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BRUKINSA 80 mg hard capsules

*
Pharmacy Only: Prescription

  • Company:

    BeiGene

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Zanubrutinib

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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Updated on 25 April 2025

File name

20250411_IE_ BRUKINSA_SPC_BR_040 clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

7 MARKETING AUTHORISATION HOLDER

Beigene Ireland Limited BeOne Medicines Ireland Limited.

Updated on 25 April 2025

File name

20250411_IE_ BRUKINSA_PIL BR_040 clean.pdf

Reasons for updating

  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 6

Marketing Authorisation Holder 

Beigene Ireland Limited to BeOne Medicines Ireland Limited

Updated on 30 April 2024

File name

20231115_NI & IE_ BRUKINSA_PIL BR_005 clean.pdf

Reasons for updating

  • Changes to therapeutic indications

Updated on 30 April 2024

File name

20231115_NI & IE_ BRUKINSA_SPC BR_005.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 June 2023

File name

20230204_NI & IE_SmPC_ BRUKINSA_SPC BR_006 Clean.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 June 2023

File name

20230204_NI & IE_SmPC_ BRUKINSA_SPC BR_006 Clean.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 June 2023

File name

20230204_NI & IE_Brukinsa_PIL_BR_006 clean.pdf

Reasons for updating

  • New PIL for new product

BeiGene

BeiGene