Approval · Notice of Compliance 19371 · 2017
COTELLIC: Notice of Compliance 19371
Issued June 1, 2017
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
- 19371
- Date
- June 1, 2017
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the product mongraph with follow-up efficacy and safety results from the pivotal and supportive studies
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| COTELLIC | Not yet assigned | — |
Medicinal ingredients
- COBIMETINIB FUMARATE 20 MG per TAB