Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Celgene Europe B.V., Winthontlaan 6 N, 3526 KV, Utrecht, Netherlands
Imnovid 1 mg hard capsules.
Imnovid 2 mg hard capsules.
Imnovid 3 mg hard capsules.
Imnovid 4 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 4 gelatin hard capsule. Imnovid 2 mg hard capsules: Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 2 gelatin hard capsule. Imnovid 3 mg hard capsules: Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 2 gelatin hard capsule. Imnovid 4 mg hard capsules: Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2 gelatin hard capsule. |
Imnovid 1 mg hard capsules: Each hard capsule contains 1 mg of pomalidomide.
Imnovid 2 mg hard capsules: Each hard capsule contains 2 mg of pomalidomide.
Imnovid 3 mg hard capsules: Each hard capsule contains 3 mg of pomalidomide.
Imnovid 4 mg hard capsules: Each hard capsule contains 4 mg of pomalidomide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pomalidomide |
Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma tumour cell growth. Pomalidomide in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma. |
| List of Excipients |
|---|
|
Capsule contents: Mannitol (E421) Capsule shell: Imnovid 1 mg hard capsules: Gelatin Imnovid 2 mg hard capsules: Gelatin Imnovid 3 mg hard capsules: Gelatin Imnovid 4 mg hard capsules: Gelatin Printing ink: Imnovid 1 mg hard capsules: White ink: Shellac, Titanium dioxide (E171), Simeticone, Propylene glycol (E1520), Ammonium hydroxide (E527) Black ink: Shellac, Iron oxide black (E172), Propylene glycol (E1520), Ammonium hydroxide (E527) Imnovid 2 mg hard capsules, Imnovid 3 mg hard capsules, Imnovid 4 mg hard capsules: White ink: Shellac, Titanium dioxide (E171), Simeticone, Propylene glycol (E1520), Ammonium hydroxide (E527) |
The capsules are packaged in Polyvinyl chloride (PVC)/ polychlorotrifluoroethylene (PCTFE) blisters with push through aluminium foil.
Pack size of 14 or 21 capsules.
Not all pack size may be marketed.
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV, Utrecht, Netherlands
Imnovid 1 mg hard capsules:
EU/1/13/850/001
EU/1/13/850/005
Imnovid 2 mg hard capsules:
EU/1/13/850/002
EU/1/13/850/006
Imnovid 3 mg hard capsules:
EU/1/13/850/003
EU/1/13/850/007
Imnovid 4 mg hard capsules:
EU/1/13/850/004
EU/1/13/850/008
Date of first authorisation: 05 August 2013
Date of latest renewal: 11 July 2018
| Drug | Countries | |
|---|---|---|
| IMNOVID | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom |
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