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    (R)-Zanubrutinib

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    BeOne Medicines

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    Regulatory Info : DISCN

    Registration Country : USA

    ZANUBRUTINIB

    Brand Name : BRUKINSA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 80MG

    Packaging :

    Approval Date : 2019-11-14

    Application Number : 213217

    Regulatory Info : DISCN

    Registration Country : USA

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    Regulatory Info : RX

    Registration Country : USA

    ZANUBRUTINIB

    Brand Name : BRUKINSA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 160MG

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    Approval Date : 2025-06-10

    Application Number : 218785

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info :

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    ZANUBRUTINIB

    Brand Name : BRUKINSA

    Dosage Form : CAPSULE; ORAL

    Dosage Strength : 80MG

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Hard Capsule

    Dosage Strength : 80mg

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    Approval Date : 08/02/2022

    Application Number : 67998

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Regulatory Info : Marketed

    Registration Country : Norway

    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Capsule

    Dosage Strength : 80mg

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    Regulatory Info : Marketed

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    Regulatory Info : Prescription

    Registration Country : Estonia

    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Capsule

    Dosage Strength : 80mg

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    Regulatory Info : Prescription

    Registration Country : Estonia

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    Regulatory Info : Authorized

    Registration Country : Spain

    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Hard Capsule

    Dosage Strength : 80MG

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    Approval Date : 14-12-2021

    Application Number : 1211576001

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Authorized

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    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Film Coated Tablet

    Dosage Strength : 160MG

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    Approval Date : 03-10-2025

    Application Number : 1211576002

    Regulatory Info : Authorized

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    09

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    Regulatory Info : Authorized

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    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Hard Capsule

    Dosage Strength : 80MG

    Packaging :

    Approval Date : 03-09-2025

    Application Number : 1211576001IP

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Prescription

    Registration Country : Canada

    ZANUBRUTINIB

    Brand Name : BRUKINSA

    Dosage Form : CAPSULE

    Dosage Strength : 80MG

    Packaging :

    Approval Date :

    Application Number : 2512963

    Regulatory Info : Prescription

    Registration Country : Canada

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    11

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    Regulatory Info : Prescription

    Registration Country : Canada

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    Brand Name : BRUKINSA

    Dosage Form : TABLET

    Dosage Strength : 160MG

    Packaging :

    Approval Date :

    Application Number : 2554267

    Regulatory Info : Prescription

    Registration Country : Canada

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    Regulatory Info : Originator

    Registration Country : South Africa

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    Brand Name : BRUKINSA

    Dosage Form : CAP

    Dosage Strength : 80mg

    Packaging : 120X1mg

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    Regulatory Info : Originator

    Registration Country : South Africa

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    Regulatory Info :

    Registration Country : Australia

    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form :

    Dosage Strength :

    Packaging : 120

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    14

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    Registration Country : Australia

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    Packaging : 120

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    Regulatory Info :

    Registration Country : Australia

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    Packaging : 120

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    Registration Country : Australia

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Hard Capsules

    Dosage Strength : 80mg

    Packaging :

    Approval Date : 22-11-2021

    Application Number : 28106451520

    Regulatory Info : Prescription

    Registration Country : Denmark

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    Regulatory Info : Approved

    Registration Country : Sweden

    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Film Coated Tablet

    Dosage Strength : 160 mg

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    Approval Date : 14-08-2025

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    Regulatory Info : Approved

    Registration Country : Sweden

    Zanubrutinib

    Brand Name : Brukinsa

    Dosage Form : Capsule

    Dosage Strength : 80mg

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    Approval Date : 22-11-2021

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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