Regulatory Decision Summary for RiaSTAP
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:
Summary of Cancellation: RiaSTAP
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
November 30, 2020
What was the purpose of this submission?
The purpose of this submission is to revise the current indication for RiaSTAP to include an additional product claim for treating patients with Acquired Hypofibrinogenemia as follows:
Proposed New Indication: As complementary therapy to the management of severe hemorrhage in acquired hypofibrinogenemia, for example:
- extensive blood loss and consumption of fibrinogen associated with life threatening bleeding in obstetric complications
- extensive blood loss and/or dilution coagulopathy and/or consumption of fibrinogen in cardiac surgery with cardiopulmonary bypass extensive blood loss and/or dilution coagulopathy in trauma.
What did the company submit to support its submission?
CSL Behring Canada Inc. provided clinical data, published studies and labelling documentation.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
The review was ongoing at the time of cancellation. Health Canadas assessment of the submission had identified some issues with the evidence that was available to support the revised indication. These issues were not resolved by the time the sponsor cancelled the submission.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
This decision is not expected to impact SAP or clinical trial access to this drug.