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GlaxoSmithKline Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

Cancellation by sponsor (243)
ARTG (107)
Australian public assessment report (AusPar) (41)
Prescription medicine registration (20)
Designation or determination (5)
Prescription medicine evaluation (4)
Prescription medicine decision summary (3)
Face mask cancellation (1)

Date

2025 (25)
2024 (13)
2023 (18)
2022 (61)
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2020 (59)
2019 (30)
2018 (27)
2017 (24)
2016 (11)
2015 (49)
2014 (21)
2013 (9)
2012 (6)
2011 (4)
2010 (7)
2009 (3)
2008 (6)
2007 (5)
2006 (3)
2005 (4)
2004 (1)
2003 (3)
2002 (1)
2001 (1)
2000 (3)
1999 (1)
1998 (5)
1997 (4)
1995 (1)
1991 (6)

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Sponsor content

424 result(s) found, displaying 21 to 30

AREXVY (GlaxoSmithKline Australia Pty Ltd)

27 March 2025

Prescription medicine registration

Active ingredients: recombinant respiratory syncytial virus pre-fusion F protein.
FLOLAN epoprostenol sodium 1.5 mg powder for injection vial with diluent vial Cancelled under Section 30(1)(c) of the Act

19 March 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
FLOLAN epoprostenol sodium 500 microgram powder for injection vial with diluent vial Cancelled under Section 30(1)(c) of the Act

19 March 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
BOOSTRIX-IPV (GlaxoSmithKline Australia Pty Ltd)

27 February 2025

Prescription medicine registration

Active ingredients: Diphtheria toxoid, Pertactin, Pertussis filamentous haemagglutinin, Pertussis toxoid, Poliovirus, Tetanus toxoid.
ROTARIX human rotavirus (live attenuated oral vaccine) oral liquid tube (multi-monodose) Cancelled under Section 30(1)(c) of the Act

30 January 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AIRZATE MDI 250/25 fluticasone propionate 250 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose (with counter) Cancelled under Section 30(1)(c) of the Act

7 January 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AIRZATE MDI 125/25 fluticasone propionate 125 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose (with counter) Cancelled under Section 30(1)(c) of the Act

7 January 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AIRZATE MDI 50/25 fluticasone propionate 50 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose (with counter) Cancelled under Section 30(1)(c) of the Act

7 January 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
OMJJARA (GlaxoSmithKline Australia Pty Ltd)

17 December 2024

Prescription medicine registration

Active ingredients: momelotinib dihydrochloride monohydrate.
EVOCAIR MDI 50/25 fluticasone propionate 50 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose (with counter) Cancelled under Section 30(1)(c) of the Act

15 October 2024

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd

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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.