Approval · Notice of Compliance 8633 · 2007
HEPSERA: Notice of Compliance 8633
Issued March 5, 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
- 8633
- Date
- March 5, 2007
- Company
- Gilead Sciences, Inc.Foster City, California, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the product monograph with long term data from study gs-98-435 regarding an assessment of the safety and efficacy of hepsera in hepatitis b patients both pre- and post-liver transplantation
- Therapeutic class
- Antiviral agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HEPSERA | Not yet assigned | — |
Medicinal ingredients
- ADEFOVIR DIPIVOXIL 10 MG per TAB