number of cells
(platelets) that help stop bleeding.
The doctor should 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 is taking Pomalidomide PPH. The doctor may adjust the dose of Pomalidomide PPH or discontinue treatment based on the patient's blood test results. The doctor may also change the dose or stop treatment due to the patient's general health condition.

Children and adolescents
Pomalidomide PPH is not recommended for use in children and adolescents under 18 years of age.
Pomalidomide PPH and other medicines
Tell the doctor, pharmacist, or nurse about all medicines the patient is currently taking, has recently taken, or plans to take, because Pomalidomide PPH may affect the action of other medicines. Likewise, other medicines may affect the action of Pomalidomide PPH.
Before taking Pomalidomide PPH, inform the doctor, pharmacist, or nurse,
especially if the patient is 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
While taking Pomalidomide PPH, some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness. If such symptoms occur, the patient should not drive, use tools, or operate machinery.
Pomalidomide PPH
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free."

3. How to take Pomalidomide PPH

Pomalidomide PPH must be prescribed by a physician experienced in the treatment of multiple myeloma.
This medicine should always be taken exactly as directed by the physician. If in doubt, consult the
doctor, pharmacist, or nurse.

When to take Pomalidomide PPH with other medicines
Pomalidomide PPH with bortezomib and dexamethasone

  • Refer to the package leaflets provided with bortezomib and dexamethasone for further information regarding their use and effects.
  • Pomalidomide PPH, bortezomib, and dexamethasone are administered in treatment cycles. Each cycle lasts 21 days (3 weeks).
  • Review the table below to determine which medicines should be taken on each day of the 3-week cycle.
  • Each day, check the table to see which medicines should be taken on that day.
  • On some days, all three medicines should be taken; on other days, only two or one medicine may be taken, and on some days, no medicines should be taken.

POM: pomalidomide; BOR: bortezomib; DEX: dexamethasone
Cycles 1 to 8 Cycle 9 and onwards
Medicine name Medicine 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, begin a new cycle.

Pomalidomide PPH with dexamethasone only

  • Refer to the package leaflet provided with dexamethasone for further information regarding its use and effects.
  • Pomalidomide PPH and dexamethasone are administered in treatment cycles. Each cycle lasts 28 days (4 weeks).
  • Review the table below to determine which medicines should be taken on each day of the 4-week cycle.
  • Each day, check the table to see which medicines should be taken on that day.
  • On some days, both medicines should be taken; on other days, only one medicine may be taken, and on some days, no medicines should be taken.

POM: pomalidomide; DEX: dexamethasone
Medicine name
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 √

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

What dose of Pomalidomide PPH should be taken with other medicines
Pomalidomide PPH with bortezomib and dexamethasone

  • The recommended starting dose of Pomalidomide PPH is 4 mg once daily.
  • The recommended starting dose of bortezomib will be determined by the physician based on the patient's height and body weight (1.3 mg/m² body surface area).
  • The recommended starting dose of dexamethasone is 20 mg once daily. However, if the patient is over 75 years of age, the recommended starting dose is 10 mg once daily.

Pomalidomide PPH with dexamethasone only

  • The recommended dose of Pomalidomide PPH is 4 mg once daily.
  • The recommended starting dose of dexamethasone is 40 mg once daily. However, if the patient is over 75 years of age, the recommended starting dose is 20 mg once daily.

The physician may reduce the dose of Pomalidomide PPH, bortezomib, or dexamethasone, or discontinue
treatment with one or more of these medicines, depending on the patient's blood test results, overall
health status, concomitant use of other medicines (e.g. ciprofloxacin, enoxacin, and fluvoxamine), and
if treatment-related adverse reactions occur (especially rash or swelling). If the patient has liver or
kidney disease, the treating physician will closely monitor the patient's health during treatment.

How to take Pomalidomide PPH

  • 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 and thoroughly with soap and water.
  • Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly 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.
  • The capsules may be taken with or without food.
  • The capsules should be taken at approximately the same time each day.

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

Diagram illustrating instructions for opening a medication package, showing hands and fingers lifting and peeling back individual parts of a blister pack containing a tablet

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

Duration of treatment with Pomalidomide PPH
Continue treatment cycles until the physician decides to discontinue therapy.

Accidental overdose of Pomalidomide PPH
If a dose of Pomalidomide PPH higher than recommended is taken, contact the physician immediately or go to the hospital. Bring the medicine packaging with you.

Missed dose of Pomalidomide PPH
If a dose of Pomalidomide PPH is missed on the day it should have been taken, take the next capsule at the usual time the following day. Do not take a double dose to make up for the missed capsule of Pomalidomide PPH.

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

4. Possible adverse reactions

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

Serious adverse reactions
If any of the following serious adverse reactions occur, stop taking Pomalidomide PPH and contact a doctor immediately – 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, which help fight infection)
  • bleeding or bruising without cause, including nosebleeds, intestinal or stomach bleeding (due to the medicine's effect on blood cells called platelets)
  • rapid breathing, fast 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 diarrhoea (also with abdominal pain or fever) caused by bacteria called Clostridium difficile
  • chest pain or leg pain and swelling, especially in the calf and lower leg (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 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 the development of skin growths. If a patient notices any skin changes while taking Pomalidomide PPH, they should report it to their doctor as soon as possible
  • reactivation of hepatitis B virus infection, which may cause yellowing of the skin and whites of the eyes, dark brown urine, right-sided abdominal pain, fever, nausea and vomiting. Seek medical advice immediately if any of these symptoms occur.
  • widespread rash, high fever, swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome). If these symptoms occur, stop taking pomalidomide immediately and contact a doctor or seek urgent medical help. See also section 2.

If any of the above serious adverse reactions occur, stop taking Pomalidomide PPH and contact a doctor immediately – immediate treatment may be necessary.

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

  • shortness of breath (dyspnoea)
  • lung infections (pneumonia and bronchitis)
  • bacterial or viral infections of the nose, sinuses and throat
  • flu-like symptoms (influenza)
  • reduced number of red blood cells, possibly leading to anaemia causing fatigue and weakness
  • low blood potassium levels (hypokalaemia), which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, 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 asleep or staying asleep
  • dizziness, tremor
  • muscle cramps, muscle weakness
  • bone pain, back pain
  • numbness, tingling or burning sensation of the skin, pain in hands or feet (sensory peripheral neuropathy)
  • swelling of the body, including hands and feet
  • rash
  • urinary tract infection, which may cause burning when passing urine or a need to pass urine more frequently

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

  • fall
  • bleeding within the skull
  • reduced ability to move or feel in the hands, arms, feet and legs due to nerve damage (sensory-motor peripheral neuropathy)
  • numbness, itching and tingling of the skin (paraesthesia)
  • sensation of spinning in the head, making it difficult to maintain proper standing posture and normal movement
  • swelling caused by fluid accumulation
  • hives (urticaria)
  • itchy skin
  • shingles (herpes zoster)
  • heart attack (chest pain spreading to arms, neck, jaw, feeling of sweating and shortness of breath, nausea or vomiting)
  • chest pain, infection in the chest area
  • high blood pressure
  • simultaneous reduction in red blood cells, white blood cells and platelets (pancytopenia), leading to increased susceptibility to bleeding and bruising. The patient may feel tired, weak, short of breath and more prone to infections.
  • reduced number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia)
  • low blood magnesium levels (hypomagnesaemia), which may cause fatigue, general weakness, muscle cramps, irritability and may lead to low blood calcium levels (hypocalcaemia), which may cause numbness and/or tingling in hands, feet or lips, muscle cramps, muscle weakness, feeling of emptiness in the head, confusion
  • low blood phosphate levels (hypophosphataemia), which may cause muscle weakness, irritability or confusion
  • high blood calcium levels (hypercalcaemia), which may cause slowed reflexes and skeletal muscle weakness
  • high blood potassium levels, which may cause irregular heartbeat
  • low blood sodium levels, which may cause fatigue and confusion, muscle twitching, seizures (epileptic fits) or coma
  • high blood uric acid levels, which may lead to joint inflammation in the form of gout
  • low blood pressure, which may cause dizziness or fainting
  • pain or dryness in the mouth
  • changes in taste sensation
  • abdominal bloating
  • feeling confused
  • depression
  • loss of consciousness, fainting
  • clouding of the eye (cataract)
  • kidney damage
  • inability to pass urine
  • abnormal liver function tests
  • pelvic pain
  • weight loss

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

  • stroke
  • hepatitis, which may cause itchy skin, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine and abdominal pain
  • tumour lysis syndrome – breakdown of tumour cells leading to the release of toxic substances into the blood. This may lead to kidney problems.
  • hypothyroidism, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate and weight gain

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

  • rejection of transplanted solid organs (such as heart or liver)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pomalidomide PPH

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 the cardboard box after: EXP. The expiry date refers to the last day of the specified month.
The label on the packaging shows the expiry date after the abbreviation EXP and the batch number after the abbreviation Lot.
There are no special storage requirements for this medicine.
Do not use this medicine if you notice any damage to or signs of tampering with the packaging.
Medicines must not be disposed of via the sewage system or household waste. After completion of treatment, any unused medicine should be returned to a pharmacy, which will accept it. This will help protect the environment.

6. Contents of the pack and other information

What Pomalidomide PPH contains

  • The active substance is pomalidomide.
  • The other ingredients are: microcrystalline cellulose (E460), maltodextrin, sodium stearyl fumarate.

Pomalidomide PPH 1 mg, hard capsules

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

Pomalidomide PPH 2 mg, hard capsules

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

Pomalidomide PPH 3 mg, hard capsules

  • Each hard capsule contains 3 mg of pomalidomide.
  • The capsule shell contains: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172), white ink.
  • Printing ink contains: shellac glaze, titanium dioxide (E171), propylene glycol.

Pomalidomide PPH 4 mg, hard capsules

  • Each hard capsule contains 4 mg of pomalidomide.
  • The capsule shell contains: gelatin, titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), yellow iron oxide (E172), red iron oxide (E172), white ink.
  • Printing ink contains: shellac glaze, titanium dioxide (E171), propylene glycol.

What Pomalidomide PPH looks like and contents of the pack
Pomalidomide PPH 1 mg, hard capsules
Hard gelatin capsule with a yellow body and red cap, printed in white with "PLM 1" along the axis of the body.

Pomalidomide PPH 2 mg, hard capsules
Hard gelatin capsule with an orange body and red cap, printed in white with "PLM 2" along the axis of the body.

Pomalidomide PPH 3 mg, hard capsules
Hard gelatin capsule with a turquoise body and red cap, printed in white with "PLM 3" along the axis of the body.

Pomalidomide PPH 4 mg, hard capsules
Hard gelatin capsule with a dark blue body and red cap, printed in white with "PLM 4" along the axis of the body.

Pack sizes: 14, 21, 14x1 or 21x1 capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Synthon Hispania S.L.
Calle De Castello 1
Sant Boi De Llobregat
Barcelona 08830
Spain

Synthon B.V.
Microweg 22
Nijmegen
Gelderland
6545 CM
The Netherlands

This medicinal product is authorised in the European Economic Area under the following names:
Austria: Pomalidomid +pharma 1 mg, 2 mg, 3 mg, 4 mg, Hartkapseln
Greece: POMALIDOMIDE/FARAN
Finland: Pomalidomid Avansor
Iceland: Pomalidomide WH
The Netherlands: Pomalidomide Synthon 1 mg, 2 mg, 3 mg, 4 mg, harde capsules
Romania: Pomalidomidă Dr. Reddy’s 1 mg, 2 mg, 3 mg, 4 mg, capsule
Sweden: Pomalidomid Avansor
Hungary: Pomalidomid Onkogen 4 mg kemény kapszula