Regulatory Decision Summary for Rebinyn
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:
Contact:
Medicinal Ingredient(s):
Coagulation factor IX (recombinant), pegylated
Control Number:
263051
Brand/Product Name:
Rebinyn
Therapeutic Area:
B02
Type of Submission:
Supplement to a New Drug Submission
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) was filed for Rebinyn (Coagulation Factor IX [Recombinant], Pegylated) for a new 3,000 IU/vial strength, an alternate lyophilizer, and new increased formulation protein target. Upon review of the submitted data package, Health Canada authorized Rebinyn as filed.
Why was the decision issued?
The Quality information submitted for Rebinyn has demonstrated that the new 3,000 IU/vial strength can be consistently manufactured to meet the approved specifications.
Overall, the benefit-harm-uncertainty profile was favourable for Rebinyn for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.
For further details about Rebinyn, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2022-11-22
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
02532964
Prescription Status:
Schedule D drug
Date Filed:
2022-04-06
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| REBINYN | 02532964 | NOVO NORDISK CANADA INC | COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 3000 UNIT / VIAL |