Approval · Notice of Compliance 3539 · 2003
VALTREX: Notice of Compliance 3539
Issued May 6, 2003
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
- 3539
- Date
- May 6, 2003
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: provides for the treatment of cold sores (herpes labialis)
- Therapeutic class
- Antiviral agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VALTREX | Not yet assigned | — |
Medicinal ingredients
- VALACYCLOVIR HYDROCHLORIDE 500 MG per TAB
- VALACYCLOVIR HYDROCHLORIDE 1 G per TAB