Approval · Notice of Compliance 9778 · 2008
TASIGNA: Notice of Compliance 9778
Issued September 9, 2008
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 9778
- Date
- September 9, 2008
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Protein-tyrosine kinase inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TASIGNA | 02315874 | Marketed |
Medicinal ingredients
- NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 MG per CAP