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GlaxoSmithKline Australia Pty Ltd

Regulatory activities for this sponsor.

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Cancellation by sponsor (234) Cancellation by sponsor (234)
ARTG (112) ARTG (112)
Australian Public Assessment Report (AusPAR) (41)
Prescription medicine registration (19)
Designation or determination (5) Designation or determination (5)
Prescription medicine decision summary (3)
Prescription medicine evaluation (3) Prescription medicine evaluation (3)
Face mask cancellation (1) Face mask cancellation (1)

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418 result(s) found, displaying 11 to 20

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
BLENREP GlaxoSmithKline Australia Pty Ltd

Jan-2025

Prescription medicine evaluation

Active ingredient: belantamab mafodotin.
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
XEVUDY sotrovimab 500 mg/8 mL concentrated injection solution for infusion, vial Cancelled under Section 30(1)(c) of the Act

12 September 2024

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AREXVY Recombinant Respiratory Syncytial Virus pre-fusion F protein vaccine 120 micrograms powder vial and suspension vial suspension for injection (400657)

14 January 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for AREXVY Recombinant Respiratory Syncytial Virus pre-fusion F protein vaccine 120 micrograms powder vial and suspension vial suspension for injection.
AusPAR: Arexvy

3 May 2024

Australian Public Assessment Report (AusPAR)

Arexvy is a vaccine approved for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older
GlaxoSmithKline Australia Pty Ltd - Medicine chamber spacer Cancelled under Section 41GL(d) of the Act

23 April 2024

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
GlaxoSmithKline Australia Pty Ltd - Scalpel, one-piece, single use Cancelled under Section 41GL(d) of the Act

23 April 2024

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd

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The Department of Health and Aged Care 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.

GlaxoSmithKline Australia Pty Ltd

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