Pomalidomide Viatris

Package leaflet: Information for the patient

Pomalidomide Viatris 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide
Pomalidomide Viatris is expected to cause birth defects and may result in fetal death.

• Do not take this medicine if you are pregnant or may 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 other people, even if they have the same symptoms as you, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

What Pomalidomide Viatris is
Pomalidomide Viatris 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 Viatris is used for
Pomalidomide Viatris is used to treat adults with a type of cancer called “multiple myeloma”.
Pomalidomide Viatris 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 containing lenalidomide. or
• one other medicine, called “dexamethasone”, in patients whose multiple myeloma has worsened despite at least two prior therapies containing 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 Viatris works
Pomalidomide Viatris 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 Viatris together with bortezomib and dexamethasone
When pomalidomide 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 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 Viatris together with dexamethasone
When pomalidomide 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 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 Viatris

Do not take Pomalidomide Viatris

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Pomalidomide Viatris 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 possibility 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 possibility 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 are allergic, consult your doctor.

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

• You have previously had episodes of blood clots. There is an increased risk of developing blood clots in the veins (thrombosis) and arteries during treatment with Pomalidomide Viatris. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Viatris 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 medicines related to pomalidomide 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 may result in 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 Viatris 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.
At any time during or after treatment, inform your doctor or nurse immediately if you experience blurred vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, changes in the way you walk, balance problems, 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 Viatris, 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 specified in the Pomalidomide Viatris Pregnancy Prevention Programme. Women and men taking Pomalidomide Viatris must not become pregnant or father a child, because pomalidomide is expected to be harmful to the unborn baby. You and your partner must use effective contraception during treatment with this medicine.
Women
Do not take Pomalidomide Viatris 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 possibility you could become pregnant, even if you think it is unlikely.
If there is any possibility you could become pregnant:

• You must use effective contraceptive methods for at least 4 weeks before starting treatment, throughout the treatment period, 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 immediately.

Breastfeeding
It is not known whether Pomalidomide Viatris passes into breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will advise you whether to stop or continue breastfeeding.
Men
Pomalidomide Viatris passes into human seminal fluid.

• If your partner is pregnant or there is a possibility 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 Viatris, 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 Viatris, you will have 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 starting treatment
• Weekly for the first 8 weeks of treatment
• At least once a month thereafter, throughout the duration of treatment with Pomalidomide Viatris.

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

Pomalidomide Viatris must be administered by a physician experienced in the treatment of multiple myeloma.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.

When to take Pomalidomide Viatris with other medicines
Pomalidomide Viatris with bortezomib and dexamethasone

• Read the package leaflet of bortezomib and dexamethasone for more information on their use and effects.
• Pomalidomide Viatris, bortezomib, and dexamethasone are taken in “treatment cycles”. Each cycle lasts 21 days (3 weeks).
• Refer to the table below to know which medicines to take each day of the 3-week cycle: o Each day, check the chart and find the correct day to determine which medicines to take. o On some days, you will take all three medicines; on other days, only two or one medicine; and on some days, no medicine at all.

POM: Pomalidomide Viatris; 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 Viatris with dexamethasone alone

• Refer to the dexamethasone package leaflet for more information on its use and effects.
• Pomalidomide Viatris and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Refer to the table below to know which medicines to take each day of the 4-week cycle: o Each day, check the chart and find the correct day to determine which medicines to take.

o On some days, you will take both medicines; on other days, only one medicine; and on some days, no medicine at all.
POM: Pomalidomide Viatris; 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 Viatris to be taken with other medicines
Pomalidomide Viatris with bortezomib and dexamethasone

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

• The recommended starting dose of Pomalidomide Viatris 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 Viatris, 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 any adverse effects occur (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 Viatris

• 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.
• The capsules may be taken with or without food.
• Take Pomalidomide Viatris 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 it may break.

Your doctor will inform you how and when to take Pomalidomide Viatris if you have kidney problems and are undergoing dialysis.

Duration of treatment with Pomalidomide Viatris
You must continue the treatment cycles until your doctor tells you to stop.

If you take more Pomalidomide Viatris than you should
If you take more Pomalidomide Viatris than prescribed, consult your doctor or go to hospital immediately. Take the medicine packaging with you.

If you forget to take Pomalidomide Viatris
If you forget to take Pomalidomide Viatris 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 Viatris on the previous day.

If you have any doubts 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 everybody gets them.

Serious side effects

Stop taking Pomalidomide Viatris 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 reason, including nosebleeds and bleeding from the intestine or stomach (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 Viatris, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, 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 Viatris and contact your doctor immediately if you experience any of the serious side effects listed above: 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 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 spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or burning sensation on the skin, pain in the 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 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 system damage (peripheral sensory-motor neuropathy).
• Numbness, itching, and prickling or "pins and needles" sensation on the skin (paraesthesia).
• Dizziness, with difficulty standing up and moving normally.
• Swelling caused by 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 the number of red blood cells, white blood cells, and platelets (pancytopenia), increasing the risk of bleeding and bruising. You may feel tired, weak, and breathless, and you may be more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability, and may lead to low levels of calcium 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 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.
• Swollen abdomen.
• 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 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pomalidomide Viatris

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 pack and carton after
Exp/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 with the packaging.
Do not dispose of any medicine via wastewater or household waste. Unused medicine must be returned to your pharmacist at the end of treatment. This will help protect the environment.

6. Package Contents and Other Information

What Pomalidomide Viatris Contains

• The active substance is pomalidomide.
• The other ingredients are pregelatinized starch, anhydrous colloidal silica, magnesium stearate, mannitol, and sodium croscarmellose.
• The printing ink contains: shellac, black iron oxide (E172), propylene glycol, and ammonium hydroxide.

Pomalidomide Viatris 1 mg hard capsule:

• Each capsule contains 1 mg of pomalidomide. The capsule shell contains: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and indigo carmine (E132).

Pomalidomide Viatris 2 mg hard capsule:

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and indigo carmine (E132).

Pomalidomide Viatris 3 mg hard capsule:

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), and indigo carmine (E132).

Pomalidomide Viatris 4 mg hard capsule:

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), and indigo carmine (E132).

Description of the Appearance of Pomalidomide Viatris and Contents of the Pack
Pomalidomide Viatris 1 mg hard capsules have an opaque blue cap and an opaque light yellow body,
marked with the inscription “VIATRIS” over “PM1”.
Pomalidomide Viatris 2 mg hard capsules have an opaque blue cap and an opaque light orange body,
marked with the inscription “VIATRIS” over “PM2”.
Pomalidomide Viatris 3 mg hard capsules have an opaque blue cap and an opaque light green body,
marked with the inscription “VIATRIS” over “PM3”.
Pomalidomide Viatris 4 mg hard capsules have an opaque blue cap and an opaque light blue body,
marked with the inscription “VIATRIS” over “PM4”.
Pomalidomide Viatris is supplied in blister packs containing 14 or 21 hard capsules, or in perforated blister strips containing 14x1 or 21x1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer(s)
Mylan Hungary Kft. / Mylan Hungary Ltd.
Mylan Utca 1
Komárom
Hungary
Mylan Germany GmbH
Benzstrasse 1
Bad Homburg
61352,
Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien Lietuva*
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark* Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L.U. Mylan Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0)2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: +357 2220 7700 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Additional Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

ANNEX IV
CONCLUSIONS ON SIMILARITY AND DEROGATION FROM SIMILARITY
PRESENTED BY THE EUROPEAN MEDICINES AGENCY

Conclusions presented by the European Medicines Agency on:

• Similarity The Committee for Medicinal Products for Human Use (CHMP) considers that Pomalidomide Viatris is similar to the already authorized orphan medicinal product(s) under Article 3 of Regulation (EC) No 847/2000, as further described in the European Public Assessment Report (EPAR).
• Derogation The Committee for Medicinal Products for Human Use (CHMP) considers that, under Article 8 of Regulation (EC) No 141/2000, the following derogations defined in Article 8(3) of Regulation (EC) No 141/2000 apply, as further described in the European Public Assessment Report (EPAR): the marketing authorization holder of Imnovid has provided consent to the applicant.