Approval · Notice of Compliance 10558 · 2009
PHL-VALACYCLOVIR: Notice of Compliance 10558
Issued August 31, 2009
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
- 10558
- Date
- August 31, 2009
- Company
- Pharmel Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Antiviral agent
- Canadian reference product
- VALTREX (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PHL-VALACYCLOVIR | 02307944 | Cancelled Post Market |
Medicinal ingredients
- VALACYCLOVIR HYDROCHLORIDE 500 MG per TAB