Regulatory Decision Summary for Hizentra
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?
This submission proposed the introduction of one new presentation for Hizentra of 20 mL pre-filled polymer syringes, as an additional filling size to already approved 5 mL and 10 mL pre-filled syringes. This offers health care providers and patients additional dosing convenience.
Why was the decision issued?
This new dosage form did not require any new clinical trials or data to be provided. The review focused on ensuring that the product in the new dosage form was equivalent in quality to the other dosage forms.
In their rationale, the sponsor indicated the following:
- The final formulation of the drug product has not changed;
- The chemical, biological and immunological requirements for batch release has not changed;
- The route of administration, subcutaneous, has not changed;
- A comparability assessment demonstrated that product manufactured after implementation of the change was the same as the product manufactured before the change.
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 |
|---|---|---|---|
| HIZENTRA | 02498251 | CSL BEHRING CANADA INC | IMMUNOGLOBULIN (HUMAN) 200 MG / ML |