Pomalidomide pph

Poland
Brand name Pomalidomide pph
Form capsules, hard
Active substance / Dosage
Prescription type Prescription only – restricted use
ATC code
Registration number 100486603
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 is 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 if you could become pregnant.
  • You must follow the contraception advice provided in this leaflet.

Please read this leaflet carefully before taking this medicine, as it contains important information for you.

  • Keep this leaflet, so that you can read it again if necessary.
  • If you have any questions, please consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

  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 prior 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 treatment regimens including 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, leading to bone and kidney damage.
Generally, multiple myeloma is incurable. However, treatment may relieve the signs and symptoms of the disease or cause the disease to go into remission for a period of time—this is known as 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 tumour cells with blood.

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

  • Pomalidomide PPH in combination with bortezomib and dexamethasone typically delayed the recurrence of multiple myeloma for 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 received at least two prior treatment regimens, may slow the progression of multiple myeloma.

  • Pomalidomide PPH in combination with dexamethasone typically delayed the recurrence of multiple myeloma for 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 unborn child (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 the 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 a 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 reduce 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 tumour involvement in the body, including in the bone marrow. This may lead to tumour lysis, resulting in abnormal levels of certain chemicals in the blood, which may lead to kidney failure. The patient may also experience heart rhythm disturbances. This condition is known as tumour lysis syndrome.
  • the patient has or has had neuropathy (nerve damage causing tingling or pain in the 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 a recurrence of infection. The doctor should check whether the patient has previously been infected with hepatitis B virus.
  • the patient has had or currently has 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").

It should be noted that patients with multiple myeloma treated with pomalidomide may develop
additional types of tumours. For this reason, the 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, immediately inform the doctor
or nurse if the following occur: vision disturbances, loss of vision or double vision, difficulty
speaking, 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 the above 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 completion of treatment, return all unused capsules to a pharmacy, which will accept them.
Pregnancy, contraception and breastfeeding – information for women and men
As indicated below, pregnancy prevention programme requirements must be followed
during treatment with Pomalidomide PPH.
Women taking Pomalidomide PPH must not become pregnant, and the partner of a man being treated with pomalidomide must not become pregnant, because this medicine is expected to be harmful to the unborn child. The patient and his partner / her partner should use effective contraception 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 unborn child.
Before starting treatment, the patient should inform the doctor if 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 treatment period, and for at least 4 weeks after stopping treatment. 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 for at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive methods:

  • she must immediately stop treatment and immediately inform the doctor.

Breastfeeding
It is not known whether Pomalidomide PPH passes into human milk. If the patient is breastfeeding or
plans to breastfeed, she must inform her treating doctor. The treating 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 partner of a man undergoing treatment with Pomalidomide PPH becomes pregnant, immediately inform the doctor. The partner should immediately consult a doctor.

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
platelets that help stop bleeding.
The doctor should order blood tests for the patient:

  • before treatment,
  • weekly during the first 8 weeks of treatment,
  • thereafter 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 adjust the dose or discontinue 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
Inform 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 operating machinery
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
The 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 doctor experienced in the treatment of multiple myeloma.
This medicine should always be taken exactly as directed by the doctor. If in doubt, consult the
doctor, pharmacist or nurse.

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

  • Read the package leaflets provided with bortezomib and dexamethasone for further information on their use and effects.
  • Pomalidomide PPH, bortezomib and dexamethasone are used in treatment cycles. Each cycle lasts 21 days (3 weeks).
  • Refer to the table below to see which medicines should be taken on each day of the 3-week cycle:
  • Each day, check the table to determine 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

  • Read the package leaflet provided with dexamethasone for further information on its use and effects.
  • Pomalidomide PPH and dexamethasone are used in treatment cycles. Each cycle lasts 28 days (4 weeks).
  • Refer to the table below to see which medicines should be taken on each day of the 4-week cycle:
  • Each day, check the table to determine 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 doctor 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 doctor 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, general
health status, use of other medicines (e.g. ciprofloxacin, enoxacin and fluvoxamine), and if the patient
experiences treatment-related adverse effects (especially rash or swelling). If the patient has liver or
kidney disease, the treating doctor will closely monitor the patient's health during treatment with this
medicine.

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 then 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 should 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, 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.

Schematic instruction for opening a medication package showing fingers pressing and peeling back a section of the blister to remove the tablet

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

Duration of treatment with Pomalidomide PPH
Continue treatment cycles until the doctor decides to stop treatment.

Accidentally taking more Pomalidomide PPH than recommended
If more Pomalidomide PPH has been taken than recommended, contact the doctor immediately or go to hospital. Take the medicine packaging with you.

Missing a 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 a missed Pomalidomide PPH capsule.

If you have any further questions about the use of this medicine, ask 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 immediately and seek medical advice without delay – immediate treatment may be necessary.

  • fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to reduced number of white blood cells which help fight infection)
  • bleeding or bruising without cause, including nosebleeds, intestinal or stomach bleeding (due to the effect of the medicine 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, particularly in the calf and shin (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 breathing difficulties (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 the patient notices any skin changes while taking Pomalidomide PPH, this should be reported to the doctor as quickly 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 immediate medical advice 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 any of 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 immediately and seek medical advice without delay – 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, which may lead 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 during urination or increased frequency of urination

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

  • fall
  • intracranial haemorrhage
  • 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 due to fluid accumulation (oedema)
  • urticaria
  • itching of the 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, chest infection
  • 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, generalised weakness, muscle cramps, irritability and may lead to low blood calcium levels (hypocalcaemia), which may cause numbness and/or tingling of 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 heart rhythm
  • 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 itching of the 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, which 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 the 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 also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 to provide more information on the safety of the medicine.

5. How to store Pomalidomide PPH

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 cardboard packaging
after: EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice any damage or signs of tampering with the packaging.
Medicines must not be disposed of via wastewater 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), indigotine (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), indigotine (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
Yellow-bodied, red-capped hard gelatin capsule with white print "PLM 1" along the body axis.

Pomalidomide PPH 2 mg, hard capsules
Orange-bodied, red-capped hard gelatin capsule with white print "PLM 2" along the body axis.

Pomalidomide PPH 3 mg, hard capsules
Turquoise-bodied, red-capped hard gelatin capsule with white print "PLM 3" along the body axis.

Pomalidomide PPH 4 mg, hard capsules
Dark blue-bodied, red-capped hard gelatin capsule with white print "PLM 4" along the body axis.

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 countries 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