POMALIDOMIDE OLPHA

Package leaflet: Information for the patient

Pomalidomide Olpha, 1 mg, hard capsules
Pomalidomide Olpha, 2 mg, hard capsules
Pomalidomide Olpha, 3 mg, hard capsules
Pomalidomide Olpha, 4 mg, hard capsules
Pomalidomide
Pomalidomide Olpha is expected to cause severe birth defects and may result in 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 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

What Pomalidomide Olpha is
Pomalidomide Olpha 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 Olpha is used for
Pomalidomide Olpha is used to treat adults with a type of cancer called multiple myeloma.
Pomalidomide Olpha 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 progressed despite having previously received at least two 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, leading to bone and kidney damage.
Multiple myeloma is generally considered incurable. However, treatment may relieve symptoms or cause the disease to go into remission for a period of time – this is called a response to treatment.
How Pomalidomide Olpha works
Pomalidomide Olpha 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 Olpha with bortezomib and dexamethasone
Pomalidomide Olpha, 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 Olpha used 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 Olpha with dexamethasone
Pomalidomide Olpha, 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 Olpha used with dexamethasone typically delayed the recurrence of multiple myeloma for up to 4 months – compared to 2 months in patients who received only dexamethasone.

2. Important information before using Pomalidomide Olpha

When not to take Pomalidomide Olpha:

• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because Pomalidomide Olpha 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 necessary 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 confirm this with the patient.
• if the patient has an allergy 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 Olpha.
Warnings and precautions
Before starting treatment with Pomalidomide Olpha, discuss with the doctor,
pharmacist, or nurse if:

• the patient has ever had blood clots in the past. Treatment with Pomalidomide Olpha 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 Olpha to lower the risk of blood clots.
• the patient has ever experienced hypersensitivity reactions 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 syndrome, where tumours break down rapidly, causing abnormal levels of 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 hands or feet).
• the patient has or has had hepatitis B virus infection. Taking Pomalidomide Olpha may reactivate the virus in previously infected patients, leading to a 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").

It should be noted that patients with multiple myeloma treated with pomalidomide may develop additional types of tumours. Therefore, the doctor should carefully assess the benefits and risks associated with prescribing this medicine to the patient.
At any time during or after completion of treatment, 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 these symptoms may indicate a serious and potentially life-threatening brain disorder
called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before
treatment with Pomalidomide Olpha, inform the doctor of any changes in these
symptoms.
After treatment ends, return any unused capsules to a pharmacy that accepts them.
Pregnancy, contraception and breastfeeding – information for women and men
As indicated below, pregnancy prevention programme requirements must be followed
during treatment with Pomalidomide Olpha. Women taking Pomalidomide Olpha must not
become pregnant, and men being treated with pomalidomide must not allow their partner to 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 take Pomalidomide Olpha if the patient is pregnant, suspects she may be
pregnant, or plans to become pregnant, 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 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 confirm 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 Olpha passes into human milk. If the patient is breastfeeding
or intends to breastfeed, she must inform the doctor. The doctor will advise the patient whether
she should stop or continue breastfeeding.
Men
Pomalidomide Olpha 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 being treated with Pomalidomide Olpha becomes pregnant, inform the doctor immediately. The partner should seek medical advice without delay.

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 Olpha, regular blood tests will be performed.
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,
• thereafter at least once a month for as long as the patient is taking Pomalidomide Olpha.

The doctor may adjust the dose of Pomalidomide Olpha 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 overall health status.
Children and adolescents
Pomalidomide Olpha is not recommended for use in children and adolescents under 18 years of age.
Pomalidomide Olpha 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 Olpha may affect the action of other medicines.
Other medicines may also affect the action of Pomalidomide Olpha.
Before taking Pomalidomide Olpha, 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 Olpha, 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 Olpha contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should
consult a doctor before taking this medicine.
Pomalidomide Olpha contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Pomalidomide Olpha

Pomalidomide Olpha must be prescribed by a doctor experienced in the treatment of multiple myeloma.
This medicine should always be taken exactly as recommended by the doctor. In case of any doubts,
consult the doctor, pharmacist, or nurse.

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

• Read the package leaflets included with bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Olpha, 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:
  o Each day, check the table to see which medicines to take on that day.
  o On some days, all three medicines should be taken; on other days, only two or one medicine, or no medicine at all.

POM: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone

• After completion of each 3-week cycle, a new cycle should be started.

Pomalidomide Olpha with dexamethasone only

• Refer to the package leaflet of dexamethasone for further information regarding its use and effects.
• Pomalidomide Olpha and dexamethasone are administered in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Refer to the table below to determine which medications should be taken on specific days of the 4-week cycle:
  o Each day, check the table to see which medications should be taken on that day.
  o On some days, both medications should be taken; on other days, only one medication or no medication at all.

POM: Pomalidomide; DEX: Dexamethasone

• After completion of each 4-week cycle, a new cycle should be started.

What dose of Pomalidomide Olpha should be taken with other medicines

Pomalidomide Olpha with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Olpha 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 Olpha with dexamethasone only

• The recommended dose of Pomalidomide Olpha 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 Olpha, 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 treatment-related adverse reactions occur
(particularly rash or swelling).
If the patient has liver or kidney disease, the doctor will closely monitor the patient's health
during treatment with this medicine.
How to take Pomalidomide Olpha

• Do not break, open, or chew the capsules. If powder from a damaged capsule comes into contact with the skin, the skin should be washed 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 thoroughly washed 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.

If the patient has kidney disease and is on dialysis, the doctor will advise how and when to take
Pomalidomide Olpha.
Duration of treatment with Pomalidomide Olpha
Treatment cycles should be continued until the doctor decides to discontinue treatment.
Taking more Pomalidomide Olpha than prescribed
If more than the prescribed dose of Pomalidomide Olpha has been taken, contact a doctor immediately
or go to a hospital. Take the medicine packaging with you.
Missing a dose of Pomalidomide Olpha
If the patient misses a dose of Pomalidomide Olpha on the day it should have been taken,
the next capsule should be taken at the usual time on the following day. Do not take a double dose
to make up for a missed capsule of Pomalidomide Olpha.
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, treatment with Pomalidomide Olpha must be discontinued and medical advice must be sought immediately – immediate treatment may be required:

• Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to reduced numbers of white blood cells, which help fight infection).
• Bleeding or bruising without cause, including nosebleeds, or bleeding from the intestines or stomach (due to the medicine's effect 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 diarrhoea (also with abdominal pain or fever) caused by bacteria called Clostridium difficile.
• Chest pain or leg pain and swelling, particularly in the calf or lower leg (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, possibly causing 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 Olpha, this should be reported to the 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, pain in the right side of the abdomen, 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 reaction 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, pomalidomide must be stopped immediately and medical advice must be sought urgently. See also section 2.

If any of the above serious adverse reactions occur, treatment with Pomalidomide Olpha must be discontinued and medical advice must be sought 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).
• Bacterial or viral infections of the nose, sinuses and throat.
• Flu-like symptoms (influenza).
• Decreased number of red blood cells, possibly leading to anaemia causing fatigue and weakness.
• Low blood potassium levels (hypokalaemia), possibly causing 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, possibly causing burning during urination or increased frequency of urination.

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

• Falls.
• 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 (paraesthesiae).
• 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 (herpes zoster).
• Heart attack (chest pain spreading to arms, neck, jaw, sensation of sweating and shortness of breath, nausea or vomiting).
• Chest pain, infection in the chest area.
• High blood pressure.
• Simultaneous decrease 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.
• Decreased number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia).
• Low blood magnesium levels (hypomagnesaemia), possibly causing fatigue, generalised weakness, muscle cramps, irritability and leading 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), possibly causing muscle weakness, irritability or confusion.
• High blood calcium levels (hypercalcaemia), possibly causing slowed reflexes and skeletal muscle weakness.
• High blood potassium levels, possibly causing irregular heart rhythm.
• Low blood sodium levels, possibly causing 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, possibly causing 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. 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 (cannot be estimated from available data):

• Rejection of a solid organ transplant (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 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Pomalidomide Olpha

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack following: EXP or Expiry date (EXP). The expiry date refers to the last day of the
specified month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. After
treatment has ended, unused medicines should be returned to a pharmacy which will
accept them. This will help protect the environment.

6. Contents of the pack and other information

What Pomalidomide Olpha contains

• The active substance is pomalidomide.
• The other ingredients are microcrystalline cellulose, pregelatinized starch, sucrose and sodium stearyl fumarate. The printing ink (black) contains shellac (E904), propylene glycol (E 1520), black iron dioxide (E 172), potassium hydroxide (E525) and concentrated ammonia solution.

Pomalidomide Olpha, 1 mg, hard capsules (capsules)

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E 171) and gelatin.

Pomalidomide Olpha, 2 mg, hard capsules (capsules)

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E 171), gelatin, red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172).

Pomalidomide Olpha, 3 mg, hard capsules (capsules)

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E 171), gelatin, red iron oxide (E 172).

Pomalidomide Olpha, 4 mg, hard capsules (capsules)

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: titanium dioxide (E 171) and gelatin.

What Pomalidomide Olpha looks like and contents of the pack
Pomalidomide Olpha 1 mg, hard capsules
Hard gelatin capsule, 10.7 – 11.5 mm in length (size 5) with a white, opaque cap and a white, opaque body, printed with “H” on the cap and “P6” on the body, filled with powder ranging from pale yellow to yellowish, free from physical defects.
Pomalidomide Olpha 2 mg, hard capsules
Hard gelatin capsule, 13.9 – 14.7 mm in length (size 4) with a white, opaque cap and a brown, opaque body, printed with “H” on the cap and “P7” on the body, filled with powder ranging from pale yellow to yellowish, free from physical defects.
Pomalidomide Olpha 3 mg, hard capsules
Hard gelatin capsule, 15.3 – 16.1 mm in length (size 3) with a white, opaque cap and a pink, opaque body, printed with “H” on the cap and “P8” on the body, filled with powder ranging from pale yellow to yellowish, free from physical defects.
Pomalidomide Olpha 4 mg, hard capsules
Hard gelatin capsule, 17.2 – 18.0 mm in length (size 2) with a white, opaque cap and a white, opaque body, printed with “H” on the cap and “P9” on the body, filled with powder ranging from pale yellow to yellowish, free from physical defects.
Capsules are packed in PVC/Aluminium/OPA/Aluminium blisters containing 14 and 21 hard capsules, and in single-dose perforated blisters containing 14 x 1 and 21 x 1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]

Manufacturer
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park, Paola,
PLA 3000,
Malta

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Finland, Germany, Italy,
Poland, Estonia, Czech Republic: Pomalidomide Olpha
Spain: Pomalidomida Olpha 1 mg, 2 mg, 3 mg, 4 mg cápsulas duras EFG
France: POMALIDOMIDE OLPHA 1 mg, 2 mg, 3 mg, 4 mg, gélule
Latvia: Pomalidomide Olpha 1 mg, 2 mg, 3 mg, 4 mg cietās kapsulas
Lithuania: Pomalidomide Olpha 1 mg, 2 mg, 3 mg, 4 mg kietos kapsulės
Slovakia: Pomalidomide Olpha 1 mg, 2 mg, 3 mg, 4 mg tvrdé kapsuly