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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 121 to 130

BYDUREON exenatide 2 mg powder for injection vial with diluent syringe Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
VIBRENT rosuvastatin (as calcium) 20mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
VIBRENT rosuvastatin (as calcium) 10mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
VIBRENT rosuvastatin (as calcium) 5mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
TALEXAR rosuvastatin (as calcium) 40mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
TALEXAR rosuvastatin (as calcium) 20mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
AFFORA rosuvastatin (as calcium) 40mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
AFFORA rosuvastatin (as calcium) 20mg film-coated tablet blister pack Cancelled under Section 30(1)(c) of the Act

29 June 2022

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
AusPAR: Trastuzumab deruxtecan

27 June 2022

Australian public assessment report (AusPar)

Enhertu (trastuzumab deruxtecan) for treatment of unresectable or metastatic HER2 positive breast cancer.
Notice for trastuzumab deruxtecan (AstraZeneca Pty Ltd)

18 May 2022

Designation or determination

Priority review

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