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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)
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Sponsor content

175 result(s) found, displaying 31 to 40

WEZLANA ustekinumab 45 mg / 0.5 mL solution for subcutaneous injection pre-filled syringe (403013)

22 January 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for WEZLANA ustekinumab 45 mg / 0.5 mL solution for subcutaneous injection pre-filled syringe.
RISTEMPA pegfilgrastim (rbe) 6mg/0.6mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
NEULASTA pegfilgrastim (rbe) 6mg/0.6mL injection syringe with automatic needle guard Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
NEUPOGEN filgrastim (rbe) 480 microgram/0.5mL injection syringe Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
NEUPOGEN filgrastim (rbe) 300 microgram/0.5mL injection syringe Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
NEUPOGEN filgrastim (rbe) 300 microgram/1mL injection vial Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
NEUPOGEN filgrastim (rbe) 480 microgram/1.6mL injection vial Cancelled under Section 30(1)(c) of the Act

28 June 2024

Cancellation by sponsor

Requested by Amgen Australia Pty Ltd
AusPAR: Wezlana

27 June 2024

Australian public assessment report (AusPar)

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

22 April 2024

Designation or determination

Provisional determination

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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.