POMALIDOMIDE 4 mg Hard Capsules

Зміст інструкції

1. Pomalidomide Viatris 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
   1. What is Pomalidomide Viatris and what is it 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

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 cause fetal death.

• Do not take this medicine if you are pregnant or might become pregnant.
• Follow the advice on contraceptive methods described in this leaflet.

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Pomalidomide Viatris and what is it used for

What is Pomalidomide Viatris
Pomalidomide Viatris contains the active ingredient “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 is Pomalidomide Viatris used for
Pomalidomide Viatris is used in the treatment of adults with a type of cancer called
“multiple myeloma”.
Pomalidomide Viatris is used together with:

• two other medicines, called “bortezomib” (a type of chemotherapeutic medicine) and “dexamethasone” (an anti-inflammatory medicine), in patients who have received at least one other therapy including lenalidomide. or
• one other medicine, called “dexamethasone”, in patients in whom the multiple myeloma has worsened despite at least two other 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 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 period of time. When this happens, it is referred to as “response”.

How does Pomalidomide Viatris work
Pomalidomide Viatris works in several ways:

• stopping the development of myeloma cells
• stimulating the immune system to attack cancer cells
• stopping the formation of blood vessels that feed 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 other therapy, it can prevent multiple myeloma from worsening:

• On average, pomalidomide, used with bortezomib and dexamethasone, prevented the recurrence of multiple myeloma for a period of up to 11 months, compared to 7 months for 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 other
therapies, it can prevent multiple myeloma from worsening:

• On average, pomalidomide, used with dexamethasone, prevented the recurrence of multiple myeloma for a period of up to 4 months, compared to 2 months for patients treated with dexamethasone alone.

2. What you need to know before taking Pomalidomide Viatris

Do not takePomalidomide Viatris

• If you are pregnant or if you think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Viatris is expected to harm the fetus. (Men and women taking this medicine must read the paragraph “Pregnancy, contraception and breastfeeding – information for women and men” below).
• If there is a possibility that you might become pregnant unless you follow all the necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is a possibility that you might become pregnant, on each prescription your doctor will record that the necessary measures have been taken and will provide you with this 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 may be allergic, ask your doctor for advice.

If you are not sure whether any of the above conditions apply to you, consult your doctor, your
pharmacist or your nurse before taking Pomalidomide Viatris.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pomalidomide Viatris if:

• you have had episodes of blood clots in the past. During treatment with Pomalidomide Viatris there is a higher risk of blood clots forming in veins (thrombosis) and arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Viatris to reduce the likelihood of blood clots forming;
• if you have had an allergic reaction in the past, such as rash, itching, swelling, dizziness or difficulty breathing, during treatment with related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels;
• you have a high tumor burden throughout the body, including in the bone marrow. This could cause a condition in which tumors break down and cause the presence of unusual levels of

chemicals in the blood, which can lead to kidney failure. An irregular heartbeat may also appear.
This condition is called tumor lysis syndrome;

• you have or have had neuropathy (nerve damage that causes tingling or pain in the hands or feet).
• you have or have had hepatitis B infection in the past. Treatment with Pomalidomide Viatris may cause reactivation of the hepatitis B virus in patients carrying this virus, resulting in a recurrence of the infection. Your doctor should check if you have ever had a hepatitis B infection.
• you have or have had any combination of the following symptoms: rash on the face or more widespread, 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, the doctor must carefully assess the benefit and risk when
prescribing this medicine.
At any time during or after treatment, immediately inform your doctor or nurse
if you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an
arm or leg, changes in the way you walk or problems with balance, persistent numbness, reduced
sensation or loss of feeling, 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 treatment
with Pomalidomide Viatris, tell your doctor of any changes in these symptoms.
At the end of 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 Viatris Pregnancy
Prevention Program. Women and men taking Pomalidomide Viatris must not
start a pregnancy or conceive 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 Viatris if you are currently pregnant, if you suspect 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 a possibility of you becoming pregnant, even
if you think it is unlikely.
If there is a possibility of becoming pregnant:

• you must use effective contraceptive methods for at least 4 weeks before starting treatment, for the entire duration of treatment and for at least 4 weeks after stopping treatment. Consult your doctor about the best contraceptive method for you.
• On each prescription, the doctor will ensure that you understand what measures need to be taken to prevent pregnancy.
• The doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment and at least 4 weeks after the end of treatment.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and consult your doctor immediately

Breastfeeding
It is not known whether Pomalidomide Viatris passes into breast milk. Tell your doctor if you are breastfeeding or
intend 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 that she might become pregnant, you must use condoms for the entire duration of treatment and for 7 days after the end of treatment.
• If your partner becomes pregnant during treatment with Pomalidomide Viatris, inform your doctor immediately. Your partner should also inform her doctor immediately.

You must not donate seminal fluid or sperm during treatment and for 7 days after the end of
treatment.

Blood donation and blood tests
You must not donate blood during treatment and for 7 days after the end of treatment.
Before and during treatment with Pomalidomide Viatris you will undergo regular blood tests,
because this medicine can cause a reduction in blood cells that fight
infections (white blood cells) and cells that stop bleeding (platelets).
The doctor will ask you to undergo blood tests:

• before treatment
• every week for the first 8 weeks of treatment
• at least once a month thereafter, for the entire period of treatment with Pomalidomide Viatris.

Based on the results of these tests, your doctor may change the dose of Pomalidomide Viatris or
stop treatment. The doctor may also change the dose or stop treatment based on your overall health.
state.

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
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. This is because Pomalidomide Viatris can affect the action of
other medicines and other medicines can affect the action of Pomalidomide Viatris.
In particular, tell your doctor, pharmacist or nurse before taking Pomalidomide Viatris
if you are taking any of the following medicines:

• some antifungal medicines, such as ketoconazole
• some antibiotics (e.g. ciprofloxacin, enoxacin)
• some antidepressants, such as fluvoxamine.

Driving and using machines
Some people may experience fatigue, dizziness, feeling faint, confusion or reduced
vigilance when taking Pomalidomide Viatris. If this happens, do not drive vehicles and do not use
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 doctor experienced in the treatment of multiple myeloma.
Take the medicine following the doctor's instructions exactly. 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
use and their effects.

• Pomalidomide Viatris, bortezomib and dexamethasone are taken in “treatment cycles”. Each cycle lasts 21 days (3 weeks).
• Consult the following table to find out what to take each day of the 3-week cycle: o Every day check the chart and find the correct day to know which medicines to take. o Some days you will take all 3 medicines, some days only 2 or 1 medicine and other days no medicine.

POM:Pomalidomide Viatris; BOR: Bortezomib; DEX: Dexamethasone

Cycle 1 to 8From Cycle 9 onwards
Name of the medicine
DayPOMBORDEX
1 √ √ √
2 √ √
3 √
4 √ √ √
5 √ √
6 √
7 √
8 √ √ √
9 √ √
10 √
11 √ √ √
12 √ √
13 √
14 √
15
16
17
18
19
20
21

Name of the medicine
DayPOMBORDEX
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 Viatris with dexamethasone alone
its effects.

• Pomalidomide Viatris and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Consult the following table to find out what to take each day of the 4-week cycle: o Every day check the chart and find the correct day to know which medicines to take.

o Some days you will take both medicines, some days only 1 medicine and other days
no medicine.

POM:Pomalidomide Viatris; DEX: Dexamethasone

Name of the
medicine
DayPOMDEX
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 Viatris to be taken with other medicines
Pomalidomide Viatris with bortezomib and dexamethasone

• The recommended initial dose of Pomalidomide Viatris is 4 mg once a day.
• The recommended initial dose of bortezomib will be established by the doctor based on your height and weight (1.3 mg/m of body surface area).
• The recommended initial dose of dexamethasone is 20 mg per day. However, if you are over 75 years of age, the recommended initial dose is 10 mg per day.

Pomalidomide Viatris with dexamethasone alone

• The recommended initial dose of Pomalidomide Viatris is 4 mg once a day.
• The recommended initial dose of dexamethasone is 40 mg per day. However, if you are over 75 years of age, the recommended initial dose is 20 mg per day.

The doctor may need to reduce the dose of Pomalidomide Viatris, bortezomib or dexamethasone or
interrupt 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 undesirable effects (in particular skin rash or swelling) occur due to
treatment.
If you have liver or kidney problems, the doctor will monitor your condition very carefully
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 water and soap.
• Healthcare professionals, those providing assistance to the patient and family members must wear disposable gloves when handling the blister or capsule. The gloves should then be removed carefully to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Pregnant or suspected pregnant women should not handle the blister or capsule.
• Swallow the tablets whole, preferably with water.
• Capsules can be taken with or without food.
• Take Pomalidomide Viatris every day at approximately the same time.

To remove the capsule from the blister, press on one side of the capsule only, pushing it through the
aluminium foil. Do not press on the centre of the capsule, otherwise there is a risk of breaking it.

The 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 the doctor tells you to stop the treatment

If you take more Pomalidomide Viatris than you should
If you take more Pomalidomide Viatris than you should, consult your doctor or go to hospital
immediately. Bring 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 next day. Do not increase the number of capsules to be taken to compensate for the
omission of Pomalidomide Viatris the previous day.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
Stop taking Pomalidomide Viatris and consult your doctor immediately if you experience any of the
following serious side effects – urgent medical treatment may be needed:

• Fever, chills, sore throat, cough, mouth sores, or any other sign of infection (due to a lower number of white blood cells, which fight infections).
• Bleeding or bruising easily, including nosebleeds and bleeding from the intestine or stomach (due to effects on blood cells called “platelets”).
• Rapid breathing, rapid pulse, fever and chills, decreased or absent urination, nausea and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhea (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 can 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 can cause changes in the appearance or growths on the skin. If you notice any skin changes during treatment with Pomalidomide Viatris, tell your doctor as soon as possible.
• Reappearance of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, and nausea or vomiting. Tell your doctor immediately if you notice any of these symptoms.
• Widespread rash, high temperature, swollen lymph nodes, and involvement of other organs of the body (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 seek your doctor’s advice or immediate medical attention. See also section 2.

Stop taking Pomalidomide Viatris and consult your doctor immediatelyif you experience any of the
serious side effects listed above: urgent medical treatment may be needed.

Other side effects
Very common(may affect more than 1 in 10 people):

• Shortness of breath (dyspnea).
• 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 can cause anemia with resulting fatigue and weakness.
• Low levels of potassium in the blood (hypokalaemia), which can cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
• High levels of sugar in the blood.
• Fast and irregular heartbeat (atrial fibrillation).
• Decreased appetite.
• Constipation, diarrhea, 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 the hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including swelling of the arms and legs.
• Skin rashes.
• Urinary tract infection, which can cause a burning sensation when urinating or the need to urinate more often.

Common(may affect up to 1 in 10 people):

• Falls.
• Bleeding inside the skull.
• Reduced ability to move or feel sensations in the hands, arms, feet, and legs due to damage to the nervous system (peripheral sensorimotor neuropathy).
• Numbness, itching, and pins and needles sensation on the skin (paresthesia).
• Feeling dizzy, with difficulty getting up and moving normally.
• Swelling caused by fluid.
• Hives.
• Itching.
• Shingles (herpes zoster).
• Heart attack (chest pain that radiates to the arms, neck, jaw, sweating, and 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) which makes you more susceptible to bleeding and bruising. You may experience fatigue, weakness, and shortness of breath and are also more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cells) often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesemia), which can cause fatigue, generalized weakness, muscle cramps, irritability, and can cause a decrease in calcium levels in the blood (hypocalcemia), with possible numbness and/or tingling of the hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion.
• High levels of calcium in the blood (hypercalcemia), which can cause slowed reflexes and skeletal muscle weakness.
• High levels of potassium in the blood, which can cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which can cause fatigue and confusion, muscle spasms, seizures, or coma.
• High levels of uric acid in the blood, which can cause a form of arthritis called gout.
• Low blood pressure, which can cause dizziness or fainting.
• Painful or dry mouth.
• Altered sense of taste.
• Bloated abdomen.
• Feeling confused.
• Feeling down (depressed mood)
• Loss of consciousness, fainting.
• Blurred vision (cataracts).
• 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 can cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Disintegration of tumor cells, which causes the release of toxic compounds into the bloodstream (tumor lysis syndrome). This can cause kidney problems.
• Thyroid gland not sufficiently active, which can cause symptoms such as fatigue, lethargy, muscle weakness, slow heartbeat, and weight gain.

Not known(frequency cannot be estimated based on available data):

• Rejection of solid organ transplant (such as heart or liver).

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through 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 and the package after
Exp/EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice damage or signs of tampering with the packaging of the
medicine.
Do not dispose of any medicine in wastewater or household waste. Unused medicine
should be returned to your pharmacist at the end of treatment. This will help protect
the environment.

6. Contents of the pack and other information

What Pomalidomide Viatris contains

• The active ingredient is pomalidomide.
• The other ingredients are pregelatinized starch, anhydrous colloidal silica, magnesium stearate, mannitol and sodium croscarmellose.
• The ink of the lettering contains: lac resin, 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,
bearing the inscription “VIATRIS” on “PM1”.
Pomalidomide Viatris 2 mg hard capsules have an opaque blue cap and an opaque light orange body,
bearing the inscription “VIATRIS” on “PM2”.
Pomalidomide Viatris 3 mg hard capsules have an opaque blue cap and an opaque light green body,
bearing the inscription “VIATRIS” on “PM3”.
Pomalidomide Viatris 4 mg hard capsules have an opaque blue cap and an opaque light blue body, bearing the
inscription “VIATRIS” on “PM4”.
Pomalidomide Viatris is supplied in blister packs of 14 or 21 hard capsules or in perforated blister packs
of 14x1 or 21x1 hard capsules.
Not all pack sizes may be marketed.

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

Manufacturer(s)
Mylan Hungary Kft. / Mylan Hungary Ltd.
Mylan Utca 1
Komárom
2900
Hungary
Mylan Germany GmbH
Benzstrasse 1
Bad Homburg
61352,
Germany
For further information on this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva*
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: + 420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark*
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

España
Viatris Pharmaceuticals, S.L.U.
Tel: + 34 900 102 712

Polska
Mylan Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Mylan Ireland Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 (0)2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
Varnavas Hadjipanayis Ltd
Τηλ: +357 2220 7700

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu .

ANNEX IV
CONCLUSIONS RELATING TO SIMILARITY AND DEROGATION FROM SIMILARITY
PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Conclusions presented by the European Medicines Agency on:

• SimilarityThe Committee for Medicinal Products for Human Use ( Committee for Human Medicinal Products,CHMP) considers that Pomalidomide Viatris is similar to the authorised orphan medicinal product(s) under Article 3 of Regulation 847/2000/EC, as further described in the European Public Assessment Report ( European Public Assessment Report, EPAR).
• DerogationThe Committee for Medicinal Products for Human Use ( Committee for Human Medicinal Products,CHMP) considers that, pursuant to Article 8 of Regulation 141/2000/EC ,the following derogations as defined in Article 8(3) of Regulation 141/2000/EC apply, as further described in the European Public Assessment Report ( European Public Assessment Report, EPAR): the marketing authorisation holder of Imnovid has provided consent to the applicant.