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Amgen Australia Pty Ltd

Regulatory activities for this sponsor.

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ARTG (83) ARTG (83)
Cancellation by sponsor (39) Cancellation by sponsor (39)
Australian Public Assessment Report (AusPAR) (17)
Prescription medicine registration (16)
Designation or determination (6) Designation or determination (6)
Prescription medicine decision summary (3)
Prescription medicine evaluation (3) Prescription medicine evaluation (3)

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167 result(s) found, displaying 31 to 40

Notice for Tarlatamab (Amgen Australia Pty Ltd)

22 April 2024

Designation or determination

Provisional determination
Tepezza Amgen Australia Pty Ltd

Apr-2024

Prescription medicine evaluation

Active ingredient: teprotumumab.
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

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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.

Amgen Australia Pty Ltd

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