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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 71 to 80

Amgen Australia Pty Ltd - Thermometer kit Cancelled under Section 41GL(d) of the Act

23 June 2022

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
AMGEN WATER FOR INJECTIONS water for injections 1.2 mL injection solution pre-filled syringe Cancelled under Section 30(1)(c) of the Act

3 June 2022

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
AMGEN WATER FOR INJECTIONS water for injections 0.72 mL injection solution pre-filled syringe Cancelled under Section 30(1)(c) of the Act

3 June 2022

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
Lumakras

13 April 2022

Prescription medicine decision summary

TGA Decision: Lumakras (sotorasib) is approved to treat adult patients with non-small cell lung cancer (NSCLC).
LUMAKRAS (Amgen Australia Pty Ltd)

28 March 2022

Prescription medicine registration

Active ingredients: sotorasib.
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.
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.
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

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