Approval · Notice of Compliance 10761 · 2009
PEGETRON: Notice of Compliance 10761
Issued November 6, 2009
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
- 10761
- Date
- November 6, 2009
- Company
- Schering-Plough Canada Inc.Pointe-Claire, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new clinical data to the Pegetron Product Monograph
- Therapeutic class
- Antiviral agent plus biological response modifier
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PEGETRON | Not yet assigned | — |
| PEGETRON REDIPEN | Not yet assigned | — |
Medicinal ingredients
- PEGINTERFERON ALFA-2B 50 MCG per 0.5ML
- RIBAVIRIN 200 MG per CAP
- PEGINTERFERON ALFA-2B 80 MCG per 0.5ML
- PEGINTERFERON ALFA-2B 100 MCG per 0.5ML
- PEGINTERFERON ALFA-2B 120 MCG per 0.5ML
- PEGINTERFERON ALFA-2B 150 MCG per 0.5ML