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AstraZeneca Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (108)
Cancellation by sponsor (70)
Prescription medicine registration (56)
Australian public assessment report (AusPar) (46)
Designation or determination (23)
Prescription medicine decision summary (11)
Prescription medicine evaluation (7)
Section 14, TGO91 consent (1)

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Sponsor content

322 result(s) found, displaying 11 to 20

Tezspire tezepelumab 210 mg in 1.91mL solution for Injection prefilled pen (432812)

24 March 2025

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Tezspire tezepelumab 210 mg in 1.91mL solution for Injection prefilled pen.
Tezspire, tezepelumab 210 mg in 1.91mL solution for Injection prefilled syringe (427956)

24 March 2025

ARTG

Australian Register of Therapeutic Goods (ARTG) information for Tezspire, tezepelumab 210 mg in 1.91mL solution for Injection prefilled syringe.
TRADENAME AstraZeneca Pty Ltd

Jul-2025

Prescription medicine evaluation

Active ingredient: camizestrant.
Notice for durvalumab (AstraZeneca Pty Ltd)

11 June 2025

Designation or determination

Priority review
ASTRAZENECA GOSERELIN goserelin 10.8mg (as acetate) implant syringe Cancelled under Section 30(1)(c) of the Act

3 June 2025

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
ASTRAZENECA GOSERELIN goserelin 3.6mg (as acetate) implant syringe Cancelled under Section 30(1)(c) of the Act

3 June 2025

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
WAINUA AstraZeneca Pty Ltd

Jun-2025

Prescription medicine evaluation

Active ingredient: eplontersen sodium.
AstraZeneca Pty Ltd - Medicine administration kit, percutaneous, medicated, single-use Cancelled under Section 41GL(d) of the Act

28 May 2025

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
FASLODEX fulvestrant 250mg/5mL solution for injection pre-filled syringe Cancelled under Section 30(1)(c) of the Act

28 May 2025

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
ENHERTU (AstraZeneca Pty Ltd)

27 May 2025

Prescription medicine registration

Active ingredients: trastuzumab deruxtecan.

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