Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pierre Fabre Mรฉdicament, 45, place Abel Gance, 92100, Boulogne-Billancourt, France
Braftovi 50 mg hard capsules.
Braftovi 75 mg hard capsules.
Pharmaceutical Form |
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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 | |
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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 |
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Capsule content: Copovidone (E1208) Capsule shell: Gelatin (E441) Printing ink: Shellac (E904) |
Braftovi 50 mg hard capsules:
Polyamide/aluminum/PVC/aluminum blister containing 4 capsules.
Each pack contains either 28 or 112 hard capsules.
Not all pack sizes may be marketed.
Braftovi 75 mg hard capsules:
Polyamide/aluminum/PVC/aluminum blister containing 6 capsules.
Each pack contains either 42 or 168 hard capsules.
Not all pack sizes may be marketed.
Pierre Fabre Mรฉdicament, 45, place Abel Gance, 92100, Boulogne-Billancourt, France
Braftovi 50 mg hard capsules:
EU/1/18/1314/001 28 hard capsules
EU/1/18/1314/003 112 hard capsules
Braftovi 75 mg hard capsules:
EU/1/18/1314/002 42 hard capsules
EU/1/18/1314/004 168 hard capsules
Date of first authorisation: 20 September 2018
Drug | Countries | |
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BRAFTOVI | Austria, Australia, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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