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:
2019-03-18
Original market date: See footnote 1
2019-03-18
Product name:
BRINEURA
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
American Hospital Formulary Service (AHFS): See footnote 3
44:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
A16AB17 CERLIPONASE ALFA
Active ingredient group (AIG) number:See footnote5
0161050001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| CERLIPONASE ALFA | 150 MG / 5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |