Approval · Notice of Compliance 12812 · 2011
TASIGNA: Notice of Compliance 12812
Issued November 30, 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.
- Notice number
- 12812
- Date
- November 30, 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
- Fullfilment of the final commitment as per the Letter of Undertaking dated July 10, 2008 for the treatment of accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or not toleant of at lease one prior therapy including imatinib; and other revisions to the product monograph
- Therapeutic class
- Protein-tyrosine Kinase Inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TASIGNA | Not yet assigned | — |
Medicinal ingredients
- NILOTINIB 200 MG per CAP