Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Revlimid 2.5 mg hard capsules.
Revlimid 5 mg hard capsules.
Revlimid 7.5 mg hard capsules.
Revlimid 10 mg hard capsules.
Revlimid 15 mg hard capsules.
Revlimid 20 mg hard capsules.
Revlimid 25 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Revlimid 2.5 mg hard capsules: Blue-green/white capsules, size 4, 14.3 mm, marked “REV 2.5 mg”. Revlimid 5 mg hard capsules: White capsules, size 2, 18.0 mm, marked “REV 5 mg”. Revlimid 7.5 mg hard capsules: Pale yellow/white capsules, size 2, 18.0 mm, marked “REV 7.5 mg”. Revlimid 10 mg hard capsules: Blue-green/pale yellow capsules, size 0, 21.7 mm, marked “REV 10 mg”. Revlimid 15 mg hard capsules: Pale blue/white capsules, size 0, 21.7 mm, marked “REV 15 mg”. Revlimid 20 mg hard capsules: Blue-green/pale blue capsules, size 0, 21.7 mm, marked “REV 20 mg”. Revlimid 25 mg hard capsules: White capsules, size 0, 21.7 mm, marked “REV 25 mg”. |
Each capsule contains 2.5 mg of lenalidomide.
Excipient(s) with known effect: Each capsule contains 73.5 mg of lactose (as anhydrous lactose).
Each capsule contains 5 mg of lenalidomide.
Excipient(s) with known effect: Each capsule contains 147 mg of lactose (as anhydrous lactose).
Each capsule contains 7.5 mg of lenalidomide.
Excipient(s) with known effect: Each capsule contains 144.5 mg of lactose (as anhydrous lactose).
Each capsule contains 10 mg of lenalidomide.
Excipient(s) with known effect: Each capsule contains 294 mg of lactose (as anhydrous lactose).
Each capsule contains 15 mg of lenalidomide.
Excipient(s) with known effect: Each capsule contains 289 mg of lactose (as anhydrous lactose).
Each capsule contains 20 mg of lenalidomide.
Excipient(s) with known effect: Each capsule contains 244.5 mg of lactose (as anhydrous lactose).
Each capsule contains 25 mg of lenalidomide.
Excipient(s) with known effect: Each capsule contains 200 mg of lactose (as anhydrous lactose).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lenalidomide |
Lenalidomide binds directly to cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4 (CUL4), and regulator of cullins 1 (Roc1). Specifically, lenalidomide inhibits proliferation and enhances apoptosis of certain haematopoietic tumour cells (including MM plasma tumour cells, follicular lymphoma tumour cells and those with deletions of chromosome 5), enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases the number of NK, T and NK T cells. The lenalidomide mechanism of action also includes additional activities such as anti-angiogenic and proerythropoietic properties. |
| List of Excipients |
|---|
|
Capsule contents: Anhydrous lactose Capsule shell: Revlimid 2.5 mg/ 10 mg/ 20 mg hard capsules: Gelatin Revlimid 5 mg/ 25 mg hard capsules: Gelatin Revlimid 15 mg hard capsules: Gelatin Printing ink: Shellac |
Polyvinylchloride (PVC) / Polychlorotrifluoroethylene (PCTFE) / Aluminium foil blisters containing 7 hard capsules.
Revlimid 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg hard capsules: Pack size of 7 or 21 capsules. Not all pack sizes may be available.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Revlimid 2.5 mg hard capsules:
EU/1/07/391/005
EU/1/07/391/007
Revlimid 5 mg hard capsules:
EU/1/07/391/001
EU/1/07/391/008
Revlimid 7.5 mg hard capsules:
EU/1/07/391/006
EU/1/07/391/012
Revlimid 10 mg hard capsules:
EU/1/07/391/002
EU/1/07/391/010
Revlimid 15 mg hard capsules:
EU/1/07/391/003
EU/1/07/391/011
Revlimid 20 mg hard capsules:
EU/1/07/391/009
EU/1/07/391/013
Revlimid 25 mg hard capsules:
EU/1/07/391/004
EU/1/07/391/014
Date of first authorisation: 14 June 2007
Date of latest renewal: 16 February 2017
| Drug | Countries | |
|---|---|---|
| REVLIMID | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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