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Celltrion Healthcare Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (38)
Cancellation by sponsor (14)
Prescription medicine registration (8)
Australian public assessment report (AusPar) (7)
Prescription medicine decision summary (2)
Designation or determination (1)

Date

2026 (1)
2025 (21)
2024 (10)
2023 (18)
2022 (6)
2021 (4)
2020 (5)
2019 (1)
2018 (3)
2015 (1)

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Sponsor content

70 result(s) found, displaying 41 to 50

YUFLYMA adalimumab (rch) 40 mg/0.4 mL solution for injection pre-filled syringe in autoinjector (367771)

25 March 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for YUFLYMA adalimumab (rch) 40 mg/0.4 mL solution for injection pre-filled syringe in autoinjector.
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
RITEMVIA 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

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