Pomalidomide G.L. Pharma

Package leaflet: Information for the patient

Pomalidomide G.L. Pharma 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide
Pomalidomide G.L. Pharma 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 leaflet carefully before 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 they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Pomalidomide G.L. Pharma is and what it is used for
2. What you need to know before taking Pomalidomide G.L. Pharma
3. How to take Pomalidomide G.L. Pharma
4. Possible side effects
5. How to store Pomalidomide G.L. Pharma
6. Contents of the pack and other information

1. What is Pomalidomide G.L. Pharma and what is it used for

What is Pomalidomide G.L. Pharma
Pomalidomide G.L. Pharma 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 G.L. Pharma is used for
Pomalidomide G.L. Pharma is used to treat adults with a type of cancer called "multiple myeloma".
Pomalidomide G.L. Pharma 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 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 G.L. Pharma works
Pomalidomide G.L. Pharma 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 G.L. Pharma in combination with bortezomib and dexamethasone
When Pomalidomide G.L. Pharma 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 G.L. Pharma used with bortezomib and dexamethasone delayed 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 G.L. Pharma in combination with dexamethasone
When Pomalidomide G.L. Pharma 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 G.L. Pharma used with dexamethasone delayed the recurrence of multiple myeloma for up to 4 months, compared to 2 months in patients treated with dexamethasone alone.

2. What you should know before taking Pomalidomide G.L. Pharma

Do not take Pomalidomide G.L. Pharma:

• If you are pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide G.L. Pharma is expected to be harmful to the fetus. (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 to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, consult your doctor for advice.

If you are unsure whether any of the above conditions apply to you, consult your doctor,
pharmacist, or nurse before taking Pomalidomide G.L. Pharma.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pomalidomide G.L. Pharma if:

• you have previously had episodes of blood clots. During treatment with Pomalidomide G.L. Pharma, there is an increased risk of blood clots forming in the veins (thrombi) and arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reduce the dose of Pomalidomide G.L. Pharma to reduce the likelihood of blood clots forming;
• 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, which may lead 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 G.L. Pharma 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 a 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.
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 G.L. Pharma,
inform your doctor of any changes in these symptoms.
After treatment, you must 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 G.L. Pharma Pregnancy Prevention Programme.
Women and men taking Pomalidomide G.L. Pharma must not become pregnant or father a child, because pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide G.L. Pharma if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, because this medicine is expected to be harmful to the fetus. Before starting treatment,
you must inform your doctor if there is any possibility you could become pregnant, even if you think it is unlikely.
If there is any chance you could become pregnant:

• you must use effective contraceptive methods 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 treatment ends.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and consult your doctor right away.

Breastfeeding
It is not known whether Pomalidomide G.L. Pharma 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 G.L. Pharma 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 duration of treatment and for 7 days after treatment ends.
• If your partner becomes pregnant during treatment with Pomalidomide G.L. Pharma, inform your doctor immediately. Your partner must also inform her doctor immediately.

You must not donate seminal fluid or sperm during treatment and for 7 days after treatment ends.
Blood donation and blood tests
You must not donate blood during treatment and for 7 days after treatment ends.
Before and during treatment with Pomalidomide G.L. Pharma, you will undergo regular blood tests,
because this medicine may cause a reduction in blood cells that fight infections
(white blood cells) and in cells that stop bleeding (platelets).
Your doctor will ask you to have blood tests:

• before treatment starts
• weekly for the first 8 weeks of treatment
• at least once a month thereafter, for the entire duration of treatment with Pomalidomide G.L. Pharma.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide G.L. Pharma or
discontinue treatment. Your doctor may also adjust the dose or discontinue treatment based on
your overall health status.
Children and adolescents
The use of Pomalidomide G.L. Pharma is not recommended in children and adolescents under 18
years of age.
Other medicines and Pomalidomide G.L. Pharma
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Pomalidomide G.L. Pharma may affect the action of other medicines and other medicines may affect the action of Pomalidomide G.L. Pharma.
In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide G.L. Pharma
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 fatigue, dizziness, fainting, confusion, or reduced alertness when taking Pomalidomide G.L. Pharma. If this occurs, do not drive or operate tools or machinery.
Pomalidomide G.L. Pharma 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 G.L. Pharma

Pomalidomide G.L. Pharma must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor, pharmacist, or nurse.

When to take Pomalidomide G.L. Pharma with other medicines

Pomalidomide G.L. Pharma with bortezomib and dexamethasone

• Read the package leaflet of bortezomib and dexamethasone for more information on their use and effects.
• Pomalidomide G.L. Pharma, 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.
• Check the schedule daily and find the correct day to 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 at all. POM: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone

Cycles 1 to 8 From Cycle 9 onwards
Medicine name Medicine name
Day POM BOR DEX Day POM BOR DEX
1 √ √ √ 1 √ √ √
2 √ √ 2 √ √
3 √ 3 √
4 √ √ √ 4 √
5 √ √ 5 √
6 √ 6 √
7 √ 7 √
8 √ √ √ 8 √ √ √
9 √ √ 9 √ √
10 √ 10 √
11 √ √ √ 11 √
12 √ √ 12 √
13 √ 13 √
14 √ 14 √
15 15
16 16
17 17
18 18
19 19
20 20
21 21

• After completing each 3-week cycle, start a new one.

Pomalidomide G.L. Pharma with dexamethasone alone

• Refer to the dexamethasone package leaflet for more information on its use and effects.

• Pomalidomide G.L. Pharma 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.

• Check the schedule daily 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 at all.

• 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 √

• After completing each 4-week cycle, start a new one.

Dosage of Pomalidomide G.L. Pharma when taken with other medicines

Pomalidomide G.L. Pharma with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide G.L. Pharma 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 per day. However, if you are over 75 years of age, the recommended starting dose is 10 mg per day.

Pomalidomide G.L. Pharma with dexamethasone alone

• The recommended starting dose of Pomalidomide G.L. Pharma is 4 mg once daily.
• The recommended starting dose of dexamethasone is 40 mg per day. However, if you are over 75 years of age, the recommended starting dose is 20 mg per day.

Your doctor may need to reduce the dose of Pomalidomide G.L. Pharma, bortezomib, or dexamethasone, or discontinue one or more of these medicines, based on blood test results, your general condition, other medicines you may be taking (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if you experience side effects (especially 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 G.L. Pharma

• 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 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 or those who suspect they may be pregnant 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 the capsules 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 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 G.L. Pharma if you have kidney problems and are undergoing dialysis.

Duration of treatment with Pomalidomide G.L. Pharma

You must continue the treatment cycles until your doctor tells you to stop.

If you take more Pomalidomide G.L. Pharma than you should

If you take more Pomalidomide G.L. Pharma than prescribed, contact your doctor or go to a hospital immediately. Take the medicine packaging with you.

If you forget to take Pomalidomide G.L. Pharma

If you forget to take Pomalidomide G.L. Pharma on the prescribed day, take the next capsule as usual the following day. Do not increase the number of capsules taken to make up for the missed dose of Pomalidomide G.L. Pharma the previous day.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
Stop taking Pomalidomide G.L. Pharma 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 reduced 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, rapid 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 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 skin growths. If you notice any skin changes during treatment with Pomalidomide G.L. Pharma, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, 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 G.L. Pharma and contact your doctor immediately
if any of the above-mentioned serious side effects 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 fatigue and weakness.
• Low levels of potassium in the blood (hypokalaemia), which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
• High blood sugar levels.
• 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 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 swelling of the arms and legs.
• Skin rashes.
• Urinary tract infection, which may cause a burning sensation during urination 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 system damage (peripheral sensory-motor neuropathy).
• Numbness, itching, and pins-and-needles sensation on the skin (paraesthesia).
• Dizziness, difficulty standing up and moving normally.
• Swelling due to fluid accumulation.
• 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 short of breath, and you 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 fatigue, generalised weakness, muscle cramps, irritability, and may lead to low calcium levels in the blood (hypocalcaemia), possibly causing numbness and/or tingling in the 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 weakness of the skeletal muscles.
• High levels of potassium in the blood, which may cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause fatigue 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.
• Abnormalities in 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, leading to 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 fatigue, 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 G.L. Pharma

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 the
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 G.L. Pharma if you notice damage or signs of tampering with the
medicine packaging.
Do not dispose of any medicines via wastewater or household waste. Unused medicines 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 G.L. Pharma contains

• The active substance is pomalidomide.
• The other ingredients are mannitol (E421), pregelatinized starch, and sodium stearyl fumarate.

Pomalidomide G.L. Pharma 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 G.L. Pharma 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 G.L. Pharma 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), indigo carmine (E132), and white ink.
• The printing ink contains: shellac, titanium dioxide (E171), propylene glycol.

Pomalidomide G.L. Pharma 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), indigo carmine (E132), erythrosine (E127), and white ink.
• The printing ink contains: shellac, titanium dioxide (E171), propylene glycol.

Description of the appearance of Pomalidomide G.L. Pharma and contents of the pack
Pomalidomide G.L. Pharma 1 mg hard capsules: hard gelatin capsules,
with a yellow body and red cap, marked with "PLM 1" printed axially and rectified
in white on the body.
Pomalidomide G.L. Pharma 2 mg hard capsules: hard gelatin capsules,
with an orange body and red cap, marked with "PLM 2" printed axially and
rectified in white on the body.
Pomalidomide G.L. Pharma 3 mg hard capsules: hard gelatin capsules,
with a turquoise body and red cap, marked with "PLM 3" printed axially and
rectified in white on the body.
Pomalidomide G.L. Pharma 4 mg hard capsules: hard gelatin capsules,
with a dark blue body and red cap, marked with "PLM 4" printed axially and
rectified in white on the body.
Each pack contains 14, 21, 14x1 or 21x1 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
G.L. Pharma GmbH
Schlossplatz 1, 8502 Lannach,
Austria

Manufacturer
Synthon Hispania,
S.L., Calle De Castello 1,
Sant Boi de Llobregat,
Barcelona, 08830, Spain
Synthon B.V.,
Microweg 22, 6545 CM,
Nijmegen, The Netherlands
G.L. Pharma GmbH,
Industriestrasse 1,
Lannach, Styria,
8502, Austria

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands Pomalidomide G.L. 1 mg, harde capsules
Pomalidomide G.L. 2 mg, harde capsules
Pomalidomide G.L. 3 mg, harde capsules
Pomalidomide G.L. 4 mg, harde capsules
Austria Pomalidomid G.L. 1 mg-Hartkapseln
Pomalidomid G.L. 2 mg-Hartkapseln
Pomalidomid G.L. 3 mg-Hartkapseln
Pomalidomid G.L. 4 mg-Hartkapseln
Italy Pomalidomide G.L. Pharma