Approval · Notice of Compliance 15969 · 2014
ZELBORAF: Notice of Compliance 15969
Issued August 18, 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.
- Notice number
- 15969
- Date
- August 18, 2014
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of updated overall survival and sequencing results from the pivotal study no25026 to the product monograph
- Therapeutic class
- Protein kinase inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZELBORAF | Not yet assigned | — |
Medicinal ingredients
- VEMURAFENIB 240 MG per TAB