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Celltrion Healthcare Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (27)
Cancellation by sponsor (12)
Australian Public Assessment Report (AusPAR) (4)
Prescription medicine registration (4)
Designation or determination (1)
Prescription medicine decision summary (1)

Date

2024 (6)
2023 (18)
2022 (6)
2021 (4)
2020 (5)
2019 (1)
2018 (3)
2015 (1)
2012 (1)
2001 (3)
1992 (1)

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49 result(s) found, displaying 11 to 20

YUFLYMA adalimumab 80 mg/0.8 mL solution for injection pre-filled syringe (396990)

30 June 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for YUFLYMA adalimumab 80 mg/0.8 mL solution for injection pre-filled syringe.
VEGZELMA (Celltrion Healthcare Australia Pty Ltd)

30 August 2023

Prescription medicine registration

Active ingredients: Bevacizumab.
EMISIMA infliximab (rmc) 100mg Powder for Injection vial Cancelled under Section 30(1)(c) of the Act

1 August 2023

Cancellation by sponsor

Requested by Celltrion Healthcare Australia Pty Ltd
FLIXCELI infliximab (rmc) 100mg Powder for Injection vial Cancelled under Section 30(1)(c) of the Act

1 August 2023

Cancellation by sponsor

Requested by Celltrion Healthcare Australia Pty Ltd
RITUZENA rituximab (rch) 500 mg/ 50 mL concentrate solution for intravenous infusion Cancelled under Section 30(1)(c) of the Act

23 June 2023

Cancellation by sponsor

Requested by Celltrion Healthcare Australia Pty Ltd
TUXELLA rituximab (rch) 500 mg/ 50 mL concentrate solution for intravenous infusion Cancelled under Section 30(1)(c) of the Act

23 June 2023

Cancellation by sponsor

Requested by Celltrion Healthcare Australia Pty Ltd
TUXELLA rituximab (rch) 100 mg/ 10 mL concentrate solution for intravenous infusion Cancelled under Section 30(1)(c) of the Act

23 June 2023

Cancellation by sponsor

Requested by Celltrion Healthcare Australia Pty Ltd
HERTUZU trastuzumab (rch) 440 mg powder for injection for intravenous infusion vial with diluent Cancelled under Section 30(1)(c) of the Act

23 June 2023

Cancellation by sponsor

Requested by Celltrion Healthcare Australia Pty Ltd
SIMABTRA trastuzumab (rch) 150 mg powder for injection for intravenous infusion vial Cancelled under Section 30(1)(c) of the Act

23 June 2023

Cancellation by sponsor

Requested by Celltrion Healthcare Australia Pty Ltd
HERTUZU trastuzumab (rch) 150 mg powder for injection for intravenous infusion vial Cancelled under Section 30(1)(c) of the Act

23 June 2023

Cancellation by sponsor

Requested by Celltrion Healthcare Australia Pty Ltd

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The Department of Health and Aged Care 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.