Approval · Notice of Compliance 17305 · 2015
TASIGNA: Notice of Compliance 17305
Issued August 19, 2015
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
- 17305
- Date
- August 19, 2015
- 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 final post-approval commitment for the notice of compliance with conditions market authorization of tasigna for use in patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (ph+cma) in chronic phase
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TASIGNA | Not yet assigned | — |
Medicinal ingredients
- NILOTINIB HYDROCHLORIDE MONOHYDRATE 150 MG per CAP
- NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 MG per CAP