TANIFLAR Hard capsule Ref.[8932] Active ingredients: Dabrafenib

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Tafinlar 50 mg hard capsules.
Tafinlar 75 mg hard capsules.

Pharmaceutical Form

Hard capsule (capsule).

Tafinlar 50 mg hard capsules: Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with “GS TEW” and “50 mg”.

Tafinlar 75 mg hard capsules: Opaque dark pink capsules, approximately 19 mm long, with capsule shell imprinted with “GS LHF” and “75 mg”.

Qualitative and quantitative composition

Tafinlar 50 mg hard capsules: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of dabrafenib.

Tafinlar 75 mg hard capsules: Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of dabrafenib.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dabrafenib

Dabrafenib is an inhibitor of RAF kinases. Oncogenic mutations in BRAF lead to constitutive activation of the RAS/RAF/MEK/ERK pathway. BRAF mutations have been identified at a high frequency in specific cancers, including approximately 50% of melanoma. Dabrafenib demonstrated suppression of a downstream pharmacodynamic biomarker (phosphorylated ERK) and inhibited cell growth of BRAF V600 mutant melanoma cell lines, in vitro and in animal models.

List of Excipients

Capsule content:

Microcrystalline cellulose
Magnesium stearate
Colloidal silicone dioxide

Capsule shell:

Red iron oxide (E172)
Titanium dioxide (E171)
Hypromellose (E464)

Printing ink:

Black iron oxide (E172)
Shellac
Propylene glycol

Pack sizes and marketing

Opaque white high density polyethylene (HDPE) bottle with polypropylene screw cap and a silica gel desiccant.

Each bottle contains either 28 or 120 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

Tafinlar 50 mg hard capsules:

EU/1/13/865/001
EU/1/13/865/002

Tafinlar 75 mg hard capsules:

EU/1/13/865/003
EU/1/13/865/004

Date of first authorisation: 26 August 2013
Date of latest renewal: 08 May 2018

Drugs

Drug Countries
TAFINLAR Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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