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01 1BEIGENE SOUTH AFRICA (PTY) LTD
02 12BeOne Medicines
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01 1CAP
02 1CAPSULE
03 1CAPSULE; ORAL
04 1CAPSULE;ORAL
05 1Capsule
06 2Hard Capsule
07 1TABLET
08 1TABLET;ORAL
09 4Blank
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01 1Allowed
02 1Approved
03 1Authorized
04 1DISCN
05 1Originator
06 2Prescription
07 1RX
08 5Blank
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01 6BRUKINSA
02 7Brukinsa
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01 4Australia
02 2Canada
03 1South Africa
04 1Spain
05 1Sweden
06 1Switzerland
07 3USA
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
Brand Name : BRUKINSA
Dosage Form : TABLET;ORAL
Dosage Strength : 160MG
Packaging :
Approval Date : 2025-06-10
Application Number : 218785
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : BRUKINSA
Dosage Form : CAPSULE; ORAL
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number : 218785
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Brukinsa
Dosage Form : Capsule
Dosage Strength : 80mg
Packaging :
Approval Date : 22/11/2021
Application Number : 20200527000024
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Brukinsa
Dosage Form : Hard Capsule
Dosage Strength : 80mg
Packaging :
Approval Date : 08/02/2022
Application Number : 67998
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BRUKINSA
Dosage Form : CAPSULE
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number : 2512963
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BRUKINSA
Dosage Form : TABLET
Dosage Strength : 160MG
Packaging :
Approval Date :
Application Number : 2554267
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Brukinsa
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brukinsa
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brukinsa
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Brukinsa
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Brukinsa
Dosage Form : Hard Capsule
Dosage Strength : 80MG
Packaging :
Approval Date : 2021-12-14
Application Number : 1211576001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : BRUKINSA
Dosage Form : CAP
Dosage Strength : 80mg
Packaging : 120X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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