Approval · Notice of Compliance 15977 · 2014
PEGASYS RBV: Notice of Compliance 15977
Issued August 15, 2014
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
- 15977
- Date
- August 15, 2014
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Additional manufacturing facility
- Therapeutic class
- Biological response modifier plus antiviral agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PEGASYS RBV | Not yet assigned | — |
Medicinal ingredients
- RIBAVIRIN 200 MG per ML
- PEGINTERFERON ALFA-2A 180 MCG per ML
- PEGINTERFERON ALFA-2A 180 MCG per 0.5ML