BRAFTOVI Hard capsule Ref.[8687] Active ingredients: Encorafenib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Pierre Fabre Mรฉdicament, 45, place Abel Gance, 92100, Boulogne-Billancourt, France

Product name and form

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.

Qualitative and quantitative composition

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)
Poloxamer 188
Cellulose microcrystalline (E460i)
Succinic acid (E363)
Crospovidone (E1202)
Silica colloidal anhydrous (E551)
Magnesium stearate (E470b)

Capsule shell:

Gelatin (E441)
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide yellow (E172)
Iron oxide black (E172)

Printing ink:

Shellac (E904)
Iron oxide black (E172)
Propylene glycol (E1520)

Pack sizes and marketing

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.

Marketing authorization holder

Pierre Fabre Mรฉdicament, 45, place Abel Gance, 92100, Boulogne-Billancourt, France

Marketing authorization dates and numbers

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

Drugs

Drug Countries
BRAFTOVI Austria, Australia, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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