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AstraZeneca Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (111)
Cancellation by sponsor (70)
Prescription medicine registration (60)
Australian public assessment report (AusPar) (48)
Designation or determination (24)
Prescription medicine decision summary (12)
Prescription medicine evaluation (10)
Section 14, TGO91 consent (1)

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Sponsor content

336 result(s) found, displaying 261 to 270

KOMBIGLYZE 2.5/1000 saxagliptin (as hydrochloride)/metformin hydrochloride 2.5 mg/1000 mg immediate release film-coated tablet blister Cancelled under Section 30(1)(c) of the Act

18 August 2016

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
KOMBIGLYZE 2.5/500 saxagliptin (as hydrochloride)/metformin hydrochloride 2.5 mg/500 mg immediate release film-coated tablet blister Cancelled under Section 30(1)(c) of the Act

18 August 2016

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
KOMBIGLYZE 2.5/850 saxagliptin (as hydrochloride)/metformin hydrochloride 2.5 mg/850 mg immediate release film-coated tablet blister Cancelled under Section 30(1)(c) of the Act

18 August 2016

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film-coated tablet blister pack (180147)

22 October 2012

ARTG

Australian Register of Therapeutic Goods (ARTG) information for FORXIGA dapagliflozin (as propanediol monohydrate) 10 mg film-coated tablet blister pack.
AusPAR: Naloxegol oxalate

6 June 2016

Australian public assessment report (AusPar)

Australian Public Assessment Report for Naloxegol oxolate
SYMBICORT RAPIHALER budesonide / formoterol fumarate dihydrate 100/3 pressurised metered dose inhaler (158899)

26 July 2012

ARTG

Australian Register of Therapeutic Goods (ARTG) information for SYMBICORT RAPIHALER budesonide / formoterol fumarate dihydrate 100/3 pressurised metered dose inhaler.
XYLOCAINE 2% With Adrenaline 1:80,000 (Ampoule) (Lignocaine + Adrenaline) Cancelled under s30(1)(c) of the Act

19 November 2015

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
Xylocaine 5% Adhesive Ointment (lignocaine) Cancelled under s30(1)(c) of the Act

19 November 2015

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
XYLOCAINE 1.5% lignocaine hydrochloride 375mg/25mL injection ampoule Cancelled under s30(1)(c) of the Act

19 November 2015

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd
MARCAIN 0.75% bupivacaine hydrochloride 75mg/10mL injection ampoule Cancelled under s30(1)(c) of the Act

19 November 2015

Cancellation by sponsor

Requested by AstraZeneca Pty Ltd

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