Approval · Notice of Compliance 11083 · 2010
PEGETRON: Notice of Compliance 11083
Issued February 23, 2010
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
- 11083
- Date
- February 23, 2010
- 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
- New dosing and extension of indication: Treatment of adult patients (18 years of age and older) with chronic hepatitis C who have compensated liver disease and are positive for HCV-RNA, including patients who have not received previous treatment or who failed prior treatment with Interferon Alpha (pegylated or non-pegylated) and Ribavirin combination therapy
- 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
- RIBAVIRIN 200 MG per CAP
- PEGINTERFERON ALFA-2B 50 MCG per 0.5ML
- 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