Pomalidomide EG
Italy
Table of Contents
- Patient Information Leaflet
- Pomalidomide EG 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
- 1. What Pomalidomide EG is and what it is used for
- 2. What you need to know before taking Pomalidomide EG
- 3. How to take Pomalidomide EG
- 4. Possible side effects
- 5. How to store Pomalidomide EG
- 6. Package contents and other information
Patient Information Leaflet
Pomalidomide EG 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
Equivalent medicine
Pomalidomide EG is expected to cause birth defects and may result in fetal death.
- Do not take this medicine if you are pregnant or could become pregnant.
- Follow the advice on contraceptive methods described in this leaflet.
Read this entire leaflet carefully before taking this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
- What Pomalidomide EG is and what it is used for
- What you need to know before taking Pomalidomide EG
- How to take Pomalidomide EG
- Possible side effects
- How to store Pomalidomide EG
- Contents of the pack and other information
1. What Pomalidomide EG is and what it is used for
What Pomalidomide EG is
Pomalidomide EG contains the active substance "pomalidomide". This medicine is related to thalidomide and belongs to a group of medicines that act on the immune system (the body's natural defenses).
What Pomalidomide EG is used for
Pomalidomide EG is used to treat adults with a type of cancer called "multiple myeloma".
Pomalidomide EG is used in combination with:
- two other medicines, called "bortezomib" (a type of chemotherapy medicine) and "dexamethasone" (an anti-inflammatory medicine), in patients who have received at least one other treatment including lenalidomide. Or
- one other medicine, called "dexamethasone", in patients whose myeloma has worsened despite at least two previous treatments including lenalidomide and bortezomib.
What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells (called "plasma cells"). These cells grow uncontrollably and accumulate in the bone marrow. This causes damage to the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce the signs and symptoms of the disease or make them disappear for a certain period of time. When this occurs, it is referred to as a "response".
How Pomalidomide EG works
Pomalidomide EG works in several ways:
- by stopping the growth of myeloma cells;
- by stimulating the immune system to attack cancer cells;
- by inhibiting the formation of blood vessels that supply nutrients to cancer cells.
Benefit of using Pomalidomide EG together with bortezomib and dexamethasone
When Pomalidomide EG is used together with bortezomib and dexamethasone in patients who have received at least one prior treatment, it can prevent multiple myeloma from worsening:
- On average, pomalidomide used with bortezomib and dexamethasone delayed the progression of multiple myeloma for up to 11 months, compared to 7 months in patients treated with bortezomib and dexamethasone alone.
Benefit of using Pomalidomide EG together with dexamethasone
When Pomalidomide EG is used together with dexamethasone in patients who have received at least two prior treatments, it can prevent multiple myeloma from worsening:
- On average, Pomalidomide EG used with dexamethasone delayed the progression of multiple myeloma for up to 4 months, compared to 2 months in patients treated with dexamethasone alone.
2. What you need to know before taking Pomalidomide EG
Do not take Pomalidomide EG
- if you are allergic to pomalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, ask your doctor for advice;
- if you are pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide EG 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 there is any possibility that you may become pregnant unless you follow all necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is any possibility of becoming pregnant, at each prescription your doctor will record that the necessary precautions have been taken and will provide you with confirmation of this.
If you are not sure whether any of the above conditions apply to you, consult your doctor,
pharmacist, or nurse before taking Pomalidomide EG.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pomalidomide EG if:
- you have previously had episodes of blood clots. During treatment with Pomalidomide EG, there is an increased risk of blood clots forming in veins and arteries. Your doctor may recommend additional treatment (e.g. warfarin) or reduce your dose of Pomalidomide EG to reduce the likelihood of blood clots;
- you have previously had an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing, during treatment with related medicines called “thalidomide” or “lenalidomide”;
- you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure, or high cholesterol levels;
- you have a high tumour burden throughout the body, including in the bone marrow. This could lead to a condition in which tumours break down and cause unusual levels of chemicals in the blood, which can lead to kidney failure. An irregular heartbeat may also occur. This condition is called tumour lysis syndrome;
- you have or have previously had neuropathy (nerve damage causing tingling or pain in the hands or feet);
- you have or have previously had hepatitis B infection. Treatment with Pomalidomide EG may cause reactivation of the hepatitis B virus in patients carrying this virus, leading to recurrence of the infection. Your doctor must check whether you have ever had hepatitis B infection;
- you have or have previously had any combination of the following symptoms: facial or widespread rash, redness of the skin, high fever, flu-like symptoms, swollen lymph nodes (these are signs of a serious skin reaction called 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 is important to note that patients with multiple myeloma treated with pomalidomide may develop other
types of cancer; therefore, your doctor must carefully evaluate the benefit and risk when prescribing this
medicine.
At any time during or after treatment, inform your doctor or nurse immediately if you experience blurred
vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, changes in the way you
walk or problems with balance, persistent numbness, reduced sensation or loss of sensation, memory loss or
confusion. These may be symptoms of a serious and potentially fatal brain disease known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before starting treatment with Pomalidomide EG, inform your doctor of any changes in these symptoms.
After treatment is completed, you must return all unused capsules to the pharmacist.
Children and adolescents
Pomalidomide EG is not recommended for use in children and young people under 18 years of age.
Other medicines and Pomalidomide EG
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine. This is because Pomalidomide EG may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide EG.
In particular, tell your doctor, pharmacist, or nurse before taking Pomalidomide EG if you are taking any of the following medicines:
- certain antifungals, such as ketoconazole;
- certain antibiotics (e.g. ciprofloxacin, enoxacin);
- certain antidepressants, such as fluvoxamine.
Pregnancy, contraception and breastfeeding – information for women and men
The following instructions must be followed, as indicated in the Pomalidomide EG Pregnancy Prevention Programme. Women and men taking Pomalidomide EG must not become pregnant or father a child. This is because pomalidomide is expected to be harmful to the unborn baby. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide EG if you are pregnant, think you may be pregnant, or are planning a pregnancy.
This is because this medicine is expected to be harmful to the unborn baby. Before starting treatment, you must inform your doctor if there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant:
- you must use effective contraception for at least 4 weeks before starting treatment, throughout the duration of treatment, and for at least 4 weeks after stopping treatment. Consult your doctor about the most suitable contraceptive method for you.
- At each prescription, your doctor will ensure that you understand the necessary measures to prevent pregnancy.
- Your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after the end of treatment.
If you become pregnant despite preventive measures:
- you must stop treatment immediately and contact your doctor immediately.
Breast-feeding
It is not known whether Pomalidomide EG passes into breast milk. Inform your doctor if you are breast-feeding or intend to breast-feed. Your doctor will advise you whether to stop or continue breast-feeding.
Men
Pomalidomide EG passes into human seminal fluid.
- If your partner is pregnant or there is any possibility she may become pregnant, you must use condoms throughout the duration of treatment and for 7 days after stopping treatment.
- If your partner becomes pregnant during treatment with Pomalidomide EG, inform your doctor immediately. Your partner must also inform her doctor immediately.
You must not donate semen or sperm during treatment and for 7 days after stopping treatment.
Blood donation and blood tests
You must not donate blood during treatment and for 7 days after stopping treatment. Before and during treatment with Pomalidomide EG, you will undergo regular blood tests. This is because the medicine may cause a reduction in white blood cells (which fight infections) and platelets (which stop bleeding).
Your doctor will ask you to have blood tests:
- before treatment;
- weekly for the first 8 weeks of treatment;
- at least once a month thereafter, for the entire duration of treatment with Pomalidomide EG.
Based on the results of these tests, your doctor may adjust the dose of Pomalidomide EG or stop treatment. Your doctor may also adjust the dose or stop treatment based on your overall health status.
Driving and using machines
Some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness when taking Pomalidomide EG. If this occurs, do not drive or operate tools or machinery.
Pomalidomide EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.
Pomalidomide EG contains isomaltitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
3. How to take Pomalidomide EG
Pomalidomide EG must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.
Always take the medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor,
pharmacist, or nurse.
When to take Pomalidomide EG with other medicines
Pomalidomide EG with bortezomib and dexamethasone
- Read the package leaflets of bortezomib and dexamethasone for more information on their use and side effects.
- Pomalidomide EG, bortezomib, and dexamethasone are taken in "treatment cycles". Each cycle lasts 21 days (3 weeks).
- Refer to the table below to see which medicines to take each day during the 3-week cycle:
- Each day, check the chart and find the correct day to know which medicines to take.
- On some days you will take all three medicines, on some days only two or one medicine, and on other days no medicine at all. POM: Pomalidomide (Pomalidomide EG); BOR: Bortezomib; DEX: Dexamethasone
Cycles 1 to 8 From Cycle 9 onwards
| Name of the medicine | |||
| Day | POM | BOR | DEX |
| 1 | √ | √ | √ |
| 2 | √ | √ | |
| 3 | √ | ||
| 4 | √ | √ | √ |
| 5 | √ | √ | |
| 6 | √ | ||
| 7 | √ | ||
| 8 | √ | √ | √ |
| 9 | √ | √ | |
| 10 | √ | ||
| 11 | √ | √ | √ |
| 12 | √ | √ | |
| 13 | √ | ||
| 14 | √ | ||
| 15 | |||
| 16 | |||
| 17 | |||
| 18 | |||
| 19 | |||
| 20 | |||
| 21 | |||
| Name of the medicine | |||
| Day | POM | BOR | DEX |
| 1 | √ | √ | √ |
| 2 | √ | √ | |
| 3 | √ | ||
| 4 | √ | ||
| 5 | √ | ||
| 6 | √ | ||
| 7 | √ | ||
| 8 | √ | √ | √ |
| 9 | √ | √ | |
| 10 | √ | ||
| 11 | √ | ||
| 12 | √ | ||
| 13 | √ | ||
| 14 | √ | ||
| 15 | |||
| 16 | |||
| 17 | |||
| 18 | |||
| 19 | |||
| 20 | |||
| 21 | |||
- After completing each 3-week cycle, start a new one.
Pomalidomide EG with dexamethasone alone
- Refer to the dexamethasone package leaflet for further information on its use and effects.
- Pomalidomide EG and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
- Consult the following table to know which medicines to take each day of the 4-week cycle:
- Each day, check the chart and find the correct day to know which medicines to take.
- On some days you will take both medicines, on some days only one medicine, and on other days no medicine.
POM: Pomalidomide (Pomalidomide EG); DEX: Dexamethasone
| Medicinal Product 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 | √ | |
| 23 | ||
| 24 | ||
| 25 | ||
| 26 | ||
| 27 | ||
| 28 | ||
- After completing each 4-week cycle, start a new one.
Dose of Pomalidomide EG to be taken with other medicines
Pomalidomide EG with bortezomib and dexamethasone
- The recommended starting dose of Pomalidomide EG is 4 mg once daily.
- The recommended starting dose of bortezomib will be determined by your doctor based on your height and weight (1.3 mg/m² body surface area).
- The recommended starting dose of dexamethasone is 20 mg once daily. However, if you are over 75 years of age, the recommended starting dose is 10 mg once daily.
Pomalidomide EG with dexamethasone alone
- The recommended starting dose of Pomalidomide EG is 4 mg once daily.
- The recommended starting dose of dexamethasone is 40 mg once daily. However, if you are over 75 years of age, the recommended starting dose is 20 mg once daily.
Your doctor may need to reduce the dose of Pomalidomide EG, bortezomib, or dexamethasone, or discontinue one or more of these medicines based on your blood test results, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin, and fluvoxamine), and if you develop side effects (particularly rash or swelling) due to treatment.
If you have liver or kidney problems, your doctor will monitor your condition very closely during treatment with this medicine.
How to take Pomalidomide EG
- Do not split, open, or chew the capsules. If the powder from a broken Pomalidomide EG capsule comes into contact with your skin, wash the skin immediately and thoroughly with soap and water.
- Healthcare providers, 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 bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women (confirmed or suspected) must not handle the blister pack or capsule.
- Swallow the capsules whole, preferably with water.
- The capsules may be taken with or without food.
- Take Pomalidomide EG at approximately the same time each day.
To remove the capsule from the blister pack, press on one side of the capsule only, pushing it through the aluminium foil. Do not press on the center of the capsule, as this may break it.
Your doctor will inform you how and when to take Pomalidomide EG if you have kidney problems and are on dialysis.
Duration of treatment with Pomalidomide EG
You must continue the treatment cycles until your doctor tells you to stop.
If you take more Pomalidomide EG than you should
If you take more Pomalidomide EG than you should, consult your doctor or go to hospital immediately.
Take the medicine pack with you.
If you forget to take Pomalidomide EG
If you forget to take Pomalidomide EG on the prescribed day, take the next capsule as usual the following day. Do not increase the number of capsules you take to make up for the missed dose of Pomalidomide EG the previous day.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Stop taking Pomalidomide EG and contact your doctor immediately if you experience any of the
following side effects – urgent medical treatment may be needed:
- Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a lower number of white blood cells, which fight infections).
- Bleeding or bruising without cause, including nosebleeds and bleeding from the intestine or stomach (due to effects on blood cells called "platelets").
- Rapid breathing, fast pulse, fever and chills, little or no urination, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
- Severe, persistent, or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
- Chest pain or pain and swelling in the legs, especially in the lower leg or calf (caused by blood clots).
- Shortness of breath (due to severe chest infection, lung inflammation, heart failure, or blood clot).
- Swelling of the face, lips, tongue, and throat, which may cause difficulty breathing (due to severe allergic reactions called 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 skin growths. If you notice any skin changes during treatment with Pomalidomide EG, inform your doctor as soon as possible.
- Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, abdominal pain on the right side, fever, nausea, or vomiting. Inform your doctor immediately if you notice any of these symptoms.
- Widespread rash, high body temperature, 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). Stop taking pomalidomide if you experience these symptoms and contact your doctor or seek immediate medical help. See also section 2.
Stop taking Pomalidomide EG and contact your doctor immediately if any of the serious side effects listed above occur: urgent medical treatment may be required.
Other side 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).
- Low number of red blood cells, which may cause anaemia leading to tiredness 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.
- Feeling unwell (vomiting).
- Abdominal pain.
- Lack of energy.
- Difficulty falling asleep or staying asleep.
- Dizziness, tremor.
- Muscle spasms, muscle weakness.
- Bone pain, back pain.
- Numbness, tingling, or burning sensation on the skin, pain in hands or feet (peripheral sensory neuropathy).
- Swelling of the body, including arms and legs.
- Skin rashes.
- Urinary tract infection, possibly causing a burning sensation when urinating or a need to urinate more frequently.
Common (may affect up to 1 in 10 people):
- Falls.
- Bleeding within the skull.
- Reduced ability to move or feel sensations in the hands, arms, feet, and legs due to nerve damage (peripheral sensory-motor neuropathy).
- Numbness, itching, and prickling or pins-and-needles sensations on the skin (paraesthesia).
- Dizziness, difficulty standing up or moving normally.
- Swelling due to fluid retention.
- Hives (urticaria).
- Itching of the skin.
- Herpes zoster (shingles).
- Heart attack (chest pain spreading to arms, neck, jaw, sweating, shortness of breath, nausea or vomiting).
- Chest pain, chest infection.
- Increased blood pressure.
- Simultaneous reduction in red blood cells, white blood cells, and platelets (pancytopenia), increasing the risk of bleeding and bruising. You may feel tired, weak, and breathless and may be more likely to develop infections.
- Reduced 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 tiredness, generalised weakness, muscle cramps, irritability, and may lead to low calcium levels (hypocalcaemia), possibly causing numbness and/or tingling in hands, feet, or lips, muscle cramps, muscle weakness, dizziness, 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, which may cause an abnormal heart rhythm.
- Low levels of sodium in the blood, which may cause tiredness and confusion, muscle spasms, seizures, or coma.
- High levels of uric acid in the blood, which may cause a form of arthritis called gout.
- Low blood pressure, which may cause dizziness or fainting.
- Painful or dry mouth.
- Altered sense of taste.
- Bloating of the abdomen.
- Feeling confused.
- Feeling low in mood (depressed mood).
- Loss of consciousness, fainting.
- Blurred vision (cataract).
- Kidney damage.
- Inability to urinate.
- Abnormal liver function tests.
- Pelvic pain.
- Weight loss.
Uncommon (may affect up to 1 in 100 people):
- Stroke.
- Inflammation of the liver (hepatitis), which may cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
- Breakdown of tumour cells, causing the release of toxic substances into the bloodstream (tumour lysis syndrome). This may cause kidney problems.
- Underactive thyroid gland, which may cause symptoms such as tiredness, lethargy, muscle weakness, slow heartbeat, and weight gain.
Not known (frequency cannot be estimated from the available data):
- Rejection of solid organ transplant (such as heart or liver).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.
5. How to store Pomalidomide EG
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "Exp". The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Pomalidomide EG if you notice any damage or signs of tampering with the medicine packaging.
Do not dispose of any medicine via wastewater or household waste. Unused medicine must be returned to the pharmacist at the end of treatment. This will help protect the environment.
6. Package contents and other information
What Pomalidomide EG contains
- The active substance is pomalidomide.
- The other components are isomaltitol 801, isomaltitol 721, pregelatinized maize starch and sodium stearyl fumarate.
Pomalidomide EG 1 mg hard capsules
- Each hard capsule contains 1 mg of pomalidomide.
- The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172) and black ink.
Pomalidomide EG 2 mg hard capsules
- 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 ink.
Pomalidomide EG 3 mg hard capsules
- Each hard capsule contains 3 mg of pomalidomide.
- The capsule shell contains: gelatin, titanium dioxide (E171), brilliant blue FCF (E133) and black ink.
Pomalidomide EG 4 mg hard capsules
- Each hard capsule contains 4 mg of pomalidomide.
- The capsule shell contains: gelatin, brilliant blue FCF (E133), titanium dioxide (E171), erythrosine (E127) and black ink.
The printing ink contains shellac (E904), strong ammonia solution, potassium hydroxide and
black iron oxide (E172).
Description of the appearance of Pomalidomide EG and package contents
Pomalidomide EG 1 mg Hard Capsules: Opaque yellow cap and opaque yellow body, capsule size no. 4 (approximately 14 mm x 5 mm), with "LP" printed in black ink on the cap and "664" on the body, containing yellow granular powder.
Pomalidomide EG 2 mg Hard Capsules: Opaque orange cap and opaque orange body, capsule size no. 3 (approximately 16 mm x 6 mm), with "LP" printed in black ink on the cap and "665" on the body, containing yellow granular powder.
Pomalidomide EG 3 mg Hard Capsules: Opaque powder blue cap and opaque powder blue body, capsule size no. 2 (approximately 18 mm x 6 mm), with "LP" printed in black ink on the cap and "690" on the body, containing yellow granular powder.
Pomalidomide EG 4 mg Hard Capsules: Opaque blue cap and opaque blue body, capsule size no. 2 (approximately 18 mm x 6 mm), with "LP" printed in black ink on the cap and "667" on the body, containing yellow granular powder.
Pack sizes:
PVC/PCTFE (Aclar) – Aluminium and OPA/Al/PVC – Aluminium blisters:
14 hard capsules (blister)
14 x 1 hard capsules (unit dose divisible blisters)
21 hard capsules (blister)
21 x 1 hard capsules (unit dose divisible blisters)
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A.
Via Pavia 6
20136 Milan
Italy
Manufacturers
Qualimetrix S.A., Mesogeion Avenue 579 Agia Paraskevi 153 43 Athens – Greece
Adalvo Limited, Malta Life Sciences Park Building 1 Level 4 SGN 3000 San Gwann – Malta
Pharmadox Healthcare Limited, KW20A Kordin Industrial Park PLA 3000 Paola – Malta
STADA Arzneimittel AG, Stadastrasse 2-18 Bad Vilbel 61118 – Germany
STADA Arzneimittel GmbH, Muthgasse 36/2 1190 Vienna – Austria
Clonmel Healthcare Limited, Waterford Road Clonmel, Co. Tipperary E91 D768 - Ireland
This medicinal product is authorized in the European Economic Area Member States under the following names:
AT Pomalidomid STADA 1 mg/2 mg/3 mg/4 mg Hartkapseln
BE Pomalidomide EG 1 mg/2 mg/3 mg/4 mg harde capsules
CY Pomalidomide Stada
DE Pomalidomid AL 1 mg/2 mg/3 mg/4 mg Hartkapseln
DK Pomalidomide STADA
EE Pomalidomide STADA
EL Pomalidomide/Stada
ES Pomalidomida STADA 1 mg/2 mg/3 mg/4 mg cápsulas duras EFG
FI Pomalidomide STADA 1 mg/2 mg/3 mg/4 mg kapselit, kovat
FR POMALIDOMIDE EG 1 mg/2 mg/3 mg/4 mg, gélule
HU Pomalidomide Stada 1 mg/2 mg/3 mg/4 mg kemény kapszula
IE Pomalidomide Clonmel 1 mg/2 mg/3 mg/4 mg hard capsules
IS Pomalidomide STADA 1 mg/2 mg/3 mg/4 mg hörð hylki
IT Pomalidomide EG
LT Pomalidomide STADA 1 mg/2 mg/3 mg/4 mg kietosios kapsulės
LU Pomalidomide EG 1 mg/2 mg/3 mg/4 mg gélules
LV Pomalidomide STADA 1 mg/2 mg/3 mg/4 mg cietās kapsulas
NL Pomalidomide CF 1 mg/2 mg/3 mg/4 mg, harde capsules
MT Pomalidomide Clonmel 1 mg/2 mg/3 mg/4 mg hard capsules
NO Pomalidomide STADA
PL Pomalidomide Stada
PT Pomalidomida Stada
RO Pomalidomidă Stada 1 mg/2 mg/3 mg/4 mg capsule
SE Pomalidomide STADA 1 mg/2 mg/3 mg/4 mg hårda kapslar
SI Pomalidomid STADA 1 mg/2 mg/3 mg/4 mg trde kapsule
SK Pomalidomid STADA 1/2/3/4 mg tvrdé kapsuly