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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 11 to 20

"TBSF" High Purity Factor VIII / Von Willebrand Factor Concentrate Cancelled under Section 30(1)(c) of the Act

12 October 2022

Cancellation by sponsor

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

30 August 2022

Designation or determination

Orphan drug
CSL New Zealand Rh(D) Immunoglobulin-VF (Human Anti-D Rho Immunoglobulin), 625 IU, solution for injection, vial Cancelled under Section 30(1)(c) of the Act

3 August 2022

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CSL New Zealand Biostate Human Coagulation Factor VIII, Freeze Dried 1000IU, powder for injection Cancelled under Section 30(1)(c) of the Act

17 June 2022

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CSL New Zealand Biostate Human Coagulation Factor VIII, Freeze Dried 500IU (100IU/mL), powder for injection Cancelled under Section 30(1)(c) of the Act

17 June 2022

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CSL New Zealand Biostate Human Coagulation Factor VIII, Freeze-Dried 500IU, powder for injection Cancelled under Section 30(1)(c) of the Act

17 June 2022

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CSL New Zealand Biostate Human Coagulation Factor VIII, Freeze-Dried 250IU, powder for injection Cancelled under Section 30(1)(c) of the Act

17 June 2022

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CSL Singapore 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

18 September 2021

Cancellation by sponsor

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

18 September 2021

Cancellation by sponsor

Requested by CSL Behring Australia Pty Ltd
CON-TGO91-220 - CSL Behring Australia Pty Ltd

24 August 2020

Section 14, TGO91 consent

Product(s) approved for Supply with noncompliant labelling.

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The Department of Health, Disability and Ageing acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.