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GlaxoSmithKline Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

Cancellation by sponsor (244)
ARTG (109)
Australian Public Assessment Report (AusPAR) (42)
Prescription medicine registration (22)
Designation or determination (5)
Prescription medicine decision summary (4)
Prescription medicine evaluation (3)
Face mask cancellation (1)

Date

2026 (7)
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1998 (5)
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Sponsor content

430 result(s) found, displaying 11 to 20

BLENREP (GlaxoSmithKline Australia Pty Ltd)

12 November 2025

Prescription medicine registration

Active ingredients: belantamab mafodotin.
AREXVY GlaxoSmithKline Australia Pty Ltd

Oct-2025

Prescription medicine evaluation

Active ingredient: recombinant respiratory syncytial virus pre-fusion F protein.
FLIXOTIDE NEBULES fluticasone propionate 2.0mg/2mL inhalation ampoule Cancelled under Section 30(1)(c) of the Act

21 October 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
FLIXOTIDE NEBULES fluticasone propionate 0.5mg/2mL inhalation ampoule Cancelled under Section 30(1)(c) of the Act

21 October 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
FLIXONASE NASULE DROPS fluticasone propionate 400mcg unit dose ampoule strip pack Cancelled under Section 30(1)(c) of the Act

21 October 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
VARILRIX HSA-FREE varicella vaccine live attenuated 0.5mL injection vial plus diluent ampoule composite pack Cancelled under Section 30(1)(a) of the Act

24 July 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
VARILRIX HSA-FREE varicella vaccine live attenuated 0.5mL powder for injection vial Cancelled under Section 30(1)(a) of the Act

24 July 2025

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
OMJJARA momelotinib (as dihydrochloride monohydrate) 100 mg film-coated tablet bottle (442230)

18 December 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for OMJJARA momelotinib (as dihydrochloride monohydrate) 100 mg film-coated tablet bottle.
OMJJARA momelotinib (as dihydrochloride monohydrate) 200 mg film-coated tablet bottle (442232)

18 December 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for OMJJARA momelotinib (as dihydrochloride monohydrate) 200 mg film-coated tablet bottle.
OMJJARA momelotinib (as dihydrochloride monohydrate) 150 mg film-coated tablet bottle (442231)

18 December 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for OMJJARA momelotinib (as dihydrochloride monohydrate) 150 mg film-coated tablet bottle.

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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.