Regulatory Decision Summary for FIBRYGA (formerly FIBRYNA)
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:
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What was the purpose of this submission?
The intent of this NDS was to seek the market authorisation of Fibryga (formerly Fibryna) for the proposed indication: treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Why was the decision issued?
The submitted data suggest that Fibryga (formerly Fibryna) would be efficacious in the treatment of acute bleeding episodes and perioperative prophylaxis. This is based on the efficacy data for the treatment of bleeding episodes and during surgeries, as well as data of pharmacokinetics and maximum clot firmness. In addition, non-clinical and clinical data did not raise any special safety concerns for Fibryga (formerly Fibryna) , and the safety profile of Fibryga (formerly Fibryna) was acceptable. Therefore, the clinical benefits of Fibryga (formerly Fibryna) outweigh its risks for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibrinogenemia.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| FIBRYGA | 02464616 | OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H | FIBRINOGEN (HUMAN) 1 G / VIAL |