Approval · Notice of Compliance 30979 · 2023
APO-VALACYCLOVIR: Notice of Compliance 30979
Issued June 13, 2023
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
- 30979
- Date
- June 13, 2023
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to the product monograph. Update to the package insert. Update to labels
- Canadian reference product
- VALTREX (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-VALACYCLOVIR | Not yet assigned | — |
Medicinal ingredients
- VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE 500 MG per TAB
- VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE 1,000 MG per TAB