Imnovid

Patient information leaflet

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

pomalidomide
Imnovid 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 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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects,
  including those not listed in this leaflet, inform 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 taking 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 Imnovid is and what it is used for

What Imnovid is
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 Imnovid is used for
Imnovid is used to treat adults with a type of cancer called "multiple myeloma".

Imnovid 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 myeloma has worsened despite having received at least two prior therapies containing lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain kind 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 Imnovid works
Imnovid works in several ways:

• by stopping the growth of myeloma cells
• by stimulating the immune system to attack cancer cells
• by preventing the formation of blood vessels that supply nutrients to 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 prior therapy, it can prevent multiple myeloma from worsening:

• On average, Imnovid used with bortezomib and dexamethasone prevented the return of multiple myeloma for up to 11 months, compared to 7 months in 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 prior therapies, it can prevent multiple myeloma from worsening:

• On average, Imnovid used with dexamethasone prevented the return 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 Imnovid

Do not take Imnovid

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, because Imnovid 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 chance of becoming 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 of becoming pregnant, at each prescription your doctor will confirm that the necessary precautions have been taken and will provide you with written 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, 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 Imnovid.

Warnings and precautions

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

• You have previously had blood clots. There is an increased risk of developing blood clots in the veins (thrombosis) and arteries during treatment with Imnovid. Your doctor may recommend additional treatment (e.g. warfarin) or reduce your dose of Imnovid 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 related medicines called “thalidomide” or “lenalidomide”.
• You have had a heart attack, have heart failure, breathing difficulties, or if you smoke, have high blood pressure, or high cholesterol levels.
• You have a high tumour burden throughout your body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormally high levels of

chemicals in the blood, potentially leading to kidney failure. You may also experience irregular heart rhythm. 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 Imnovid may cause reactivation of the hepatitis B virus in patients carrying the virus, leading to a recurrence of 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 benefits and risks before 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, loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If you had these symptoms before starting Imnovid treatment, inform your doctor of any changes in these symptoms.

After completing treatment, return any unused capsules to your pharmacist.

Pregnancy, contraception and breastfeeding – information for women and men

The following instructions must be followed as outlined in the Imnovid Pregnancy Prevention Programme.

Women and men taking Imnovid 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 methods during treatment with this medicine.

Women

Do not take Imnovid if you are pregnant, think you may be pregnant, or are planning a pregnancy, because this medicine is expected to be harmful to the unborn baby. Before starting treatment, inform your doctor if there is any chance you could become pregnant, even if you think it is unlikely.

If there is any chance 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 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 contact your doctor right away.

Breastfeeding

It is not known whether Imnovid 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

Imnovid passes into human seminal fluid.

• If your partner is pregnant or there is any chance she could become pregnant, you must use condoms throughout the duration of treatment and for 7 days after stopping treatment.
• If your partner becomes pregnant during treatment with Imnovid, 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 Imnovid, you will undergo regular blood tests because this medicine may cause a reduction in blood cells that fight infections (white blood cells) and 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 Imnovid treatment.

Based on the results of these tests, your doctor may adjust your dose of Imnovid 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 Imnovid is not recommended in children and adolescents under 18 years of age.

Other medicines and Imnovid

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Imnovid may affect the action of other medicines, and other medicines may affect the action of Imnovid.

In particular, inform your doctor, pharmacist, or nurse before taking Imnovid 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 Imnovid. If this occurs, do not drive or operate tools or machinery.

Imnovid contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e., essentially ‘sodium-free’.

3. How to take Imnovid

Imnovid must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.

When to take Imnovid with other medicines

Imnovid with bortezomib and dexamethasone

• Read the package leaflet of bortezomib and dexamethasone for further information on their use and side effects.
• Imnovid, 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 some days only two or one medicine, and on other days no medicine at all.
  IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethasone

Cycles 1 to 8 From Cycle 9 onwards
Medicine name Medicine name
Day IMN BOR DEX Day IMN 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 cycle.

Imnovid with dexamethasone alone

• Read the package leaflet of dexamethasone for further information on its use and side effects.
• Imnovid 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 some days only one medicine, and on other days no medicine at all.

IMN: Imnovid; DEX: Dexamethasone
Medicine
Day IMN 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 cycle.

Recommended dose of Imnovid when taken with other medicines

Imnovid with bortezomib and dexamethasone

• The recommended starting dose of Imnovid 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.

Imnovid with dexamethasone alone

• The recommended starting dose of Imnovid 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 Imnovid, 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 side 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 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 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 women 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, press on one side of the capsule, pushing it through the aluminium foil. Do not press in the center of the capsule, as this may cause it to break.

Your 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 your doctor tells you to stop.

If you take more Imnovid than you should
If you take more Imnovid than prescribed, contact your doctor or go to a hospital immediately. Take the medicine package 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 following day. Do not increase the number of capsules to make up for the missed dose.

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 Imnovid and contact 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 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 called 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 Imnovid, 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 Imnovid 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 blood sugar levels.
• Fast 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 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 damage to the nervous system (peripheral sensory-motor neuropathy).
• Numbness, itching and pins and needles sensation on the skin (paraesthesia).
• Feeling of spinning (vertigo), with difficulty standing up and moving normally.
• Swelling caused by fluid retention.
• 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), which increases 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 cells), 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 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.
• Bloating of the 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, causing 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 the available data):

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system referred to 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 the outer 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 Imnovid if you notice damage or signs of tampering with the medicine packaging.
Do not dispose of any medicine via wastewater or household waste. Unused medicine must 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 substance is pomalidomide.
• The other components are mannitol (E421), starch, pregelatinized, and sodium stearyl fumarate.

Imnovid 1 mg hard capsule:

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

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

Imnovid 3 mg hard capsule:

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

Imnovid 4 mg hard capsule:

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigo carmine (E132), brilliant blue FCF (E133), and white ink.
• The imprint 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, marked with “POML 1 mg”.
Imnovid 2 mg hard capsules: opaque dark blue cap and opaque orange body, marked with “POML 2 mg”.
Imnovid 3 mg hard capsules: opaque dark blue cap and opaque green body, marked with “POML 3 mg”.
Imnovid 4 mg hard capsules: opaque dark blue cap and opaque light blue body, marked with “POML 4 mg”.
Each pack contains 14 or 21 capsules. Not all pack sizes may be marketed.

Marketing Authorization 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
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgique/België/Belgien Lietuva
N.V. Bristol-Myers Squibb Belgium S.A. Swixx Biopharma UAB
Tél/Tel: + 32 2 352 76 11 Tel: + 370 52 369140
[email protected] [email protected]

България Luxembourg/Luxemburg
Swixx Biopharma EOOD N.V. Bristol-Myers Squibb Belgium S.A.
Teл.: + 359 2 4942 480 Tél/Tel: + 32 2 352 76 11
[email protected] [email protected]

Česká republika Magyarország
Bristol-Myers Squibb spol. s r.o. Bristol-Myers Squibb Kft.
Tel: + 420 221 016 111 Tel.: + 36 1 301 9797
[email protected] [email protected]

Danmark Malta
Bristol-Myers Squibb Denmark A.M. Mangion Ltd
Tlf: + 45 45 93 05 06 Tel: + 356 23976333
[email protected] [email protected]

Deutschland Nederland
Bristol-Myers Squibb GmbH & Co. KGaA Bristol-Myers Squibb B.V.
Tel: 0800 0752002 (+ 49 89 121 42 350) Tel: + 31 (0)30 300 2222
[email protected] [email protected]

Eesti Norge
Swixx Biopharma OÜ Bristol-Myers Squibb Norway AS
Tel: + 372 640 1030 Tlf: + 47 67 55 53 50
[email protected] [email protected]

Ελλάδα Österreich
Bristol-Myers Squibb A.E. Bristol-Myers Squibb GesmbH
Τηλ: + 30 210 6074300 Tel: + 43 1 60 14 30
[email protected] [email protected]

España Polska
Bristol-Myers Squibb, S.A. Bristol-Myers Squibb Polska Sp. z o.o.
Tel: + 34 91 456 53 00 Tel.: + 48 22 2606400
[email protected] [email protected]

France Portugal
Bristol-Myers Squibb SAS Bristol-Myers Squibb Farmacêutica Portuguesa, S.A.
Tél: + 33 (0)1 58 83 84 96 Tel: + 351 21 440 70 00
[email protected] [email protected]

Hrvatska România
Swixx Biopharma d.o.o. Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 385 1 2078 500 Tel: + 40 (0)21 272 16 19
[email protected] [email protected]

Ireland Slovenija
Bristol-Myers Squibb Pharmaceuticals Ltd Swixx Biopharma d.o.o.
Tel: 1 800 749 749 (+ 353 (0)1 483 3625) Tel: + 386 1 2355 100
[email protected] [email protected]

Ísland Slovenská republika
Vistor ehf. Swixx Biopharma s.r.o.
Sími: + 354 535 7000 Tel: + 421 2 20833 600
[email protected] [email protected]

Italia Suomi/Finland
Bristol-Myers Squibb S.r.l. Oy Bristol-Myers Squibb (Finland) Ab
Tel: + 39 06 50 39 61 Puh/Tel: + 358 9 251 21 230
[email protected] [email protected]

Κύπρος Sverige
Bristol-Myers Squibb A.E. Bristol-Myers Squibb Aktiebolag
Τηλ: 800 92666 (+ 30 210 6074300) Tel: + 46 8 704 71 00
[email protected] [email protected]

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

Other 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. Links to other websites on rare diseases and related treatments are also provided.
Detailed information on this medicinal product is also available by scanning the QR code on the outer packaging with a smartphone. The same information can be accessed at the following address: www.imnovid-eu-pil.com.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION

Scientific conclusions
Taking into account the evaluation by the Pharmacovigilance Risk Assessment Committee (PRAC) of the final report of the post-authorisation non-interventional safety study (PASS) required for the above-mentioned medicinal product, the scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:
Study CC-4047-MM-015 was a condition for 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 educational package leaflet for healthcare professionals.
Therefore, in consideration of the available data from the final PASS study report, the PRAC concluded that changes to the terms 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.

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