Product information

From Health Canada

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

1998-09-08

Original market date: See footnote 1

1998-09-08

Product name:

PROHANCE

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02229056

Product Monograph/Veterinary Labelling:

Date: 2024-03-15 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

BRACCO IMAGING CANADA
11065 Boul. L-H Lafontaine
Ville D'Anjou
Quebec
Canada H1J 2Z4

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Ethical

 

American Hospital Formulary Service (AHFS): See footnote 3

36:89.00* See footnote6 

Anatomical Therapeutic Chemical (ATC): See footnote 4

V08CA04 GADOTERIDOL

Active ingredient group (AIG) number:See footnote5

0124199001

List of active ingredient(s)
Active ingredient(s) Strength
GADOTERIDOL 279.3 MG / ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Additional Risk Minimization Measures
Healthcare Professional Checklist
Pharmacovigilance/Monitoring Activity
Observational Studies
Drug Utilisation Study (DUS)
Version 4.0.2
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