Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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”. |
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 Capsule shell: Red iron oxide (E172) Printing ink: Black iron oxide (E172) |
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.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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
| Drug | Countries | |
|---|---|---|
| TAFINLAR | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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