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GlaxoSmithKline Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

Cancellation by sponsor (226)
ARTG (117)
Australian Public Assessment Report (AusPAR) (40)
Prescription medicine registration (17)
Designation or determination (5)
Prescription medicine decision summary (3)
Prescription medicine evaluation (3)
Face mask cancellation (1)

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2024 (10)
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412 result(s) found, displaying 11 to 20

ZEJULA niraparib (as tosilate monohydrate) 100 mg film-coated tablet blister pack (395406)

2 August 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for ZEJULA niraparib (as tosilate monohydrate) 100 mg film-coated tablet blister pack.
AREXVY (GlaxoSmithKline Australia Pty Ltd)

8 January 2024

Prescription medicine registration

Active ingredients: recombinant respiratory syncytial virus pre-fusion F protein.
CERVARIX human papillomavirus vaccine types 16 and 18 [recombinant, AS04 adjuvanted] suspension for injection vial Cancelled under Section 30(1)(c) of the Act

30 November 2023

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
Notice for momelotinib (GlaxoSmithKline Australia Pty Ltd)

25 September 2023

Designation or determination

Orphan drug
VENTOLIN ROTACAPS salbutamol (as sulfate) 200 microgram powder for inhalation strip pack Cancelled under Section 30(1)(c) of the Act

18 August 2023

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
GlaxoSmithKline Australia Pty Ltd - Medicine chamber spacer (398333)

25 October 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for GlaxoSmithKline Australia Pty Ltd - Medicine chamber spacer.
PANDEMRIX H5N1 pandemic influenza vaccine (split virion, inactivated, AS03 adjuvanted) 2.5 mL injection suspension vial composite pack Cancelled under Section 30(1)(c) of the Act

28 June 2023

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
GlaxoSmithKline Australia Pty Ltd - Curette Dermal (396451)

27 September 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for GlaxoSmithKline Australia Pty Ltd - Curette Dermal.
GlaxoSmithKline Australia Pty Ltd - Skin-coring punch, single-use (396430)

26 September 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for GlaxoSmithKline Australia Pty Ltd - Skin-coring punch, single-use.
Ventolin Rotacap 200mcg Cancelled under Section 30(1)(c) of the Act

24 May 2023

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.