Regulatory Decision Summary for Zemaira
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?
Zemaira is a human plasma-derived alpha-1 antitrypsin proteinase inhibitor (A1-PI), indicated for maintenance treatment in adults with severe A1-PI deficiency and clinical evidence of emphysema.
The purpose of this Supplemental New Drug Submission (SNDS) is to add 2 additional drug product presentations of 4g/vial and 5g/vial and 2 new diluent fill sizes of 76mL and 95mL.
Why was the decision issued?
Currently, Zemaira is approved in Canada in a 1g fill size with a 20 mL sterile water for injection diluent. This submission adds new 4 and 5g formats with accompanying diluent (76 and 95mL) to simplify patient dosing (fewer vials required). The review of manufacturing processes and supportive data for the new formats and diluent was satisfactory and the product monograph updated accordingly.
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 |
|---|---|---|---|
| ZEMAIRA | 02494779 | CSL BEHRING CANADA INC | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 5000 MG / VIAL |
| ZEMAIRA | 02494760 | CSL BEHRING CANADA INC | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 4000 MG / VIAL |