Approval · Notice of Compliance 21497 · 2018
GILENYA: Notice of Compliance 21497
Issued November 7, 2018
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
- 21497
- Date
- November 7, 2018
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Extension of the indication to include ppediatric patients aged 10 to 18 years. addition of a new 0.25 mg capsule strength and formulation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GILENYA | Not yet assigned | — |
| GILENYA | 02482533 | Marketed |
Medicinal ingredients
- FINGOLIMOD HYDROCHLORIDE 0.5 MG per CAP
- FINGOLIMOD HYDROCHLORIDE 0.25 MG per CAP