Regulatory Decision Summary for Nuwiq
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):
Simoctocog alfa
Control Number:
264181
Brand/Product Name:
Nuwiq
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 Nuwiq (Antihemophilic Factor [Recombinant, B-Domain deleted]) for a new 1,500 IU/vial Drug Product strength. Upon review of the submitted data package, Health Canada authorized Nuwiq as filed.
Why was the decision issued?
The Quality information submitted for Nuwiq has demonstrated that the new 1,500 IU/vial strength can be consistently manufactured to meet the approved specification using an approved filling/finish process.
Overall, the benefit-harm-uncertainty profile was favourable for Nuwiq (1,500 IU/vial) for the approved indications 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 Nuwiq, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2022-12-29
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
02534169
Prescription Status:
Schedule D drug
Date Filed:
2022-05-12
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| NUWIQ | 02534169 | OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H | SIMOCTOCOG ALFA 1500 UNIT / VIAL WATER 2.5 ML / SYR |