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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:

2021-03-30

Original market date: See footnote 1

2021-03-30

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:

02512963

Product Monograph/Veterinary Labelling:

Date: 2021-02-26 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

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

Class: 

Human

Dosage form(s):

Capsule

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00   ANTINEOPLASTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

 

Active ingredient group (AIG) number:See footnote 5

0162766001

List of active ingredient(s)
Active ingredient(s) Strength
ZANUBRUTINIB 80 MG

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