Approval · Notice of Compliance 7654 · 2005
PEGASYS: Notice of Compliance 7654
Issued December 12, 2005
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
- 7654
- Date
- December 12, 2005
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication - treatment of chronic hepatitis c in hiv/hcv co-infection patients with stable hiv disease with or without antiretroviral therapy
- Therapeutic class
- Biological response modifier
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PEGASYS | Not yet assigned | — |
Medicinal ingredients
- PEGINTERFERON ALFA-2A 180 MCG per ML
- PEGINTERFERON ALFA-2A 180 MCG per 0.5ML