Approval · Notice of Compliance 12919 · 2011
PREZISTA: Notice of Compliance 12919
Issued October 4, 2011
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
- 12919
- Date
- October 4, 2011
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product monograph: Addition of 192 week safety and efficacy data for treatment-naïve patients; label changes made to the Comapany Core Data Sheet of December 2010
- Therapeutic class
- Human Immunodeficiency Virus (HIV) Protease Inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREZISTA | Not yet assigned | — |
Medicinal ingredients
- DARUNAVIR ETHANOLATE 75 MG per TAB
- DARUNAVIR ETHANOLATE 300 MG per TAB
- DARUNAVIR ETHANOLATE 400 MG per TAB
- DARUNAVIR ETHANOLATE 600 MG per TAB
- DARUNAVIR ETHANOLATE 150 MG per TAB