Approval · Notice of Compliance 9630 · 2008
PREZISTA: Notice of Compliance 9630
Issued June 18, 2008
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 9630
- Date
- June 18, 2008
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the product monograph
- Therapeutic class
- Human immunodeficiency virus (HIV) protease inhibitor
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREZISTA | Not yet assigned | — |
Medicinal ingredients
- DARUNAVIR ETHANOLATE 300 MG per TAB