Regulatory Decision Summary for Skyrizi
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 submission is to seek market authorization for Skyrizi (risankizumab) for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Why was the decision issued?
Based on the evaluation of the data submitted, and as labelled, BGTD considers that this NDS, control #215753, for the use of Skyrizi (risankizumab) in the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, complies with the Food and Drug Regulations. A Notice of Compliance (NOC) is recommended.
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 |
|---|---|---|---|
| SKYRIZI | 02487454 | ABBVIE CORPORATION | RISANKIZUMAB 75 MG / 0.83 ML |