Approval · Notice of Compliance 764 · 2001
AGENERASE: Notice of Compliance 764
Issued November 21, 2001
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
- 764
- Date
- November 21, 2001
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Change in manufacturer name
- Therapeutic class
- Antiretroviral agent
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- AMPRENAVIR 50 MG per CAP
- AMPRENAVIR 150 MG per CAP
- AMPRENAVIR 15 MG per ML