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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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322 result(s) found, displaying 181 to 190

Notice for selumetinib (AstraZeneca Pty Ltd)

30 July 2020

Designation or determination

Orphan drug
Notice for trastuzumab deruxtecan (AstraZeneca Pty Ltd)

22 July 2020

Designation or determination

Provisional approval
RILAST TURBUHALER 400/12 powder for inhalation dry powder inhaler (295675)

22 December 2017

ARTG

Australian Register of Therapeutic Goods (ARTG) information for RILAST TURBUHALER 400/12 powder for inhalation dry powder inhaler.
RILAST TURBUHALER 100/6 powder for inhalation dry powder inhaler (295673)

22 December 2017

ARTG

Australian Register of Therapeutic Goods (ARTG) information for RILAST TURBUHALER 100/6 powder for inhalation dry powder inhaler.
RILAST TURBUHALER 200/6 powder for inhalation dry powder inhaler (295674)

22 December 2017

ARTG

Australian Register of Therapeutic Goods (ARTG) information for RILAST TURBUHALER 200/6 powder for inhalation dry powder inhaler.
PULMICORT Respules budesonide 0.125mg/mL nebuliser suspension (297787)

19 December 2017

ARTG

Australian Register of Therapeutic Goods (ARTG) information for PULMICORT Respules budesonide 0.125mg/mL nebuliser suspension.
PULMICORT Respules budesonide 0.5mg/mL suspension for inhalation ampoule (297786)

19 December 2017

ARTG

Australian Register of Therapeutic Goods (ARTG) information for PULMICORT Respules budesonide 0.5mg/mL suspension for inhalation ampoule.
PULMICORT Respules budesonide 0.125mg/mL suspension for inhalation ampoule (297784)

19 December 2017

ARTG

Australian Register of Therapeutic Goods (ARTG) information for PULMICORT Respules budesonide 0.125mg/mL suspension for inhalation ampoule.
PULMICORT Respules budesonide 0.25mg/mL suspension for inhalation ampoule (297785)

19 December 2017

ARTG

Australian Register of Therapeutic Goods (ARTG) information for PULMICORT Respules budesonide 0.25mg/mL suspension for inhalation ampoule.
FORXIGA (AstraZeneca Pty Ltd)

15 April 2020

Prescription medicine registration

Active ingredients: dapagliflozin propanediol monohydrate.

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