Regulatory Decision Summary for Xofluza
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this Supplemental New Drug Submission (SNDS) - Chemistry and Manufacturing/Labelling for Xofluza was to add a new tablet strength of 80 mg and to convert the Xofluza Product Monograph to 2020 format.
Why was the decision issued?
Based on the data submitted, Health Canada has authorized the 80 mg Xofluza tablet that is recommended for use in patients weighing at least 80 kg. The benefit-harm balance of Xofluza remains positive when used as described in the Xofluza Product Monograph at this time.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| XOFLUZA | 02524163 | HOFFMANN-LA ROCHE LIMITED | BALOXAVIR MARBOXIL 80 MG |