Approval · Notice of Compliance 15861 · 2014
TASIGNA: Notice of Compliance 15861
Issued July 22, 2014
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
- 15861
- Date
- July 22, 2014
- 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
- Update to the product monograph with efficacy and safety information pertaining to the indication: 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 | Not yet assigned | — |