Pomalidomide eugia

Package leaflet: Information for the patient

Pomalidomide Eugia, 1 mg, hard capsules
Pomalidomide Eugia, 2 mg, hard capsules
Pomalidomide Eugia, 3 mg, hard capsules
Pomalidomide Eugia, 4 mg, hard capsules
Pomalidomide
Pomalidomide Eugia 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 further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, 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.

Contents of the leaflet

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

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

Pomalidomide Eugia 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 Eugia is used for
Pomalidomide Eugia is used to treat adults with a type of cancer called multiple myeloma.
Pomalidomide Eugia 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 prior 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.
Multiple myeloma is generally considered incurable. However, treatment may relieve symptoms and signs of the disease or induce a temporary remission. This is known as a response to treatment.

How Pomalidomide Eugia works
Pomalidomide Eugia 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 nutrients

Benefits of Pomalidomide Eugia with bortezomib and dexamethasone
Pomalidomide Eugia, when used in combination with bortezomib and dexamethasone in patients who have previously received at least one other treatment, can delay the progression of multiple myeloma:

• Pomalidomide Eugia combined with bortezomib and dexamethasone typically delayed the recurrence of multiple myeloma for up to 11 months – compared to 7 months in patients receiving only bortezomib and dexamethasone.

Benefits of Pomalidomide Eugia with dexamethasone
Pomalidomide Eugia, when used in combination with dexamethasone in patients who have previously received at least two other treatments, can delay the progression of multiple myeloma:

• Pomalidomide Eugia combined with dexamethasone typically delayed the recurrence of multiple myeloma for up to 4 months – compared to 2 months in patients receiving only dexamethasone.

2. Important information before taking Pomalidomide Eugia

When not to take Pomalidomide Eugia

• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because Pomalidomide Eugia 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 appropriate measures have been taken and will ensure the patient is aware of this.
• if the patient has hypersensitivity to pomalidomide or any of the other ingredients of this medicine listed in section 6. If an allergic reaction to the medicine is suspected, medical advice should be sought.

If the patient is unsure whether any of the above situations apply, please consult a doctor, pharmacist, or nurse before starting treatment with Pomalidomide Eugia.

Warnings and precautions

Before starting treatment with Pomalidomide Eugia, discuss with the doctor, pharmacist, or nurse if:

• the patient has ever had blood clots in the past. Treatment with Pomalidomide Eugia 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 Eugia to lower the risk of blood clots.

• the patient has ever experienced a hypersensitivity reaction such as rash, itching, swelling, dizziness, or difficulty breathing while taking similar medicines called "thalidomide" or "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 syndrome, in which tumours break down rapidly, causing abnormal levels of chemicals in the blood, potentially leading to kidney failure. The patient may also experience irregular heartbeats. 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 Eugia 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").

It should be emphasized that patients with multiple myeloma treated with pomalidomide may develop additional types of cancer. Therefore, the doctor should carefully evaluate the benefits and risks associated with prescribing this medicine.

During or after treatment, immediately inform the doctor or nurse if any of the following symptoms occur: vision disturbances, loss of vision, 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 these symptoms may indicate a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before starting Pomalidomide Eugia, inform the doctor of any changes in these symptoms.

After treatment ends, return any unused capsules to the pharmacy.

Pregnancy, contraception and breastfeeding – information for women and men

As indicated below, the conditions of the pregnancy prevention programme must be followed during treatment with Pomalidomide Eugia. Women taking Pomalidomide Eugia 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 must use effective contraception methods during treatment with this medicine.

Women

Do not take Pomalidomide Eugia 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 that she could become pregnant, even if she considers it unlikely.

If the patient could become pregnant:

• must use effective contraception methods for at least 4 weeks before starting treatment, throughout the treatment period, and for at least 4 weeks after treatment ends. The patient should discuss with the doctor which contraception method is best suited 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, every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive measures:

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

Breastfeeding

It is unknown whether Pomalidomide Eugia passes into human milk. If the patient is breastfeeding or plans to breastfeed, she must inform the doctor. The doctor will advise whether she should stop or continue breastfeeding.

Men

Pomalidomide Eugia 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 being treated with Pomalidomide Eugia becomes pregnant, inform the doctor immediately. The partner should seek medical advice promptly.

The patient must not donate sperm or semen 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 Eugia, the doctor will regularly order blood tests. This is 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
• thereafter at least once a month for as long as the patient is taking Pomalidomide Eugia.

The doctor may adjust the dose of Pomalidomide Eugia or interrupt treatment based on the results of blood tests. The doctor may also change the dose or discontinue treatment due to the patient's overall health condition.

Children and adolescents

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

Pomalidomide Eugia 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 Eugia may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Eugia.

Before taking Pomalidomide Eugia, 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 Eugia, some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness. If such symptoms occur, the patient should not drive, operate tools, or use machinery.

Pomalidomide Eugia contains sodium, maltitol and isomalt

Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

Maltitol and isomalt: If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to take Pomalidomide Eugia

Pomalidomide Eugia 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 you have any doubts, consult
your doctor, pharmacist, or nurse.

When to take Pomalidomide Eugia with other medicines

Pomalidomide Eugia with bortezomib and dexamethasone

• Refer to the package leaflets for bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Eugia, 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 are taken; on other days, only two or one medicine is taken; on some days, no medicines are taken.

POM: Pomalidomide Eugia; BOR: bortezomib; DEX: dexamethasone
Cycles 1 to 8 Cycle 9 and onwards
Medicine Medicine
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 Eugia with dexamethasone only

• Refer to the package leaflet for dexamethasone for further information on its use and effects.
• Pomalidomide Eugia 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 are taken; on other days, only one medicine is taken; on some days, no medicines are taken.

POM: Pomalidomide Eugia; DEX: dexamethasone
Medicine
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 Eugia should be taken with other medicines

Pomalidomide Eugia with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Eugia is 4 mg once daily.
• The recommended starting dose of bortezomib will be determined by your doctor based on your 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 Eugia with dexamethasone only

• The recommended dose of Pomalidomide Eugia 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 Eugia, bortezomib, or dexamethasone, or discontinue treatment with one or more of these medicines depending on blood test results, the patient’s general health, 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 doctor will closely monitor the patient’s health during treatment with this medicine.

How to take Pomalidomide Eugia

• 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 capsules. 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 capsules.
• 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 in 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 Eugia.

Duration of treatment with Pomalidomide Eugia
Continue treatment cycles until your doctor decides to stop treatment.

Taking more Pomalidomide Eugia than prescribed
If you take more Pomalidomide Eugia than prescribed, contact your doctor immediately or go to the hospital. Take the medicine packaging with you.

Missing a dose of Pomalidomide Eugia
If you miss a dose of Pomalidomide Eugia 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 capsule of Pomalidomide Eugia.

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 Eugia
immediately and contact your doctor straight away – immediate treatment may be necessary:

• 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).
• Unexplained bleeding or bruising, including nosebleeds, or bleeding from the intestines or stomach (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, particularly in the calf or shin (due to blood clots).
• Shortness of breath (due to severe chest infections, pneumonia, heart failure or blood clots).
• Swelling of the face, lips, tongue or throat, possibly causing breathing difficulties (due to serious 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 Eugia, 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 on 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 Eugia
immediately and contact your doctor straight away – 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.
• Influenza-like symptoms (flu).
• Decreased number of red blood cells, possibly leading to anaemia causing fatigue and weakness.
• Low levels of potassium in the blood (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).
• Body swelling, including swelling of hands and feet.
• Rash.
• Urinary tract infection, which may cause burning during urination or a need to urinate more frequently.

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

• Fainting.
• 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 (oedema).
• Urticaria (hives).
• 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.
• Increased 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 due to infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, irritability and may lead to low levels of calcium in the blood (hypocalcaemia), causing numbness and/or tingling in hands, feet or lips, muscle cramps, muscle weakness, feeling of emptiness in the head, confusion.
• Low levels of phosphate in the blood (hypophosphataemia), which may cause muscle weakness, irritability or confusion.
• High levels of calcium in the blood (hypercalcaemia), which may cause slowed reflexes and skeletal muscle weakness.
• High levels of potassium in the blood (hyperkalaemia), which may cause irregular heartbeat.
• Low levels of sodium in the blood (hyponatraemia), which may cause fatigue and confusion, muscle twitching, seizures (epileptic fits) or coma.
• High levels of uric acid in the blood, 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 swelling.
• Confusion.
• Depression.
• Loss of consciousness, fainting.
• Clouding of the eye (cataract).
• Kidney damage.
• Inability to pass urine.
• Abnormal liver function test results.
• Pelvic pain.
• Weight loss.
• Increased alanine aminotransferase activity.

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 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.
• Basal cell carcinoma.

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

• Rejection of a transplanted solid organ (such as heart or liver).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can 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 provide more information on the safety of this medicine.

5. How to store Pomalidomide Eugia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard box
after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Do not use Pomalidomide Eugia if you notice any damage or signs of tampering
with the packaging of this medicine.
Medicines must not be disposed of via wastewater or household waste.
After treatment has ended, any unused medicine should be returned to a pharmacy.
This will help protect the environment.

6. Contents of the pack and other information

What Pomalidomide Eugia contains

• The active substance is pomalidomide.

Each hard capsule contains 1 mg of pomalidomide.
Each hard capsule contains 2 mg of pomalidomide.
Each hard capsule contains 3 mg of pomalidomide.
Each hard capsule contains 4 mg of pomalidomide.
The other ingredients are maltitol, isomalt, crospovidone, and sodium stearyl fumarate.
Capsule cap: indigo carmine (E 132) (for doses 1 mg, 2 mg, 3 mg), titanium dioxide (E 171),
gelatin, and iron oxide red (for dose 4 mg).
Capsule body: titanium dioxide (E 171), gelatin, indigo carmine (E 132) (for dose 3 mg), iron
oxide red (E 172) (for doses 2 mg and 4 mg), iron oxide yellow (E 172) (for doses 1 mg, 2 mg,
and 3 mg).
Printing ink (black and white): shellac, iron oxide black (E 172) (for dose 4 mg), potassium
hydroxide, and titanium dioxide (E 171) (for doses 1 mg, 2 mg, 3 mg).

What Pomalidomide Eugia looks like and contents of the pack
Pomalidomide Eugia 1 mg, hard capsules:
Hard gelatin capsule size 3, filled with yellow powder, with a dark blue, opaque cap printed in white with "P1" and a yellow, smooth, opaque body.

Pomalidomide Eugia 2 mg, hard capsules:
Hard gelatin capsule size 1, filled with yellow powder, with a dark blue, opaque cap printed in white with "P2" and an orange, smooth, opaque body.

Pomalidomide Eugia 3 mg, hard capsules:
Hard gelatin capsule size 1, filled with yellow powder, with a dark blue, opaque cap printed in white with "P3" and a green, smooth, opaque body.

Pomalidomide Eugia 4 mg, hard capsules:
Hard gelatin capsule size 0, filled with yellow powder, with a red, opaque cap printed in black with "P4" and a red, smooth, opaque body.

Pomalidomide Eugia hard capsules are available in blisters containing 14 and 21 hard capsules, and in perforated unit-dose blisters containing 14 × 1 and 21 × 1 hard capsules, packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation Holder:
Eugia Pharma (Malta) Limited
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Pomalidomide Eugia 1mg, 2mg, 3mg, 4mg harde capsules / gélules / Hartkapseln
Luxembourg: Pomalidomide Eugia 1mg, 2mg, 3mg, 4mg gélules / Hartkapseln
France: POMALIDOMIDE EUGIA 1 mg, gélule
POMALIDOMIDE EUGIA 2 mg, gélule
POMALIDOMIDE EUGIA 3 mg, gélule
POMALIDOMIDE EUGIA 4 mg, gélule
Germany: Pomalidomid PUREN 1mg, 2mg, 3mg, 4mg, Hartkapseln
Italy: Pomalidomide Aurobindo
Netherlands: Pomalidomide Eugia 1 mg, harde capsules
Pomalidomide Eugia 2 mg, harde capsules
Pomalidomide Eugia 3 mg, harde capsules
Pomalidomide Eugia 4 mg, harde capsules
Poland: Pomalidomide Eugia
Portugal: Pomalidomida Eugia
Spain: Pomalidomida Eugia 3 mg cápsulas duras EFG
Pomalidomida Eugia 4 mg cápsulas duras EFG