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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)
Prescription medicine evaluation (1)

Date

2026 (1)
2025 (22)
2024 (10)
2023 (18)
2022 (6)
2021 (4)
2020 (5)
2019 (1)
2018 (3)
2015 (1)

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Sponsor content

71 result(s) found, displaying 51 to 60

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
RITEMVIA 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
RITUZENA 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
SIMABTRA 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
AusPAR: Yuflyma

9 November 2022

Australian public assessment report (AusPar)

AusPAR for Yuflyma (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis etc.
Celltrion Healthcare Australia Pty Ltd - Skin-cleaning wipe, sterile (360071)

7 April 2021

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Celltrion Healthcare Australia Pty Ltd - Skin-cleaning wipe, sterile.
Celltrion Healthcare Australia Pty Ltd - Antiseptic swab (351320)

9 December 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Celltrion Healthcare Australia Pty Ltd - Antiseptic swab.
REMSIMA infliximab 120 mg solution for injection prefilled syringe (326143)

12 November 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for REMSIMA infliximab 120 mg solution for injection prefilled syringe.
REMSIMA infliximab 120 mg solution for injection prefilled syringe with safety guard (326187)

12 November 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for REMSIMA infliximab 120 mg solution for injection prefilled syringe with safety guard.
REMSIMA infliximab 120 mg solution for injection prefilled syringe in auto-injector pen (326188)

12 November 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for REMSIMA infliximab 120 mg solution for injection prefilled syringe in auto-injector pen.

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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.