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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:

2019-03-18

Original market date: See footnote 1

2019-03-18

Product name:

BRINEURA

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:

02484013

Product Monograph/Veterinary Labelling:

Date: 2020-06-01 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

BIOMARIN INTERNATIONAL LIMITED
Shanbally
Ringaskiddy
Cork
Ireland  P43R298

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intracerebroventricular

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

44:00.00   ENZYMES

Anatomical Therapeutic Chemical (ATC): See footnote 4

A16AB17  CERLIPONASE ALFA

Active ingredient group (AIG) number:See footnote 5

0161050001

List of active ingredient(s)
Active ingredient(s) Strength
CERLIPONASE ALFA 150 MG / 5 ML

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