Mega menu

Home
Product regulation
Product regulation

Understand your obligations and access industry Guidance and other information about the products we regulate.
Safety and shortages
Safety and shortages

Access information about product recalls, shortages and other alerts, and learn how we manage safety.
Resources and guidance
Resources and guidance

Get information to help you understand our work, regulations and industry obligations.
Business services
Business services

Access our systems to submit applications, manage forms, make payments and communicate securely.

Amgen Australia Pty Ltd

Regulatory activities for this sponsor.

- LinkedIn
- (Twitter)
- Facebook
- Email

Loading...

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)

Search

Sponsor content

175 result(s) found, displaying 41 to 50

Notice for Teprotumumab (Amgen Australia Pty Ltd)

20 March 2024

Designation or determination

Priority Review
Notice for Tarlatamab (Amgen Australia Pty Ltd)

13 March 2024

Designation or determination

Orphan Drug
Wezlana (ustekinumab)

30 January 2024

Prescription medicine decision summary

Wezlana (ustekinumab) has been approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
WEZLANA (Amgen Australia Pty Ltd)

18 January 2024

Prescription medicine registration

Active ingredients: Ustekinumab.
TEZMOTA pegfilgrastim (rbe) 6mg/0.6mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

19 November 2023

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
ANGEVOUR darbepoetin alfa (rch) 50 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) 40 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) 30 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) 20 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) 15 microgram/0.38mL 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

Pages

First page
Previous page
Page 1
Page 2
Page 3
Page 4
Current page 5
Page 6
Page 7
Page 8
Page 9
…
Next page
Last page

Is there anything wrong with this page?

Help us improve

Using our website

Accessibility
Privacy
Security
Disclaimer
Copyright
Freedom of information
Acronyms and glossary terms

Quick links

Search our databases
Report a problem or side effect
TGA Business Services
Special Access Scheme
Authorised Prescriber
Office of Drug Control
State and territory contacts

Connect with us

Email subscriptions
Contact us
Facebook
(formerly Twitter)
Youtube
Instagram
LinkedIn

Help us improve

We are always looking for ways to improve our website.

Provide feedback

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.