Pomalidomide stada

Package leaflet: Information for the patient

Pomalidomide Stada, 1 mg, hard capsules
Pomalidomide Stada, 2 mg, hard capsules
Pomalidomide Stada, 3 mg, hard capsules
Pomalidomide Stada, 4 mg, hard capsules
Pomalidomide
The medicine Pomalidomide Stada is expected to cause severe birth defects and may lead to fetal death.

• Do not take the medicine if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant.
• You must follow the contraceptive advice provided in this leaflet.

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

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

1. What Pomalidomide Stada is and what it is used for
What Pomalidomide Stada is
Pomalidomide Stada 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 Stada is used for
Pomalidomide Stada is used to treat adults with a type of cancer called multiple myeloma.
Pomalidomide Stada is used in combination with:

• two other medicines, bortezomib (a chemotherapy medicine) and dexamethasone (an anti-inflammatory medicine), in patients who have already received at least one other treatment containing lenalidomide or
• one other medicine, dexamethasone, in patients with multiple myeloma whose condition has worsened despite having previously received at least two other 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, causing damage to bones and kidneys.
Multiple myeloma is generally incurable. However, treatment may relieve the signs and symptoms of the disease or cause them to disappear for a period of time—this is known as a "response" to treatment.
How Pomalidomide Stada works
Pomalidomide Stada 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 cancer cells.

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

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

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

• Pomalidomide with dexamethasone typically delayed the progression of multiple myeloma for up to 4 months—compared to 2 months in patients who received only dexamethasone.

2. What you need to know before taking Pomalidomide Stada

When not to take Pomalidomide Stada:

• if you are allergic to pomalidomide or any of the other ingredients of this medicine listed in section 6. If you suspect an allergic reaction to the medicine, consult your doctor.
• if you are pregnant, suspect you may be pregnant, or plan to become pregnant, because Pomalidomide Stada is expected to be harmful to the unborn child (both men and women taking this medicine must read the section "Pregnancy, contraception, and breastfeeding—information for women and men" below).
• if you are capable of becoming pregnant, unless you use all necessary methods of contraception (see section "Pregnancy, contraception, and breastfeeding—information for women and men"). If you are capable of becoming pregnant, your doctor will always document that you understand all necessary contraceptive methods you must use each time the medicine is prescribed and will provide you with confirmation. If you are unsure whether any of the above situations apply to you, consult your doctor, pharmacist, or nurse before starting Pomalidomide Stada.

Warnings and precautions
Before starting Pomalidomide Stada, discuss with your doctor, pharmacist, or nurse if:

• you have ever had blood clots in the past. There is an increased risk of blood clots in veins and arteries during treatment with Pomalidomide Stada. Your doctor may prescribe additional treatment (e.g., warfarin) or reduce the dose of Pomalidomide Stada to reduce the risk of blood clots.

• you have ever had an allergic reaction such as rash, itching, swelling, dizziness, or breathing difficulties while taking similar medicines called "thalidomide" or "lenalidomide".

• you have had a heart attack, have heart failure, have breathing difficulties, or if you smoke, have high blood pressure, or high cholesterol levels.

• you have extensive tumour involvement in the body, including in the bone marrow. This may lead to a condition called tumour lysis syndrome, in which tumours break down rapidly, causing abnormal levels of chemicals in the blood, potentially leading to kidney failure. You may also experience heart rhythm disturbances.

• you have or have had neuropathy (nerve damage causing tingling or pain in hands or feet).

• you have or have had hepatitis B virus infection. Taking Pomalidomide Stada may reactivate the virus in previously infected patients, leading to a recurrence of infection. Your doctor should check whether you have been previously infected with hepatitis B virus.

• you have had or currently have any combination of the following symptoms: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, or 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 other types of cancer. Therefore, your doctor should carefully evaluate the benefits and risks of prescribing this medicine.
During or after treatment, immediately inform your doctor or nurse if you experience: vision disturbances, loss of vision, double vision, difficulty speaking, weakness in arms or legs, changes in walking or balance, persistent numbness, reduced sensation, loss of sensation, memory loss, or disorientation.
All these symptoms may indicate a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before taking Pomalidomide Stada, inform your doctor of any changes in these symptoms.
After completing treatment, you should return any unused capsules to the pharmacy.
Children and adolescents
Pomalidomide Stada is not recommended for use in children and adolescents under 18 years of age.
Pomalidomide Stada and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any you plan to take, because Pomalidomide Stada may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Stada.
Before taking Pomalidomide Stada, inform your doctor, pharmacist, or nurse, especially if you are taking any of the following medicines:

• certain antifungal medicines such as ketoconazole,
• certain antibiotics (e.g., ciprofloxacin, enoxacin),
• certain antidepressants such as fluvoxamine.

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 Stada.
Women taking Pomalidomide Stada must not become pregnant, and men taking Pomalidomide Stada must not father a child. The medicine is expected to harm the unborn child. You and your partner should use effective contraception methods during treatment with this medicine.
Women
Do not take Pomalidomide Stada if you are pregnant, suspect you may be pregnant, or plan to become pregnant, because the medicine is expected to harm the unborn child. Before starting treatment, inform your doctor if you could become pregnant, even if you consider it unlikely.
If you are capable of becoming pregnant:

• you 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. Discuss with your doctor which contraception method is best for you.
• each time the medicine is prescribed, your doctor will ensure you understand all necessary contraceptive methods you must use to prevent pregnancy.
• your doctor will order pregnancy tests before treatment, at least every 4 weeks during treatment, and for at least 4 weeks after stopping treatment.
• If you become pregnant despite using preventive methods:
• you must immediately stop treatment and inform your doctor immediately.

Breastfeeding
It is not known whether Pomalidomide Stada passes into human milk. If you are breastfeeding or plan to breastfeed, inform your doctor. Your doctor will advise you whether to stop or continue breastfeeding.
Men
Pomalidomide Stada passes into human semen.

• If your partner is pregnant or could become pregnant, you must use condoms throughout the entire treatment period and for 7 days after stopping treatment.
• If your partner becomes pregnant while you are being treated with Pomalidomide Stada, inform your doctor immediately. Your partner should also seek immediate medical advice.

You must not donate sperm or semen during treatment and for 7 days after stopping treatment.
Blood donation and blood tests
During treatment and for 7 days after stopping treatment, you must not donate blood.
Before and during treatment with Pomalidomide Stada, you will have regular blood tests. This is because the medicine may reduce the number of blood cells (white blood cells) that help fight infections and the number of cells (platelets) that help stop bleeding.
Your doctor should schedule blood tests:

• before treatment,
• weekly during the first 8 weeks of treatment,
• thereafter at least once a month for as long as you are taking Pomalidomide Stada.

Your doctor may adjust the dose of Pomalidomide Stada or discontinue treatment based on your blood test results. Your doctor may also adjust the dose or stop treatment due to your overall health condition.
Driving and using machines
While taking Pomalidomide Stada, some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness. If you experience any of these symptoms, do not drive, use tools, or operate machinery.
Pomalidomide Stada contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicinal product is considered "sodium-free".
Pomalidomide Stada contains isomalt
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Pomalidomide Stada

Pomalidomide Stada must be prescribed by a doctor experienced in the treatment of
multiple myeloma.
This medicine should always be taken exactly as prescribed by the doctor. If in doubt,
consult the doctor, pharmacist, or nurse.
When to take Pomalidomide Stada with other medicines
Pomalidomide Stada with bortezomib and dexamethasone

• Refer to the package leaflets for bortezomib and dexamethasone for further information regarding their use and effects.
• Pomalidomide Stada, bortezomib, and dexamethasone are administered in treatment cycles. Each cycle lasts 21 days (3 weeks).
• The table below helps to determine which medicines should be taken on each day of the 3-week cycle:
  • Each day, locate the corresponding day in the table and check which medicines need to be taken.
  • On some days, all 3 medicines are taken; on other days, only 2 or 1 medicine is taken, and on some days, no medicines are taken.

POM: Pomalidomide (Pomalidomide Stada); BOR: bortezomib; DEX: dexamethasone
Cycles 1 to 8 Cycle 9 and onwards

After completing each 3-week cycle, a new cycle should be started.
Pomalidomide Stada with dexamethasone only

• Please refer to the package leaflet of dexamethasone for further information on its use and effects.
• Pomalidomide Stada and dexamethasone are administered in treatment cycles. Each cycle lasts 28 days (4 weeks).
• The table below helps you determine which medicines to take on specific days of the 4-week cycle:
  • Each day, locate the corresponding day in the table and check which medicines should be taken.
  • On some days, both medicines should be taken; on other days, only one medicine or no medicine at all.

POM: Pomalidomide (Pomalidomide Stada); DEX: dexamethasone

After completion of each 4-week cycle, a new cycle should be started.
What dose of Pomalidomide Stada should be taken with other medicines
Pomalidomide Stada with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Stada 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 Stada with dexamethasone alone

• The recommended dose of Pomalidomide Stada 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 Stada, bortezomib, or dexamethasone, or
discontinue treatment with one or more of these medicines depending on the patient's blood test results,
overall health condition, use of other medicines (e.g. ciprofloxacin, enoxacin, and
fluvoxamine), and if treatment-related adverse reactions occur
(particularly rash and 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 Stada

• Do not crush, open, or chew the capsules. If the powder from a damaged Pomalidomide Stada 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.
• Pomalidomide Stada 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 problems and is on dialysis, the doctor will advise how and when to take Pomalidomide Stada.
Duration of treatment with Pomalidomide Stada
Treatment cycles should be continued until the doctor decides to discontinue treatment.
Taking more Pomalidomide Stada than prescribed
If a patient takes more than the prescribed dose of Pomalidomide Stada, they should immediately inform their doctor or go to a hospital. The patient should bring the medicine packaging with them.
Missing a dose of Pomalidomide Stada
If a patient misses a dose of Pomalidomide Stada on the day it should have been taken, they should take the next capsule at the usual time on the following day. Do not take a double dose to make up for the missed Pomalidomide Stada capsule.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

Serious adverse effects
If any of the following serious adverse effects occur, stop taking Pomalidomide Stada 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 a lower number 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, 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 (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 difficulty breathing (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 you notice any skin changes while taking Pomalidomide Stada, report this to your doctor as quickly as possible.
• Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and whites of the eyes, dark urine, pain on the right side of the abdomen, fever, nausea and vomiting. Seek medical advice immediately if you notice these symptoms.
• 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, stop taking pomalidomide immediately and contact your doctor or seek urgent medical help. See also section 2.

If any of the above serious adverse effects occur, stop taking Pomalidomide Stada immediately and contact your doctor straight away – immediate treatment may be necessary.

Other adverse effects

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).
• Decrease in red blood cells, which may lead 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 levels of sugar in the blood.
• 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 (oedema).
• Rash.
• Urinary tract infection, which may cause burning when passing urine or a need to pass urine more frequently.

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

• Falling.
• 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 (paraesthesiae).
• A spinning sensation in the head, making it difficult to maintain proper standing posture and movement.
• Swelling due to fluid accumulation.
• Urticaria (hives).
• Itching of the skin.
• Shingles (herpes zoster).
• Heart attack (chest pain spreading to arms, neck, jaw, accompanied by sweating and shortness of breath, nausea or vomiting).
• Chest pain, infection in the chest area.
• Increased blood pressure.
• Simultaneous reduction in red blood cells, white blood cells and platelets (pancytopenia), making the patient more susceptible to bleeding and bruising. The patient may feel tired, weak and short of breath. The patient is also more prone to infections.
• Decrease in lymphocytes (a type of white blood cell), often caused by 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), which may cause numbness and/or tingling in hands, feet or lips, muscle cramps, muscle weakness, pre-syncope, confusion.
• Low levels of phosphates 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, which may cause abnormal heart rhythm.
• Low levels of sodium in the blood, 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.
• 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 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 the available data):

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

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects 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
PL-02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Pomalidomide Stada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP or "Termin ważności (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 Stada if you notice any damage or signs of tampering with the packaging.
Medicines should not be disposed of via wastewater or household waste. At the end of treatment, any unused medicine should be returned to a pharmacist. This will help protect the environment.

6. Contents of the pack and other information

What Pomalidomide Stada contains

• The active substance is pomalidomide.
• The other ingredients are isomalt 801 (E953), isomalt 721 (E953), pregelatinized corn starch, and sodium stearyl fumarate.

Pomalidomide Stada 1 mg hard capsule:

• Each hard capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and black printing ink.

Pomalidomide Stada 2 mg hard capsule:

• Each hard capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and black printing ink.

Pomalidomide Stada 3 mg hard capsule:

• Each hard capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), and black printing ink.

Pomalidomide Stada 4 mg hard capsule:

• Each hard capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), erythrosine (E127), and black printing ink.

The printing ink contains: shellac (E904), concentrated ammonium hydroxide, potassium hydroxide, and black iron oxide (E172).

What Pomalidomide Stada looks like and contents of the pack

Pomalidomide Stada 1 mg hard capsules
Yellow, opaque cap and yellow, opaque body, capsule size No. 4 (approx. 14 mm x 5 mm), printed in black ink with "LP" on the cap and "664" on the body, containing yellow, granular powder.

Pomalidomide Stada 2 mg hard capsules
Orange, opaque cap and orange, opaque body, capsule size No. 3 (approx. 16 mm x 6 mm), printed in black ink with "LP" on the cap and "665" on the body, containing yellow, granular powder.

Pomalidomide Stada 3 mg hard capsules
Opaque powder-blue cap and opaque powder-blue body, capsule size No. 2 (approx. 18 mm x 6 mm), printed in black ink with "LP" on the cap and "690" on the body, containing yellow, granular powder.

Pomalidomide Stada 4 mg hard capsules
Blue, opaque cap and blue, opaque body, capsule size No. 2 (approx. 18 mm x 6 mm), printed in black ink with "LP" on the cap and "667" on the body, containing yellow, granular powder.

Pack sizes:
Blister packs made of PVC/PCTFE/Aluminum or OPA/Aluminum/PVC/Aluminum, in a cardboard box:
14 hard capsules (standard blisters)
14 x 1 hard capsule (perforated single-dose blisters)
21 hard capsules (standard blisters)
21 x 1 hard capsule (perforated single-dose blisters).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Qualimetrix S.A.
Mesogeion Avenue 579
Agia Paraskevi
153 43 Athens
Greece
Adalvo Limited
Malta Life Sciences Park Building 1 Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate
SGN 3000 San Gwann
Malta
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000 Paola
Malta
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Clonmel Healthcare Limited
Waterford Road
E91 D768 Clonmel, Co. Tipperary
Ireland

For further information, please contact the representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised for sale in the European Economic Area under the following names:

Austria
Pomalidomid STADA 1 mg Hartkapseln
Pomalidomid STADA 2 mg Hartkapseln
Pomalidomid STADA 3 mg Hartkapseln
Pomalidomid STADA 4 mg Hartkapseln

Belgium
Pomalidomide EG 1 mg harde capsules
Pomalidomide EG 2 mg harde capsules
Pomalidomide EG 3 mg harde capsules
Pomalidomide EG 4 mg harde capsules

Cyprus
Pomalidomide Stada

Denmark
Pomalidomide STADA

Estonia
Pomalidomide STADA

Finland
Pomalidomide STADA 1 mg kapselit, kovat
Pomalidomide STADA 2 mg kapselit, kovat
Pomalidomide STADA 3 mg kapselit, kovat
Pomalidomide STADA 4 mg kapselit, kovat

France
POMALIDOMIDE EG 1 mg, gélule
POMALIDOMIDE EG 2 mg, gélule
POMALIDOMIDE EG 3 mg, gélule
POMALIDOMIDE EG 4 mg, gélule

Greece
Pomalidomide/Stada

Spain
Pomalidomida STADA 1 mg cápsulas duras EFG
Pomalidomida STADA 2 mg cápsulas duras EFG
Pomalidomida STADA 3 mg cápsulas duras EFG
Pomalidomida STADA 4 mg cápsulas duras EFG

Netherlands
Pomalidomide CF 1 mg, harde capsules
Pomalidomide CF 2 mg, harde capsules
Pomalidomide CF 3 mg, harde capsules
Pomalidomide CF 4 mg, harde capsules

Ireland
Pomalidomide Clonmel 1 mg hard capsules
Pomalidomide Clonmel 2 mg hard capsules
Pomalidomide Clonmel 3 mg hard capsules
Pomalidomide Clonmel 4 mg hard capsules

Iceland
Pomalidomide STADA 1 mg hörð hylki
Pomalidomide STADA 2 mg hörð hylki
Pomalidomide STADA 3 mg hörð hylki
Pomalidomide STADA 4 mg hörð hylki

Lithuania
Pomalidomide STADA 1 mg kietosios kapsulės
Pomalidomide STADA 2 mg kietosios kapsulės
Pomalidomide STADA 3 mg kietosios kapsulės
Pomalidomide STADA 4 mg kietosios kapsulės

Luxembourg
Pomalidomide EG 1 mg gélules
Pomalidomide EG 2 mg gélules
Pomalidomide EG 3 mg gélules
Pomalidomide EG 4 mg gélules

Latvia
Pomalidomide STADA 1 mg cietās kapsulas
Pomalidomide STADA 2 mg cietās kapsulas
Pomalidomide STADA 3 mg cietās kapsulas
Pomalidomide STADA 4 mg cietās kapsulas

Malta
Pomalidomide Clonmel 1 mg hard capsules
Pomalidomide Clonmel 2 mg hard capsules
Pomalidomide Clonmel 3 mg hard capsules
Pomalidomide Clonmel 4 mg hard capsules

Germany
Pomalidomid AL 1 mg Hartkapseln
Pomalidomid AL 2 mg Hartkapseln
Pomalidomid AL 3 mg Hartkapseln
Pomalidomid AL 4 mg Hartkapseln

Norway
Pomalidomide STADA

Poland
Pomalidomide Stada

Portugal
Pomalidomida Stada

Romania
Pomalidomidă Stada 1 mg capsule
Pomalidomidă Stada 2 mg capsule
Pomalidomidă Stada 3 mg capsule
Pomalidomidă Stada 4 mg capsule

Slovakia
Pomalidomid STADA 1/2/3/4 mg tvrdé kapsuly

Slovenia
Pomalidomid STADA 1 mg trde kapsule
Pomalidomid STADA 2 mg trde kapsule
Pomalidomid STADA 3 mg trde kapsule
Pomalidomid STADA 4 mg trde kapsule

Sweden
Pomalidomide STADA 1 mg hårda kapslar
Pomalidomide STADA 2 mg hårda kapslar
Pomalidomide STADA 3 mg hårda kapslar
Pomalidomide STADA 4 mg hårda kapslar

Hungary
Pomalidomide Stada 1 mg kemény kapszula
Pomalidomide Stada 2 mg kemény kapszula
Pomalidomide Stada 3 mg kemény kapszula
Pomalidomide Stada 4 mg kemény kapszula

Italy
Pomalidomide EG