Pomalidomide Sandoz
Italy
Table of Contents
- Package leaflet: Information for the patient
- Pomalidomide Sandoz 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
- 1. What Pomalidomide Sandoz is and what it is used for
- 2. What you need to know before taking Pomalidomide Sandoz
- 3. How to take Pomalidomide Sandoz
- 4. Possible side effects
- 5. How to store Pomalidomide Sandoz
- 6. Package contents and other information
Package leaflet: Information for the patient
Pomalidomide Sandoz 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
Generic medicine
Pomalidomide Sandoz is expected to cause severe 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.
Please read all of this leaflet carefully before you start taking this medicine, because 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 their symptoms are the same as yours, as it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Pomalidomide Sandoz is and what it is used for
- What you need to know before taking Pomalidomide Sandoz
- How to take Pomalidomide Sandoz
- Possible side effects
- How to store Pomalidomide Sandoz
- Contents of the pack and other information
1. What Pomalidomide Sandoz is and what it is used for
What is Pomalidomide Sandoz
Pomalidomide Sandoz 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
defences).
What Pomalidomide Sandoz is used for
Pomalidomide Sandoz is used in the treatment of adults with a type of cancer called
"multiple myeloma".
Pomalidomide Sandoz 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 prior therapy including lenalidomide.
Or
- one other medicine, called "dexamethasone", in patients whose myeloma has worsened despite at least two prior therapies 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 leads to damage to the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce or eliminate signs and symptoms of the disease for a certain period of time. When this occurs, it is referred to as a "response".
How Pomalidomide Sandoz works
Pomalidomide Sandoz 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
The benefit of using Pomalidomide Sandoz in combination with bortezomib and dexamethasone
When Pomalidomide Sandoz is used together with bortezomib and dexamethasone in patients who have received at least one prior therapy, it can prevent multiple myeloma from worsening:
- On average, Pomalidomide Sandoz used with bortezomib and dexamethasone prevented the recurrence of multiple myeloma for up to 11 months, compared to 7 months in patients treated with bortezomib and dexamethasone alone.
The benefit of using Pomalidomide Sandoz in combination with dexamethasone
When Pomalidomide Sandoz is used together with dexamethasone in patients who have received at least two prior therapies, it can prevent multiple myeloma from worsening:
- On average, Pomalidomide Sandoz used with dexamethasone prevented the recurrence 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 Sandoz
Do not take Pomalidomide Sandoz:
- if you are pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Sandoz is expected to be harmful to the unborn baby. (Men and women taking this medicine should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below.)
- if there is any chance you could 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 chance you could become pregnant, your doctor will record at each prescription that the necessary precautions have been taken and will provide you with confirmation.
- if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, please consult your doctor.
If you are unsure whether any of the above conditions apply to you, consult your doctor,
pharmacist or nurse before taking Pomalidomide Sandoz.
Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Pomalidomide Sandoz if:
- you have previously experienced blood clots. During treatment with Pomalidomide Sandoz, there is an increased risk of blood clots forming in the veins and arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Sandoz to lower the risk 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 breathing difficulties, 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 abnormal levels of chemicals in the blood, potentially leading to kidney failure. You may also experience an irregular heartbeat. 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 Sandoz may cause reactivation of the hepatitis B virus in patients carrying the 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, skin redness, 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 to you.
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 balance problems, persistent numbness, reduced sensation or loss of
sensation, memory loss or confusion. These may be symptoms of a serious brain disease that can be
fatal, known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms
before starting treatment with Pomalidomide Sandoz, inform your doctor of any changes in these
symptoms.
At the end of treatment, return all unused capsules to the pharmacist.
Pregnancy, contraception and breastfeeding – information for women and men
The following instructions must be followed as indicated in the Pomalidomide Sandoz Pregnancy Prevention Programme. Women and men taking Pomalidomide Sandoz must not start a pregnancy or father a child, 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 Sandoz if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy, because this medicine is expected to be harmful to the unborn baby. Before starting
treatment, you must inform your doctor if there is any chance you could become pregnant, even if you
think it is unlikely.
If there is any chance you could become 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 confirm 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 treatment ends.
If you become pregnant despite preventive measures:
- you must stop treatment immediately and contact your doctor right away.
Breastfeeding
It is not known whether Pomalidomide Sandoz passes into breast milk. Inform your doctor if you are
breastfeeding or intend to breastfeed. Your doctor will advise you whether to stop or continue
breastfeeding.
Men
Pomalidomide Sandoz passes into human seminal fluid.
- If your partner is pregnant or there is a chance she could become pregnant, you must use condoms throughout the treatment period and for 7 days after stopping treatment.
- If your partner becomes pregnant during treatment with Pomalidomide Sandoz, 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 Sandoz, you will have regular blood tests because this
medicine may cause a reduction in blood cells that fight infections (white blood cells) and cells that
stop bleeding (platelets).
Your doctor will ask you to have blood tests:
- before starting treatment
- weekly for the first 8 weeks of treatment
- at least once a month thereafter, for the entire duration of treatment with Pomalidomide Sandoz.
Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Sandoz or
discontinue treatment. Your doctor may also adjust the dose or stop treatment based on your overall
health status.
Children and adolescents
The use of Pomalidomide Sandoz is not recommended in children and adolescents under 18 years of
age.
Other medicines and Pomalidomide Sandoz
Inform your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other
medicines. This is because Pomalidomide Sandoz may affect the action of other medicines and other
medicines may affect the action of Pomalidomide Sandoz.
In particular, inform your doctor, pharmacist or nurse before taking Pomalidomide Sandoz 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.
Driving and using machines
Some people may experience tiredness, dizziness, fainting, confusion or reduced alertness when taking
Pomalidomide Sandoz. If this occurs, do not drive or operate tools or machinery.
Pomalidomide Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.
3. How to take Pomalidomide Sandoz
Pomalidomide Sandoz must be administered by a physician experienced in the treatment of multiple
myeloma.
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor, pharmacist, or nurse.
When to take Pomalidomide Sandoz with other medicines
Pomalidomide Sandoz with bortezomib and dexamethasone
- Read the package leaflet for bortezomib and dexamethasone for further information on their use and effects.
- Pomalidomide Sandoz, 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 of the 3-week cycle.
- Each day, check the table to find the correct day and determine 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.
POM: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone
Cycles 1 to 8
| Medicine Name | |||
| 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 | |||
From Cycle 9 onwards
| Name of 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 Sandoz with dexamethasone alone
- Refer to the dexamethasone package leaflet for further information on its use and effects.
- Pomalidomide Sandoz and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
- Refer to the table below to see which medicines to take each day of the 4-week cycle.
- Each day, check the chart and find the correct day to determine 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; DEX: Dexamethasone
| Medicine Name | ||
| Day | POM | DEX |
| 1 | ||
| 2 | ||
| 3 | ||
| 4 | ||
| 5 | ||
| 6 | ||
| 7 | ||
| 8 | ||
| 9 | ||
| 10 | ||
| 11 | ||
| 12 | ||
| 13 | ||
| 14 | ||
| 15 | ||
| 16 | ||
| 17 | ||
| 18 | ||
| 19 | ||
| 20 | ||
| 21 | ||
| 22 | ||
| 23 | ||
| 24 | ||
| 25 | ||
| 26 | ||
| 27 | ||
| 28 | ||
- After completing each 4-week cycle, start a new one.
Dose of Pomalidomide Sandoz to be taken with other medicines
Pomalidomide Sandoz with bortezomib and dexamethasone
- The recommended starting dose of Pomalidomide Sandoz 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 of body surface area).
- The recommended starting dose of dexamethasone is 20 mg daily. However, if you are over 75 years of age, the recommended starting dose is 10 mg daily.
Pomalidomide Sandoz with dexamethasone alone
- The recommended starting dose of Pomalidomide Sandoz is 4 mg once daily.
- The recommended starting dose of dexamethasone is 40 mg daily. However, if you are over 75 years of age, the recommended starting dose is 20 mg daily.
Your doctor may need to reduce the dose of Pomalidomide Sandoz, bortezomib, or dexamethasone, or
discontinue one or more of these medicines based on the results of blood tests, 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 Sandoz
- Do not break, open, or chew the capsules. If the powder from a broken capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
- Healthcare providers, caregivers, and family members must 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 thoroughly washed with soap and water. Pregnant women (confirmed or suspected) must not handle the blister pack or capsule.
- Swallow the capsules whole, preferably with water.
- Capsules may be taken with or without food.
- Take the capsules at approximately the same time each day.
To remove the capsule from the blister, press on one side of the capsule, pushing it through the aluminum foil. Do not press on the center of the capsule, as this may cause it to break.
Your doctor will inform you how and when to take Pomalidomide Sandoz if you have kidney problems and
are undergoing dialysis.
Duration of treatment with Pomalidomide Sandoz
You must continue the treatment cycles until your doctor tells you to stop.
If you take more Pomalidomide Sandoz than you should
If you take more Pomalidomide Sandoz than you should, consult your doctor or go to hospital
immediately. Take the medicine package with you.
If you forget to take Pomalidomide Sandoz
If you forget to take Pomalidomide Sandoz on the prescribed day, take the next capsule as usual the
following day. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult 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 Sandoz and contact your doctor immediately if you experience any of the following serious side effects – urgent medical treatment may be required:
- 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 intestinal or stomach bleeding (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 types of 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 Sandoz, 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 these symptoms occur and contact your doctor or seek immediate medical help. See also section 2.
Stop taking Pomalidomide Sandoz 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 red blood cell count, 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 levels of sugar in the blood
- Rapid and irregular heartbeat (atrial fibrillation)
- Decreased appetite
- Constipation, diarrhoea or nausea
- Vomiting
- Abdominal pain
- Lack of energy
- Difficulty falling asleep or staying asleep
- Dizziness, tremor
- Muscle spasm, 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, which may cause a burning sensation when urinating or the 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 pins-and-needles sensation on the skin (paraesthesia)
- Sensation of dizziness, with difficulty standing up and moving normally
- Swelling caused by fluid retention
- Hives (urticaria)
- Itching
- Herpes zoster (shingles)
- Heart attack (chest pain spreading to the 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 in the blood (hypocalcaemia), which may cause 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
- 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 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, talk to 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Pomalidomide Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any damage or signs of tampering on the package.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Pomalidomide Sandoz contains
The active substance is pomalidomide.
The other components are microcrystalline cellulose (E460), maltodextrin and sodium stearyl fumarate.
Pomalidomide Sandoz 1 mg hard capsule:
- Each capsule contains 1 mg of pomalidomide.
- The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and white ink.
- The printing ink contains: shellac, titanium dioxide (E171), propylene glycol.
Pomalidomide Sandoz 2 mg hard capsule:
- Each capsule contains 2 mg of pomalidomide.
- The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and white ink.
- The printing ink contains: shellac, titanium dioxide (E171), propylene glycol.
Pomalidomide Sandoz 3 mg hard capsule:
- Each capsule contains 3 mg of pomalidomide.
- The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), aluminium indigo carmine lake and white ink.
- The printing ink contains: shellac, titanium dioxide (E171), propylene glycol.
Pomalidomide Sandoz 4 mg hard capsule:
- Each capsule contains 4 mg of pomalidomide.
- The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), aluminium indigo carmine lake (E132), erythrosine (E171) and white ink.
- The printing ink contains: shellac, titanium dioxide (E171), propylene glycol.
Description of the appearance of Pomalidomide Sandoz and contents of the pack
Pomalidomide Sandoz 1 mg hard capsules: hard gelatin capsules with a red cap and a yellow body, printed with "PLM 1" in white axial print on the body.
Pomalidomide Sandoz 2 mg hard capsules: hard gelatin capsules with a red cap and an orange body, printed with "PLM 2" in white axial print on the body.
Pomalidomide Sandoz 3 mg hard capsules: hard gelatin capsules with a red cap and a turquoise body, printed with "PLM 3" in white axial print on the body.
Pomalidomide Sandoz 4 mg hard capsules: hard gelatin capsules with a red cap and a dark blue body, printed with "PLM 4" in white axial print on the body.
Pomalidomide Sandoz 1 mg hard capsules are available in blisters or unit-dose divisible blisters. Each pack contains 14, 21, 14x1 or 21x1 capsules.
Pomalidomide Sandoz 2 mg hard capsules are available in blisters or unit-dose divisible blisters. Each pack contains 14, 21, 14x1 or 21x1 capsules.
Pomalidomide Sandoz 3 mg hard capsules are available in blisters or unit-dose divisible blisters. Each pack contains 14, 21, 14x1 or 21x1 capsules.
Pomalidomide Sandoz 4 mg hard capsules are available in blisters or unit-dose divisible blisters. Each pack contains 14, 21, 14x1 or 21x1 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A.,
Largo U. Boccioni 1
20027 Origgio (VA)
Italy
Manufacturers
Synthon Hispania S.L.
C/Castellò, 1 Poligono Las Salinas
08830 Sant Boi de Llobregat, Barcelona
Spain
Synthon BV
Microweg 22, 6545 CM Nijmegen,
The Netherlands
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben,
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Pomalidomid 1 mg Hard Capsules
Pomalidomid 2 mg Hard Capsules
Pomalidomid 3 mg Hard Capsules
Pomalidomid 4 mg Hard Capsules
Cyprus Pomalidomide/Sandoz
Denmark Pomalidomide Sandoz
Estonia Pomalidomide Sandoz
Finland Pomalidomide Sandoz 1 mg capsules, hard
Pomalidomide Sandoz 2 mg capsules, hard
Pomalidomide Sandoz 3 mg capsules, hard
Pomalidomide Sandoz 4 mg capsules, hard
France POMALIDOMIDE SANDOZ 1 mg, capsule
POMALIDOMIDE SANDOZ 2 mg, capsule
POMALIDOMIDE SANDOZ 3 mg, capsule
POMALIDOMIDE SANDOZ 4 mg, capsule
Germany Pomalidomid Hexal 1 mg Hard Capsules
Pomalidomid Hexal 2 mg Hard Capsules
Pomalidomid Hexal 3 mg Hard Capsules
Pomalidomid Hexal 4 mg Hard Capsules
Greece Pomalidomide/Sandoz
Iceland Pomalidomide Sandoz
Italy Pomalidomide Sandoz
Latvia Pomalidomide Sandoz 1 mg hard capsules
Pomalidomide Sandoz 2 mg hard capsules
Pomalidomide Sandoz 3 mg hard capsules
Pomalidomide Sandoz 4 mg hard capsules
Lithuania Pomalidomide Sandoz 1 mg hard caps
Pomalidomide Sandoz 2 mg hard caps
Pomalidomide Sandoz 3 mg hard caps
Pomalidomide Sandoz 4 mg hard caps
Malta Pomalidomide Sandoz 1 mg capsules, hard
Pomalidomide Sandoz 2 mg capsules, hard
Pomalidomide Sandoz 3 mg capsules, hard
Pomalidomide Sandoz 4 mg capsules, hard
Norway Pomalidomide Sandoz
The Netherlands Pomalidomide Sandoz 1 mg, hard capsules
Pomalidomide Sandoz 2 mg, hard capsules
Pomalidomide Sandoz 3 mg, hard capsules
Pomalidomide Sandoz 4 mg, hard capsules
Poland Pomalidomide Sandoz
Czech Republic Pomalidomide Sandoz
Slovak Republic Pomalidomide Sandoz 1 mg
Pomalidomide Sandoz 2 mg
Pomalidomide Sandoz 3 mg
Pomalidomide Sandoz 4 mg
Romania Pomalidomidă Sandoz 1 mg capsules
Pomalidomidă Sandoz 2 mg capsules
Pomalidomidă Sandoz 3 mg capsules
Pomalidomidă Sandoz 4 mg capsules
Slovenia Pomalidomid Sandoz 1 mg hard capsules
Pomalidomid Sandoz 2 mg hard capsules
Pomalidomid Sandoz 3 mg hard capsules
Pomalidomid Sandoz 4 mg hard capsules
Spain Pomalidomida Sandoz 1 mg hard capsules EFG
Pomalidomida Sandoz 2 mg hard capsules EFG
Pomalidomida Sandoz 3 mg hard capsules EFG
Pomalidomida Sandoz 4 mg hard capsules EFG
Sweden Pomalidomide Sandoz
Hungary Pomalidomide Sandoz 1 mg hard caps
Pomalidomide Sandoz 2 mg hard caps
Pomalidomide Sandoz 3 mg hard caps
Pomalidomide Sandoz 4 mg hard caps