Approval · Notice of Compliance 9190 · 2007
TELZIR: Notice of Compliance 9190
Issued November 23, 2007
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
- 9190
- Date
- November 23, 2007
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expanded indication to include pediatric patients 6 years of age and older
- Therapeutic class
- Antiretroviral agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TELZIR | Not yet assigned | — |
Medicinal ingredients
- FOSAMPRENAVIR CALCIUM 700 MG per TAB
- FOSAMPRENAVIR CALCIUM 50 MG per ML