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Amgen Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (80)
Cancellation by sponsor (39)
Australian Public Assessment Report (AusPAR) (17)
Prescription medicine registration (13)
Designation or determination (6)
Prescription medicine evaluation (4)
Prescription medicine decision summary (3)

Date

2024 (31)
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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162 result(s) found, displaying 41 to 50

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.
AusPAR: Lumakras

30 May 2023

Australian Public Assessment Report (AusPAR)

AusPAR for Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy for advanced disease.
Notice for sotorasib (Amgen Australia Pty Ltd)

13 April 2023

Designation or determination

Orphan drug
REPATHA evolocumab (rch) 420mg/3.5mL injection solution automated mini-doser Cancelled under Section 30(1)(c) of the Act

15 March 2023

Cancellation by sponsor

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

17 February 2023

Prescription medicine registration

Active ingredients: carfilzomib.

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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.