Approval · Notice of Compliance 11399 · 2010
VALCYTE: Notice of Compliance 11399
Issued May 19, 2010
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
- 11399
- Date
- May 19, 2010
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of treatment duration for the prevention of CMV disease and addition of Pediatric, Pharmacokinetic data
- Therapeutic class
- Antiviral agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VALCYTE | Not yet assigned | — |
Medicinal ingredients
- VALGANCICLOVIR HYDROCHLORIDE 50 MG per ML
- VALGANCICLOVIR HYDROCHLORIDE 450 MG per TAB