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CSL Behring Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

Cancellation by sponsor (77)
Prescription medicine registration (4)
Designation or determination (3)
Australian public assessment report (AusPar) (1)
Section 14, TGO91 consent (1)

Date

2025 (1)
2024 (2)
2023 (4)
2022 (10)
2021 (2)
2020 (3)
2019 (9)
2018 (4)
2017 (3)
2016 (2)
2015 (46)

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Sponsor content

86 result(s) found, displaying 1 to 10

ANDEMBRY (CSL Behring Australia Pty Ltd)

9 January 2025

Prescription medicine registration

Active ingredients: garadacimab.
CSL Hong Kong Aleviate Human Coagulation Factor VIII 500IU/von Willebrand factor 1000IU complex, Powder for injection (50 IU/mL FVIII) Cancelled under Section 30(1)(c) of the Act

23 April 2024

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
HEMGENIX (CSL Behring Australia Pty Ltd)

15 March 2024

Prescription medicine registration

Active ingredients: etranacogene dezaparvovec.
Notice for garadacimab (CSL Behring Australia Pty Ltd)

25 September 2023

Designation or determination

Orphan drug
CSL Malaysia Aleviate Human Coagulation Factor VIII 500IU/von Willebrand factor 1200IU complex, Powder for injection (50 IU/mL FVIII) Cancelled under Section 30(1)(c) of the Act

16 May 2023

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CSL Malaysia Aleviate Human Coagulation Factor VIII 250IU/von Willebrand factor 600IU complex, Powder for injection (50 IU/mL FVIII) Cancelled under Section 30(1)(c) of the Act

16 May 2023

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CSL Hong Kong Biostate Human Coagulation Factor VIII 250IU/von Willebrand factor 500IU complex, Powder for injection (50 IU/mL FVIII) Cancelled under Section 30(1)(c) of the Act

16 May 2023

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
Notice for etranacogene dezaparvovec (CSL Behring Australia Pty Ltd)

20 December 2022

Designation or determination

Provisional determination
CSL Malaysia Biostate® Human Coagulation Factor VIII 500 IU/von Willebrand Factor 1000 IU powder for injection vial Cancelled under Section 30(1)(c) of the Act

12 October 2022

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CSL Malaysia Biostate® Human Coagulation Factor VIII 250 IU/von Willebrand Factor 500 IU powder for injection vial Cancelled under Section 30(1)(c) of the Act

12 October 2022

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd

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