Pomalidomide pph

Poland
Brand name Pomalidomide pph
Form capsules, hard
Active substance / Dosage
Prescription type Prescription only – restricted use
ATC code
Registration number 100486610
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
Pomalidomide PPH is expected to 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, as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, please 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 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 containing lenalidomide or
  • one other medicine, dexamethasone, in patients with multiple myeloma whose condition has worsened despite having previously received at least two prior treatments 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, leading to bone and kidney damage.
Multiple myeloma is generally considered incurable. However, treatment may relieve symptoms and signs 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 already 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 already received at least two prior treatments, 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 baby (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 measures 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 to take Pomalidomide PPH.
Warnings and precautions
Before starting treatment with Pomalidomide PPH, discuss with the doctor, pharmacist, or
nurse if:

  • the patient has ever had blood clots in the past. 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 experienced 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 he or she 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 chemical substances, which may cause 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 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 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”).

Please note 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 any of the following symptoms 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 taking
Pomalidomide PPH, inform the doctor of any changes in these symptoms.
After completion, return all unused capsules to the pharmacy, which will accept them.
Pregnancy, contraception and breastfeeding – information for women and men
As indicated below, the requirements of the pregnancy prevention programme 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 baby. 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 unborn baby.
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 methods of contraception 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 at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive measures:

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

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 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 stopping treatment.
  • If the 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 stopping treatment.
Blood donation and blood tests
During treatment and for 7 days after stopping treatment, 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 for the patient:

  • 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 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 or has recently taken, as well as any medicines the patient plans to take, because Pomalidomide PPH may affect the action of other medicines. Other medicines may also 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 physician experienced in the treatment of multiple myeloma.
This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
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 administered in treatment cycles. Each cycle lasts 21 days (3 weeks).
  • Refer to 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

  • Read the package leaflet provided with dexamethasone for further information on its use and effects.
  • Pomalidomide PPH and dexamethasone are administered in treatment cycles. Each cycle lasts 28 days (4 weeks).
  • Refer to 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 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.

Your 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, overall
health status, concomitant use of other medicines (e.g. ciprofloxacin, enoxacin, and fluvoxamine), and
if treatment-related adverse effects 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 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.
  • Take the capsules 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.

Diagram showing instructions for opening a medication package, depicting fingers pressing and prying at the edge of a blister pack to remove a 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 discontinue therapy.

Accidentally taking more than the recommended dose of Pomalidomide PPH
If more than the recommended dose of Pomalidomide PPH has been taken, contact your doctor immediately or go to the 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 scheduled 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, 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 your doctor immediately – immediate
treatment may be required.

  • 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 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 lower leg and calf (due to 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, pain in the right side of the abdomen, fever, nausea and vomiting. Contact your doctor 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 any of these symptoms occur, stop taking pomalidomide immediately and contact your 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 your doctor immediately – immediate treatment may be required.
Other adverse reactions
Very common (may affect more than 1 in 10 people):

  • shortness of breath (dyspnoea)
  • lung infections (pneumonia and bronchitis)
  • infections of the nose, sinuses and throat caused by bacteria or viruses
  • 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 when passing urine or the need to pass urine more frequently

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

  • fall
  • bleeding inside 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 due to fluid accumulation
  • urticaria (hives)
  • itching of the skin
  • shingles
  • 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, have shortness of breath and be 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 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 itching of the skin, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine and abdominal pain
  • tumour lysis syndrome, which is the 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 determined 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, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 safe use of the 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 carton after EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot indicates the batch number.
No special storage conditions apply for this medicine.
Do not use this medicine if you notice any damage to or signs of tampering with the packaging.
Medicines should not be disposed of via wastewater or household waste. After treatment is completed, any unused medicine should be returned to a pharmacy that accepts such returns. 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 components 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), indigocarmine (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), indigocarmine (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 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