Regulatory Decision Summary for ProHance
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):
gadoteridol
Control Number:
253753
Therapeutic Area:
Paramagnetic contrast media
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 Supplemental New Drug Submission (SNDS) was filed to request authorization for the addition of a new 100 mL presentation for the drug product.
Why was the decision issued?
This Supplemental New Drug Submission (SNDS) was filed to request authorization for the addition of a new 100 mL presentation for the drug product. ProHance is currently authorized for single dose vials (10, 15, and 20 mL), pharmacy bulk package (50 mL), and single dose syringes (10 mL, 17 mL).
No significant Quality issues were noted with the additional presentation. No significant Label issues were noted with the submitted Product Monograph (PM), package insert, and inner and outer labels. Issues identified during the review were communicated to the Sponsor and were satisfactorily addressed.
The overall benefit-harm-uncertainty profile of ProHance remains favourable for the approved indications when used according to the approved label.
For further details about ProHance, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2022-01-28
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
02229056
Prescription status:
Available by prescription only
Date Filed:
2021-06-14
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| PROHANCE | 02229056 | BRACCO IMAGING CANADA | GADOTERIDOL 279.3 MG / ML |