Regulatory Decision Summary for Prolastin-C
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 approval for the changes to the Prolastin-C Product Monograph as follows:
- Update the Indications to accurately reflect the disease genotypes of patients included in the clinical program previously reviewed and approved by Health Canada.
- Update the Product Monograph to reflect the treatment of patients with "emphysema"(rather than the more restrictive "panacinar emphysema"), consistent with the clinical program previously reviewed and approved by Health Canada.
Why was the decision issued?
Updating the existing Prolastin-C Product Monograph will ensure that it is consistent with both the recently approved labelling for Zemaira, as well as the clinical dataset most recently reviewed by Health Canada for this product.
The changes did not alter the risk-benefit profile for the use of Prolastin-C as indicated.
Decision issued
Approved; issued a Notice of Compliance