Approval · Notice of Compliance 18028 · 2016
ERIVEDGE: Notice of Compliance 18028
Issued April 6, 2016
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
- 18028
- Date
- April 6, 2016
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the product monograph with safety information from two clinical pharmacology studies; a hepatic/renal impariment study and a drug-drug interaction study
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ERIVEDGE | Not yet assigned | — |
Medicinal ingredients
- VISMODEGIB 150 MG per CAP