Approval · Notice of Compliance 13563 · 2012
TASIGNA: Notice of Compliance 13563
Issued August 17, 2012
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
- 13563
- Date
- August 17, 2012
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Fulfillment of Post Approval Comitment #1 in accordance with the Letter of Undertaking dated May 10, 2011
- Therapeutic class
- Protein-Tyrosine Kinase Inhibitor
- With conditions
- Yes (NOC/c)
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