Approval · Notice of Compliance 12410 · 2011
REYATAZ: Notice of Compliance 12410
Issued May 5, 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
- 12410
- Date
- May 5, 2011
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of clinical trial data from HIV infected pregnant women. Updates to the Post-Market Data, and the Antiretroviral Pregnancy Registry
- Therapeutic class
- Azapeptide inhibitor of HIV-1 protease
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REYATAZ | Not yet assigned | — |
Medicinal ingredients
- ATAZANAVIR SULFATE 100 MG per CAP
- ATAZANAVIR SULFATE 150 MG per CAP
- ATAZANAVIR SULFATE 200 MG per CAP
- ATAZANAVIR SULFATE 300 MG per CAP