Approval · Notice of Compliance 18142 · 2016
TAFINLAR: Notice of Compliance 18142
Issued June 1, 2016
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 18142
- Date
- June 1, 2016
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfilment of the post-approval commitments for the notice of compliance with conditions for use in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma with a braf V600 mutation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TAFINLAR | Not yet assigned | — |
Medicinal ingredients
- DABRAFENIB 50 MG per CAP
- DABRAFENIB 75 MG per CAP