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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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Sponsor content

162 result(s) found, displaying 61 to 70

LUMAKRAS (Amgen Australia Pty Ltd)

28 March 2022

Prescription medicine registration

Active ingredients: sotorasib.
REPATHA evolocumab (rch) 420 mg/3.5 mL injection solution automated mini-doser AMD (348651)

3 December 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for REPATHA evolocumab (rch) 420 mg/3.5 mL injection solution automated mini-doser AMD.
MVASI bevacizumab 100 mg/4 mL injection concentrated vial (297455)

30 June 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for MVASI bevacizumab 100 mg/4 mL injection concentrated vial.
MVASI bevacizumab 400 mg/16 mL injection concentrated vial (297456)

30 June 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for MVASI bevacizumab 400 mg/16 mL injection concentrated vial.
Amgen Australia Pty Ltd - Medicine administration kit Cancelled under Section 41GL(d) of the Act

18 November 2021

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
Amgen Australia Pty Ltd - Clinical information system web-based application software Cancelled under Section 41GL(d) of the Act

29 October 2021

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
Amgen Australia Pty Ltd - Clinical information system web-based application software Cancelled under Section 41GL(d) of the Act

29 October 2021

Cancellation by sponsor

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

15 October 2021

Prescription medicine registration

Active ingredients: romiplostim.
IMLYGIC talimogene laherparepvec one million PFU/mL injection solution vial Cancelled under Section 30(1)(c) of the Act

19 July 2021

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
IMLYGIC talimogene laherparepvec one hundred million PFU/mL injection solution vial Cancelled under Section 30(1)(c) of the Act

19 July 2021

Cancellation by sponsor

Requested by Amgen 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.