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Amgen Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (89)
Cancellation by sponsor (39)
Australian public assessment report (AusPar) (19)
Prescription medicine registration (17)
Designation or determination (8)
Prescription medicine decision summary (3)

Date

2025 (16)
2024 (28)
2023 (19)
2022 (11)
2021 (7)
2020 (6)
2019 (12)
2018 (8)
2017 (4)
2016 (4)
2015 (10)
2014 (2)
2012 (1)
2011 (3)
2010 (14)
2008 (4)
2006 (13)
2002 (1)
2001 (12)

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Sponsor content

175 result(s) found, displaying 51 to 60

ANGEVOUR darbepoetin alfa (rch) 10 microgram/0.4mL injection syringe Cancelled under Section 30(1)(c) of the Act

11 September 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
ANGEVOUR darbepoetin alfa (rch) 500 microgram/1.0mL solution for injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

11 September 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
ANGEVOUR darbepoetin alfa (rch) 300 microgram/0.6mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

11 September 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
ANGEVOUR darbepoetin alfa (rch) 200 microgram/0.4mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

11 September 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
ANGEVOUR darbepoetin alfa (rch) 150 microgram/0.3mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

11 September 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
ANGEVOUR darbepoetin alfa (rch) 100 microgram/0.5mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

11 September 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
ANGEVOUR darbepoetin alfa (rch) 80 microgram/0.4mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

11 September 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
ANGEVOUR darbepoetin alfa (rch) 60 microgram/0.3mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

11 September 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
OTEZLA (Amgen Australia Pty Ltd)

29 August 2023

Prescription medicine registration

Active ingredients: apremilast.
LUMAKRAS sotorasib 120 mg tablet blister pack (353210)

30 March 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for LUMAKRAS sotorasib 120 mg tablet blister pack.

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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.