Product information

From Health Canada

No match found

No other product was found with the same active ingredient group.

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:

Approved

Current status date:

2024-12-27

Product name:

BRUKINSA

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:

02554267

Product Monograph/Veterinary Labelling:

Date: 2024-12-27 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

BEIGENE SWITZERLAND GMBH
Aeschengraben 27, 21st Fl
Basel
--
Switzerland 4051

Class:

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01EL03 ZANUBRUTINIB

Active ingredient group (AIG) number:See footnote5

0162766002

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
ZANUBRUTINIB 160 MG

Risk Management Plans See footnote 7

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

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