Approval · Notice of Compliance 12453 · 2011
TASIGNA: Notice of Compliance 12453
Issued June 22, 2011
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
- 12453
- Date
- June 22, 2011
- 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
- New strength: 150mg capsule New indication: For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (PH+CML) in chronic phase
- Therapeutic class
- Protein-tyrosine kinase inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TASIGNA | 02368250 | Marketed |
| TASIGNA | Not yet assigned | — |
Medicinal ingredients
- NILOTINIB HYDROCHLORIDE MONOHYDRATE 150 MG per CAP
- NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 MG per CAP