IMNOVID 1 mg Hard Capsule

Зміст інструкції

1. Imnovid 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
   1. What is Imnovid and what is it used for
   2. What you need to know before taking Imnovid
   3. How to take Imnovid
   4. Possible side effects
   5. How to store Imnovid
   6. Package contents and other information

Imnovid 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide

It is expected that Imnovid will cause congenital malformations 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 you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur,
• including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Imnovid and what is it used for

What is Imnovid
Imnovid 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 is Imnovid used for
Imnovid is used in the treatment of adults with a type of cancer called “multiple myeloma”.
Imnovid 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

• another medicine, called “dexamethasone”, in patients in whom the 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 certain period of time. When this happens, it is referred to as “response”.

How does Imnovid work
Imnovid works in several ways:

• stopping the growth 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 Imnovid together with bortezomib and dexamethasone
When Imnovid 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, Imnovid, 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 Imnovid together with dexamethasone
When Imnovid is used together with dexamethasone, in patients who have received at least two other therapies,
it can prevent multiple myeloma from worsening:

• On average, Imnovid, 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 Imnovid

Do not take Imnovid

• If you are pregnant or think you may be pregnant, or if you are planning a pregnancy, as Imnovid is expected to harm the fetus. (Men and women taking this medicine should read the “Pregnancy, contraception and breastfeeding – information for women and men” section below).
• If there is a possibility that you may 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 may become pregnant, on each prescription the 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 if any of the above conditions apply to you, consult your doctor, pharmacist or nurse before taking Imnovid.

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

• you have had episodes of blood clots in the past. During treatment with Imnovid there is a higher 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 Imnovid to reduce the likelihood of blood clots forming;
• 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 Imnovid can 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 severe 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 evaluate 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 sensation, memory loss or confusion. These can 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 Imnovid, inform 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 Imnovid Pregnancy Prevention Program.
Women and men taking Imnovid must not start a pregnancy or conceive a child, as pomalidomide is expected to harm the fetus. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Imnovid if you are currently pregnant, if you suspect or are planning a pregnancy, as this medicine is expected to harm the fetus. Before starting treatment, you must inform your doctor if there is a possibility of 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, throughout the 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 make sure that you understand what measures you need to take to prevent pregnancy.
• The doctor will arrange for 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 Imnovid 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
Imnovid passes into human seminal fluid.

• If your partner is pregnant or there is a possibility that she may become pregnant, you must use condoms throughout the duration of treatment and for 7 days after the end of treatment.
• If your partner becomes pregnant during treatment with Imnovid, 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 Imnovid you will undergo regular blood tests, as 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 duration of treatment with Imnovid.

Based on the results of these tests, your doctor may adjust the dose of Imnovid or stop treatment. The doctor may also adjust the dose or stop treatment based on your overall health status.

Children and adolescents
The use of Imnovid is not recommended in children and adolescents under 18 years of age.

Other medicines and Imnovid
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Imnovid can affect the way other medicines work and other medicines can affect the way Imnovid works.
In particular, tell your doctor, pharmacist or nurse before taking Imnovid 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 alertness when taking Imnovid. If this happens, do not drive vehicles and do not use tools or machinery.

Imnovid contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take Imnovid

Imnovid must be administered by a doctor experienced in the treatment of multiple myeloma.
Take the medicines following the doctor's instructions exactly. If you have any doubts, consult your
doctor, pharmacist or nurse.

When to take Imnovid with other medicines
Imnovid with bortezomib and dexamethasone
use and their effects.

• Imnovid, 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. IMN:Imnovid; BOR: Bortezomib; DEX: Dexamethasone

Cycle 1 to 8From Cycle 9 onwards
Name of the medicineName of the medicine
DayIMNBORDEXDay-IMNBORDEX
nono
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.

Imnovid with dexamethasone alone
its effects.

• Imnovid 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.

IMN:Imnovid; DEX: Dexamethasone

Name of the
medicine
Day-IMNDEX
no
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 Imnovid to be taken with other medicines
Imnovid with bortezomib and dexamethasone

• The recommended initial dose of Imnovid 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.

Imnovid with dexamethasone alone

• The recommended initial dose of Imnovid 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 Imnovid, bortezomib or dexamethasone or stop one
or more of these medicines based on the results of blood tests, your general condition,
other medicines you are taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if
adverse 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 Imnovid

• 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.
• The capsules can be taken with or without food.
• Take the capsules every day at approximately the same time.

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

The doctor will inform you how and when to take Imnovid if you have kidney problems and are
undergoing dialysis.

Duration of treatment with Imnovid
You must continue the treatment cycles until the doctor tells you to stop the treatment

If you take more Imnovid than you should
If you take more Imnovid than you should, consult your doctor or go to hospital immediately. Bring
the medicine packaging with you.

If you forget to take Imnovid
If you forget to take Imnovid 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 forgetting to
take Imnovid the previous day.
If you have any questions 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 Imnovid 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 ulcers, 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, fast heartbeat, 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 the lower leg or calf (caused by blood clots).
• Shortness of breath (due to a serious lung 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 Imnovid, 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 in 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 see your doctor or seek medical attention immediately. See also section 2.

Stop taking Imnovid 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 (hypokalemia), which can 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).
• Loss of 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 during urination 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 radiating to the arms, neck, jaw, sweating, and shortness of breath, nausea or vomiting).
• Chest pain, lung infection.
• Increased blood pressure.
• Simultaneous reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia) which makes you more prone to bleeding and bruising. You may feel tired, weak, and short 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 lead to a lowering of 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 weakness of skeletal muscles.
• 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 cancer cells, causing the release of toxic substances 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 Imnovid

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 on the package after
Expiry/EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use Imnovid if you notice damage or signs of tampering with the medicine packaging.
Do not dispose of any medicine in wastewater or household waste. Unused medicine
should be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Package contents and other information

What Imnovid contains

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

Imnovid 1 mg hard capsules:

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172) and white and black ink.
• The inscription ink contains: shellac, titanium dioxide (E171), simethicone, propylene glycol (E1520) and ammonium hydroxide (E527) (white ink) and shellac, black iron oxide (E172), propylene glycol (E1520) and ammonium hydroxide (E527) (black ink).

Imnovid 2 mg hard capsules:

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172), erythrosine (E127) and white ink.
• The inscription ink contains: white ink - shellac, titanium dioxide (E171), simethicone, propylene glycol (E1520) and ammonium hydroxide (E527).

Imnovid 3 mg hard capsules:

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172) and white ink.
• The inscription ink contains: white ink - shellac, titanium dioxide (E171), simethicone, propylene glycol (E1520) and ammonium hydroxide (E527).

Imnovid 4 mg hard capsules:

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), brilliant blue FCF (E133) and white ink.
• The inscription ink contains: white ink - shellac, titanium dioxide (E171), simethicone, propylene glycol (E1520) and ammonium hydroxide (E527).

Description of the appearance of Imnovid and contents of the pack
Imnovid 1 mg hard capsules: opaque dark blue cap and opaque yellow body, bearing the inscription “POML
1 mg”.
Imnovid 2 mg hard capsules: opaque dark blue cap and opaque orange body, bearing the inscription “POML
2 mg”.
Imnovid 3 mg hard capsules: opaque dark blue cap and opaque green body, bearing the inscription “POML
3 mg”.
Imnovid 4 mg hard capsules: opaque dark blue cap and opaque light blue body, bearing the inscription “POML
4 mg”.
Each pack contains 14 or 21 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Manufacturer
Celgene Distribution B.V.
Orteliuslaan 1000
3528 BD Utrecht
Netherlands
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Lietuva
Swixx Biopharma UAB
Tel: + 370 52 369140
[email protected]

България
Swixx Biopharma EOOD
Teл.: + 359 2 4942 480
[email protected]

Luxembourg/Luxemburg
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Česká republika
Bristol-Myers Squibb spol. s r.o.
Tel: + 420 221 016 111
[email protected]

Magyarország
Bristol-Myers Squibb Kft.
Tel.: + 36 1 301 9797
[email protected]

Danmark
Bristol-Myers Squibb Denmark
Tlf: + 45 45 93 05 06
[email protected]

Malta
A.M. Mangion Ltd
Tel: + 356 23976333
[email protected]

Deutschland
Bristol-Myers Squibb GmbH & Co. KGaA
Tel: 0800 0752002 (+ 49 89 121 42 350)
[email protected]

Nederland
Bristol-Myers Squibb B.V.
Tel: + 31 (0)30 300 2222
[email protected]

Eesti
Swixx Biopharma OÜ
Tel: + 372 640 1030
[email protected]

Norge
Bristol-Myers Squibb Norway AS
Tlf: + 47 67 55 53 50
[email protected]

Ελλάδα
Bristol-Myers Squibb A.E.
Τηλ: + 30 210 6074300
[email protected]

Österreich
Bristol-Myers Squibb GesmbH
Tel: + 43 1 60 14 30
[email protected]

España
Bristol-Myers Squibb, S.A.
Tel: + 34 91 456 53 00
[email protected]

Polska
Bristol-Myers Squibb Polska Sp. z o.o.
Tel.: + 48 22 2606400
[email protected]

France
Bristol-Myers Squibb SAS
Tél: + 33 (0)1 58 83 84 96
[email protected]

Portugal
Bristol-Myers Squibb Farmacêutica Portuguesa,
S.A.
Tel: + 351 21 440 70 00
[email protected]

Hrvatska
Swixx Biopharma d.o.o.
Tel: + 385 1 2078 500
[email protected]

România
Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 40 (0)21 272 16 19
[email protected]

Ireland
Bristol-Myers Squibb Pharmaceuticals uc
Tel: 1 800 749 749 (+ 353 (0)1 483 3625)
[email protected]

Slovenija
Swixx Biopharma d.o.o.
Tel: + 386 1 2355 100
[email protected]

Ísland
Vistor ehf.
Sími: + 354 535 7000
[email protected]

Slovenská republika
Swixx Biopharma s.r.o.
Tel: + 421 2 20833 600
[email protected]

Italia
Bristol-Myers Squibb S.r.l.
Tel: + 39 06 50 39 61
[email protected]

Suomi/Finland
Oy Bristol-Myers Squibb (Finland) Ab
Puh/Tel: + 358 9 251 21 230
[email protected]

Κύπρος
Bristol-Myers Squibb A.E.
Τηλ: 800 92666 (+ 30 210 6074300)
[email protected]

Sverige
Bristol-Myers Squibb Aktiebolag
Tel: + 46 8 704 71 00
[email protected]

Latvija
Swixx Biopharma SIA
Tel: + 371 66164750
[email protected]

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu. Links to other websites on rare diseases and related therapeutic treatments are also provided.
Detailed information on this medicine is also available by scanning the QR code on the secondary packaging with a smartphone. The same information is
available at: www.imnovid-eu-pil.com.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
Taking into account the assessment of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the final report of the non-interventional post-authorisation safety study (PASS) mandated for the above-mentioned medicine,
the scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:
The CC-4047-MM-015 study was a condition for the marketing authorisation and, therefore, Annex II must be updated, as the study has been completed. Furthermore, the pregnancy reporting form has been removed from the Healthcare Professional Educational Booklet.
Therefore, in consideration of the available data regarding the final PASS study report, the PRAC concluded that the changes to the conditions of the marketing authorisation
are justified.
The PRAC considered the updated Risk Management Plan (RMP) acceptable.
The CHMP agrees with the scientific conclusions of the PRAC.

Justification for variation of the terms of the marketing authorisation
Based on the scientific conclusions on the results of the study for the above-mentioned medicine,
the CHMP considers that the benefit-risk ratio of this medicine remains unchanged, subject to the
proposed changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation for the
above-mentioned medicine.