Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
Braftovi 50 mg hard capsules.
Braftovi 75 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Braftovi 50 mg hard capsules: Orange opaque cap and flesh opaque body, printed with a stylised “A” on the cap and “LGX 50mg” on the body. The length of the capsule is approximately 22 mm. Braftovi 75 mg hard capsules: Flesh coloured opaque cap and white opaque body, printed with a stylised “A” on the cap and “LGX 75mg” on the body. The length of the capsule is approximately 23 mm. |
Braftovi 50 mg hard capsules: Each hard capsule contains 50 mg of encorafenib.
Braftovi 75 mg hard capsules: Each hard capsule contains 75 mg of encorafenib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Encorafenib |
Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor. Encorafenib suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K). Specifically, encorafenib inhibits in vitro and in vivo BRAFV600E,DandK mutant melanoma cell growth. |
| List of Excipients |
|---|
|
Capsule content: Copovidone (E1208) Capsule shell: Gelatin (E441) Printing ink: Shellac (E904) |
Braftovi 50 mg hard capsules:
Each pack contains either 28x1 or 112x1 hard capsules in polyamide/aluminium/PVC/aluminium/PET/paper perforated unit dose blisters.
Not all pack sizes may be marketed.
Braftovi 75 mg hard capsules:
Each pack contains either 42x1 or 168x1 hard capsules in polyamide/aluminium/PVC/aluminium/PET/paper perforated unit dose blisters.
Not all pack sizes may be marketed.
PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
Braftovi 50 mg hard capsules:
EU/1/18/1314/001 28x1 hard capsules
EU/1/18/1314/003 112x1 hard capsules
Braftovi 75 mg hard capsules:
EU/1/18/1314/002 42x1 hard capsules
EU/1/18/1314/004 168x1 hard capsules
Date of first authorisation: 20 September 2018
Date of latest renewal: 23 June 2023
| Drug | Countries | |
|---|---|---|
| BRAFTOVI | Austria, Australia, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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