Pomalidomide sandoz

Poland
Brand name Pomalidomide sandoz
Form capsules, hard
Active substance / Dosage
Prescription type Prescription only – restricted use
ATC code
Registration number 100486650
Pomalidomide sandoz capsules, hard

Patient Information Leaflet

Pomalidomide Sandoz, 1 mg, hard capsules
Pomalidomide Sandoz, 2 mg, hard capsules
Pomalidomide Sandoz, 3 mg, hard capsules
Pomalidomide Sandoz, 4 mg, hard capsules
Pomalidomide
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 able to 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 you personally. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
  • If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

What Pomalidomide Sandoz is
Pomalidomide Sandoz 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 Sandoz is used for
Pomalidomide Sandoz is used to treat adults with a type of cancer called multiple myeloma.
Pomalidomide Sandoz 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 therapy containing lenalidomide

or

  • one other medicine, dexamethasone, in patients with multiple myeloma whose disease has worsened despite having previously received at least two prior therapies containing lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a cancer that affects a certain type of white blood cells (called plasma cells). These cells grow uncontrollably and accumulate in the bone marrow, leading to bone and kidney damage.
Multiple myeloma cannot usually be cured. However, treatment may relieve symptoms or cause the disease to go into remission for a period of time—this is known as a "response" to treatment.

How Pomalidomide Sandoz works
Pomalidomide Sandoz 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.

Benefits of using Pomalidomide Sandoz with bortezomib and dexamethasone
Pomalidomide Sandoz used together with bortezomib and dexamethasone in patients who have already received at least one prior therapy may slow the progression of multiple myeloma.

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

Benefits of using Pomalidomide Sandoz with dexamethasone
Pomalidomide Sandoz used together with dexamethasone in patients who have already received at least two prior therapies may slow the progression of multiple myeloma.

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

2. Important information before taking Pomalidomide Sandoz

When not to take Pomalidomide Sandoz:

  • if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant – because Pomalidomide Sandoz 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 the patient could become pregnant, unless she uses all necessary measures to prevent pregnancy (see section "Pregnancy, contraception and breastfeeding – information for women and men"). If the patient could become pregnant, the doctor will document that the necessary precautions have been taken and provide the patient with written confirmation.
  • if the patient is allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If an allergic reaction to the medicine is suspected, the patient should consult a doctor for advice.

If the patient is unsure whether any of the above situations apply, they should consult their
doctor, pharmacist, or nurse before starting treatment with Pomalidomide Sandoz.
Warnings and precautions
Before starting treatment with Pomalidomide Sandoz, discuss with the doctor,
pharmacist, or nurse if:

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

  • the patient has ever experienced an allergic reaction such as rash, itching, swelling, dizziness, or breathing difficulties while taking similar medicines called "thalidomide" or "lenalidomide".

  • the patient has had a heart attack, has heart failure, experiences breathing difficulties, or if they smoke, have 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 a condition in which tumours break down rapidly, causing abnormal levels of chemical substances in the blood, potentially leading to kidney failure. The patient may also experience irregular heartbeat. 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 Sandoz may reactivate the virus in previously infected patients, leading to a recurrence of infection. The doctor should check whether the patient has been previously infected with hepatitis B virus.

  • the patient has or has had any combination of the following symptoms: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, swollen lymph nodes (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 in patients with multiple myeloma treated with pomalidomide, there may be an increased risk of developing other types of cancer. Therefore, the treating doctor should carefully evaluate the benefits and risks associated with prescribing this medicine.
At any time during or after completion of treatment, the patient should immediately inform the
doctor or nurse if they experience: blurred vision, loss of vision or double vision,
difficulty speaking, weakness in arms or legs, change in walking or balance problems,
persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation.
All of these symptoms may indicate a serious and potentially life-threatening brain disorder
called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before
treatment with Pomalidomide Sandoz, the patient should inform the doctor of any changes in these
symptoms.
After treatment ends, any unused capsules should be returned to the pharmacist.
Pregnancy, contraception and breastfeeding – information for women and men
While taking Pomalidomide Sandoz, patients must follow the pregnancy prevention requirements outlined in the pregnancy prevention programme. Women taking Pomalidomide Sandoz must not become pregnant, and men taking Pomalidomide Sandoz must not father a child, because this medicine is expected to harm the unborn child. Both the patient and their partner must use effective methods of contraception during treatment with this medicine.
Women
Do not take Pomalidomide Sandoz if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because this medicine is expected to harm the unborn child. Before starting treatment, the patient should inform the treating doctor whether she could become pregnant, even if she considers it unlikely.
If the patient could become pregnant:

  • she 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. The patient should discuss with her treating doctor which method of contraception is best suited for her.
  • at each prescription renewal, the treating doctor will confirm that the patient understands the necessary measures to prevent pregnancy.
  • the treating doctor will order pregnancy tests before treatment, at least every 4 weeks during treatment, and for at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive measures:

  • she must immediately stop treatment and immediately inform her treating doctor.

Breastfeeding
It is not known whether Pomalidomide Sandoz passes into human breast milk. If the patient is breastfeeding or intends to breastfeed, she must inform her treating doctor. The treating doctor will advise the patient whether she should stop or continue breastfeeding.
Men
Pomalidomide Sandoz passes into human semen.

  • if the partner is pregnant or could become pregnant, the man must use condoms throughout the entire treatment period and for 7 days after stopping treatment.
  • if the partner of a man undergoing treatment with Pomalidomide Sandoz becomes pregnant, the doctor must be informed immediately. The partner should also seek immediate medical advice.

The patient must not donate sperm 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 Sandoz, the patient will undergo regular blood tests. This is because this medicine may reduce the number of blood cells that help fight infections (white blood cells) and the number of cells that help stop bleeding (platelets).
The treating doctor should order blood tests:

  • before treatment begins,
  • weekly during the first 8 weeks of treatment,
  • thereafter at least once a month for as long as the patient is taking Pomalidomide Sandoz.

The treating doctor may adjust the dose of Pomalidomide Sandoz or discontinue treatment based on the patient's blood test results. The treating doctor may also change the dose or stop treatment due to the patient's overall health condition.
Children and adolescents
Pomalidomide Sandoz is not recommended for use in children and adolescents under 18 years of age.
Pomalidomide Sandoz and other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken, because Pomalidomide Sandoz may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Sandoz.
Before taking Pomalidomide Sandoz, 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 Sandoz, some patients may experience fatigue, dizziness, fainting, disorientation, or reduced alertness. If such symptoms occur, the patient should not drive, operate tools, or use machinery.
Pomalidomide Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "sodium-free".

3. How to take Pomalidomide Sandoz

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

  • Read the package leaflets provided with bortezomib and dexamethasone for further information about their use and effects.
  • Pomalidomide Sandoz, 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: o for each day, locate the corresponding day in the table and check which medicines need to be taken. o on some days all three medicines are taken, on some days only two or one medicine, and on some days no medicine is taken.

POM: Pomalidomide; BOR: bortezomib; DEX: dexamethasone

Two tables with a treatment schedule divided into cycles 1 to 8 and cycle 9 and beyond, with columns labeled Day, POM, BOR, and DEX, and marked fields
  • After completing each 3-week cycle, start a new cycle.

Pomalidomide Sandoz with dexamethasone only

  • Read the package leaflet provided with dexamethasone for further information about its use and effects.
  • Pomalidomide Sandoz and dexamethasone are administered in treatment cycles. Each cycle lasts 28 days (4 weeks).
  • The table below helps to determine which medicines should be taken on each day of the 4-week cycle: o for each day, locate the corresponding day in the table and check which medicines need to be taken. o on some days both medicines are taken, on some days only one medicine, and on some days no medicine is taken.

POM: Pomalidomide; DEX: dexamethasone

A 28-day table with two medication columns, POM and DEX, where POM is marked for days 1 to 21 and DEX for days 1, 8, 15, and 22
  • After completing each 4-week cycle, start a new cycle.

What dose of Pomalidomide Sandoz should 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 the physician 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, for patients over 75 years of age, the recommended starting dose is 10 mg once daily.

Pomalidomide Sandoz with dexamethasone only

  • The recommended dose of Pomalidomide Sandoz is 4 mg once daily.
  • The recommended starting dose of dexamethasone is 40 mg once daily. However, for patients over 75 years of age, the recommended starting dose is 20 mg once daily.

The physician may reduce the dose of Pomalidomide Sandoz, bortezomib, or dexamethasone, or
may recommend interrupting the use of one or more of these medicines, depending on the patient's
blood test results, general health condition, concomitant 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 treating physician will closely monitor the patient's
health during treatment with this medicine.
How to take Pomalidomide Sandoz

  • Do not crush, 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 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. Capsules should be swallowed whole, preferably with water. Capsules may be taken with or without food. Pomalidomide Sandoz should be taken at approximately the same time each day.

To remove a capsule from the blister, press the blister pack only at one end of the capsule and push
the capsule through the foil. Do not press the blister in the middle of the capsule, as this may damage
the capsule.

A schematic instruction showing fingers pressing and sliding a part of a medical capsule to properly open or prepare it

If the patient has kidney disease and is on dialysis, the treating physician will advise on how and
when to take Pomalidomide Sandoz.
Duration of treatment with Pomalidomide Sandoz
Treatment cycles should be continued until the physician advises to stop treatment.
Overdose of Pomalidomide Sandoz
If a dose of Pomalidomide Sandoz higher than recommended is taken, contact the physician immediately or go to the hospital. Bring the medicine packaging with you.
Missed dose of Pomalidomide Sandoz
If the patient misses a dose of Pomalidomide Sandoz on the day it should have been taken, take the next capsule at the scheduled time the following day. Do not take a double dose to make up for the missed Pomalidomide Sandoz capsule.
If there are any further questions about the use of this medicine, consult the physician 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, discontinue taking Pomalidomide Sandoz immediately and contact a doctor without delay – immediate treatment may be required:

  • fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to reduced number of white blood cells that 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 and lower leg (due to blood clots)
  • shortness of breath (due to severe chest infections, pneumonia, heart failure or blood clots)
  • swelling of the face, lips, tongue and throat, which may cause breathing difficulties (due to severe allergic reactions known as angioedema and anaphylactic reaction)
  • certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the skin's appearance or the development of skin growths. If a patient notices any skin changes while taking Pomalidomide Sandoz, this should be reported to a 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 these symptoms occur.
  • widespread rash, high fever, swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome). If these symptoms occur, stop taking pomalidomide immediately and contact a doctor or seek urgent medical help. See also section 2.

If any of the above serious adverse reactions occur, discontinue taking Pomalidomide Sandoz immediately and contact a doctor without delay – immediate treatment may be required.
Other adverse reactions
Very common (may affect more than 1 in 10 people):

  • shortness of breath (dyspnoea)
  • lung infections (pneumonia and bronchitis)
  • infections of the nose, sinuses and throat caused by bacteria or viruses
  • influenza-like symptoms (influenza)
  • reduced number of red blood cells, which may lead to anaemia causing fatigue and weakness
  • low blood potassium levels (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) 9
  • loss of appetite
  • constipation, diarrhoea or nausea
  • vomiting
  • abdominal pain
  • lack of energy
  • difficulty falling asleep or maintaining sleep
  • dizziness, tremor
  • muscle cramps, muscle weakness
  • bone pain, back pain
  • swelling of the body, including hands and feet
  • skin 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):

  • fall
  • 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 (paraesthesia)
  • sensation of spinning in the head, making it difficult to maintain proper standing posture and normal movement
  • swelling due to fluid accumulation
  • urticaria
  • skin itching
  • shingles
  • 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 reduction 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 be more prone to infections
  • reduced number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia)
  • low blood magnesium levels (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, irritability, and may lead to low blood calcium levels (hypocalcaemia), which may cause numbness and (or) tingling of hands, feet or lips, muscle cramps, muscle weakness, dizziness, confusion
  • low blood phosphate levels (hypophosphataemia), which may cause muscle weakness, irritability or confusion
  • high blood calcium levels (hypercalcaemia), which may cause slowed reflexes and skeletal muscle weakness
  • high blood potassium levels, which may cause irregular heartbeat
  • low blood sodium levels, which may cause fatigue and confusion, muscle twitching, seizures (epileptic fits) or coma
  • high blood uric acid levels, which may lead to joint inflammation in the form of gout
  • low blood pressure, which may cause dizziness or fainting
  • pain or dryness in the mouth
  • changes in taste sensation
  • abdominal swelling 10
  • feeling of confusion
  • 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 skin itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine and abdominal pain
  • tumour lysis syndrome, which is the breakdown of tumour cells leading to the release of toxic substances into the blood. This may lead to kidney problems.
  • hypothyroidism, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heartbeat, weight gain.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
PL-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 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 pack and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Do not use this medicine if you notice any damage or signs of tampering with the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Pomalidomide Sandoz contains

  • The active substance is pomalidomide.
  • The other ingredients are: microcrystalline cellulose (E 460), 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 (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and white ink.
  • The white ink contains: shellac, titanium dioxide (E 171), and propylene glycol.

Pomalidomide Sandoz 2 mg, hard capsule.

  • Each capsule contains 2 mg of pomalidomide.
  • The capsule shell contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and white ink.
  • The white ink contains: shellac, titanium dioxide (E 171), and propylene glycol.

Pomalidomide Sandoz 3 mg, hard capsule.

  • Each capsule contains 3 mg of pomalidomide.
  • The capsule shell contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132), and white ink.
  • The white ink contains: shellac, titanium dioxide (E 171), and propylene glycol.

Pomalidomide Sandoz 4 mg, hard capsule.

  • Each capsule contains 4 mg of pomalidomide.
  • The capsule shell contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132), erythrosine, and white ink.
  • The white ink contains: shellac, titanium dioxide (E 171), and propylene glycol.

What Pomalidomide Sandoz looks like and contents of the pack
Pomalidomide Sandoz 1 mg, hard capsules
Hard gelatin capsule with a yellow body and red cap, printed with the white characters "PLM 1" along the body of the capsule.
Pomalidomide Sandoz 2 mg, hard capsules
Hard gelatin capsule with an orange body and red cap, printed with the white characters "PLM 2" along the body of the capsule.
Pomalidomide Sandoz 3 mg, hard capsules
Hard gelatin capsule with a turquoise body and red cap, printed with the white characters "PLM 3" along the body of the capsule.
Pomalidomide Sandoz 4 mg, hard capsules
Hard gelatin capsule with a dark blue body and red cap, printed with the white characters "PLM 4" along the body of the capsule.
The hard capsules are packed in blisters or unit dose blisters in a cardboard carton.
Pack sizes contain 14, 21, 56, 63, 14x1 or 21x1 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
tel. 22 209 70 00

Manufacturer
Synthon Hispania S.L.
Calle De Castello 1
08830 Sant Boi De Llobregat
Barcelona, Spain

Synthon B.V.
Microweg 22
6545 CM Nijmegen, The Netherlands
Salutas Pharma GmbH Otto-Von-Guericke-Allee 1 39179 Barleben Saxony-Anhalt, Germany

This medicinal product is authorised in the member states of the European Economic Area under the following names:
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
Austria Pomalidomid Sandoz 1 mg – Hard capsules
Pomalidomid Sandoz 2 mg – Hard capsules
Pomalidomid Sandoz 3 mg – Hard capsules
Pomalidomid Sandoz 4 mg – Hard capsules
Czech Republic Pomalidomide Sandoz
Cyprus Pomalidomide/Sandoz
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
Denmark Pomalidomide Sandoz
Estonia Pomalidomide Sandoz
Greece Pomalidomide/Sandoz
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
Finland Pomalidomide Sandoz 1 mg hard capsules
Pomalidomide Sandoz 2 mg hard capsules
Pomalidomide Sandoz 3 mg hard capsules
Pomalidomide Sandoz 4 mg hard capsules
France POMALIDOMIDE SANDOZ 1 mg, capsule
POMALIDOMIDE SANDOZ 2 mg, capsule
POMALIDOMIDE SANDOZ 3 mg, capsule
POMALIDOMIDE SANDOZ 4 mg, capsule
Hungary Pomalidomide Sandoz 1 mg hard capsule
Pomalidomide Sandoz 2 mg hard capsule
Pomalidomide Sandoz 3 mg hard capsule
Pomalidomide Sandoz 4 mg hard capsule
Iceland Pomalidomide Sandoz
Ireland Pomalidomide Rowex 1 mg hard capsules
Pomalidomide Rowex 2 mg hard capsules
Pomalidomide Rowex 3 mg hard capsules
Pomalidomide Rowex 4 mg hard capsules
Italy Pomalidomide Sandoz
Latvia Pomalidomide Sandoz 1 mg hard capsule
Pomalidomide Sandoz 2 mg hard capsule
Pomalidomide Sandoz 3 mg hard capsule
Pomalidomide Sandoz 4 mg hard capsule
Lithuania Pomalidomide Sandoz 1 mg hard capsules
Pomalidomide Sandoz 2 mg hard capsules
Pomalidomide Sandoz 3 mg hard capsules
Pomalidomide Sandoz 4 mg hard capsules
Malta Pomalidomide Sandoz 1 mg capsule, hard
Pomalidomide Sandoz 2 mg capsule, hard
Pomalidomide Sandoz 3 mg capsule, hard
Pomalidomide Sandoz 4 mg capsule, hard
Norway Pomalidomide Sandoz
Poland Pomalidomide Sandoz
Romania Pomalidomida Sandoz 1 mg, capsule
Pomalidomida Sandoz 2 mg, capsule
Pomalidomida Sandoz 3 mg, capsule
Pomalidomida Sandoz 4 mg, capsule
Slovakia Pomalidomide Sandoz 1 mg
Pomalidomide Sandoz 2 mg
Pomalidomide Sandoz 3 mg
Pomalidomide Sandoz 4 mg
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
Sweden Pomalidomide Sandoz
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