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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 51 to 60

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.
Amgen Australia Pty Ltd - Subcutaneous/intramuscular injection set, medicated (385655)

15 March 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Amgen Australia Pty Ltd - Subcutaneous/intramuscular injection set, medicated.
SENSIPAR cinacalcet 90mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

31 October 2022

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
SENSIPAR cinacalcet 60mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

31 October 2022

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
SENSIPAR cinacalcet 30mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

31 October 2022

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
Amgen Australia Pty Ltd - Medicine administration kit, percutaneous, non-medicated, single-use Cancelled under Section 41GL(d) of the Act

29 June 2022

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
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).

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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.