Approval · Notice of Compliance 26581 · 2021
XOFLUZA: Notice of Compliance 26581
Issued September 2, 2021
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
- 26581
- Date
- September 2, 2021
- 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 update the Product Monograph (PM) with regard to potential for drug interactions via UDPglucuronosyltransferase (UGT) enzymes and reduced susceptibility to baloxavir in influenza viruses bearing the PA/I38T/M/F/N/S mutations. To convert the PM to the 2020 Product Monograph format
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XOFLUZA | Not yet assigned | — |
Medicinal ingredients
- BALOXAVIR MARBOXIL 20 MG per TAB
- BALOXAVIR MARBOXIL 40 MG per TAB