Approval · Notice of Compliance 24630 · 2020
VALCYTE: Notice of Compliance 24630
Issued November 18, 2020
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
- 24630
- Date
- November 18, 2020
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To change the graduation on the oral dispenser from milligrams to millilitres in the product monograph and oral solution package insert. revisions to the oral solution outer carton label were also requested and reviewed
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VALCYTE | Not yet assigned | — |
Medicinal ingredients
- VALGANCICLOVIR HYDROCHLORIDE 450 MG per TAB
- VALGANCICLOVIR HYDROCHLORIDE 50 MG per ML