Approval · Notice of Compliance 24802 · 2020
GILENYA: Notice of Compliance 24802
Issued December 15, 2020
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
- 24802
- Date
- December 15, 2020
- 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
- Revise warnings and precautions and adverse reactions sections of the product monograph along with other minor editorial revisions
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GILENYA | Not yet assigned | — |
Medicinal ingredients
- FINGOLIMOD HYDROCHLORIDE 0.25 MG per CAP
- FINGOLIMOD HYDROCHLORIDE 0.5 MG per CAP