Approval · Notice of Compliance 3416 · 2003
TAMIFLU: Notice of Compliance 3416
Issued December 23, 2003
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
- 3416
- Date
- December 23, 2003
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: provides for prevention of influenza in adult and adolescents 13 years and older
- Therapeutic class
- Antiviral agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TAMIFLU | Not yet assigned | — |
Medicinal ingredients
- OSELTAMIVIR PHOSPHATE 75 MG per CAP
- OSELTAMIVIR PHOSPHATE 12 MG per ML