Regulatory Decision Summary for Feiba NF
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 SNDS was to provide Health Canada with chemistry and manufacturing evidence to support an additional strength of 500U in 10 mL for Feiba NF. This SNDS submission was primarily based on quality data. A clinical waiver was granted as no new clinical data was required.
Why was the decision issued?
A clinical evaluation was conducted to ensure that the Product monograph (PM) submitted with this SNDS accurately reflects the changes previously approved under a Notifiable Change submission, and that this Product Monograph is acceptable from a clinical point of view.
It was noted that the references provided to support the changes previously submitted under the Notifiable Change were not included in the PM. It was therefore requested that these references be added to the PM. The resulting changes were considered acceptable and the additional dosage strength and Product Monograph were approved.
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 |
|---|---|---|---|
| FEIBA NF | 02489600 | TAKEDA CANADA INC | ANTI-INHIBITOR COAGULANT COMPLEX 650 UNIT / VIAL |