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01 4BEONE MEDICINES AUS PTY LTD

02 15BeOne Medicines

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PharmaCompass

01

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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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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02

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

ZANUBRUTINIB

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

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03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

ZANUBRUTINIB

Brand Name : BRUKINSA

Dosage Form : CAPSULE; ORAL

Dosage Strength : 80MG

Packaging :

Approval Date :

Application Number : 218785

Regulatory Info :

Registration Country : USA

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04

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Zanubrutinib

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

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05

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form : Capsule

Dosage Strength : 80mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form : Capsule

Dosage Strength : 80mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form : Hard Capsule

Dosage Strength : 80MG

Packaging :

Approval Date : 14-12-2021

Application Number : 1211576001

Regulatory Info : Authorized

Registration Country : Spain

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08

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form : Film Coated Tablet

Dosage Strength : 160MG

Packaging :

Approval Date : 03-10-2025

Application Number : 1211576002

Regulatory Info : Authorized

Registration Country : Spain

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09

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

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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10

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

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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11

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form : Film Coated Tablet

Dosage Strength : 160 mg

Packaging :

Approval Date : 14-08-2025

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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12

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form : Capsule

Dosage Strength : 80mg

Packaging :

Approval Date : 22-11-2021

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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13

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

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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14

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

ZANUBRUTINIB

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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15

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

ZANUBRUTINIB

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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16

BEONE MEDICINES AUS PTY LTD

Country
PEGS Boston Summit
Not Confirmed
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BEONE MEDICINES AUS PTY LTD

Country
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PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

BEONE MEDICINES AUS PTY LTD

Country
PEGS Boston Summit
Not Confirmed
arrow

BEONE MEDICINES AUS PTY LTD

Country
arrow
PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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18

BEONE MEDICINES AUS PTY LTD

Country
PEGS Boston Summit
Not Confirmed
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BEONE MEDICINES AUS PTY LTD

Country
arrow
PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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19

BEONE MEDICINES AUS PTY LTD

Country
PEGS Boston Summit
Not Confirmed
arrow

BEONE MEDICINES AUS PTY LTD

Country
arrow
PEGS Boston Summit
Not Confirmed

Zanubrutinib

Brand Name : Brukinsa

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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