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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:

2016-02-19

Original market date: See footnote 1

2016-02-19

Product name:

BRIDION

Description:

2ML & 5ML SINGLE USE VIALS

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:

02451816

Product Monograph/Veterinary Labelling:

Date: 2021-02-22 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

MERCK CANADA INC
16750 Route Transcanadienne
Kirkland
Quebec
Canada  H9H 4M7

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

92:12.00   ANTIDOTES

Anatomical Therapeutic Chemical (ATC): See footnote 4

V03AB35  SUGAMMADEX

Active ingredient group (AIG) number:See footnote 5

0157810001

List of active ingredient(s)
Active ingredient(s) Strength
SUGAMMADEX (SUGAMMADEX SODIUM) 100 MG / ML

Risk Management Plans See footnote 7

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

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