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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)

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Sponsor content

430 result(s) found, displaying 51 to 60

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
KOZENIS tafenoquine 50 mg film-coated dispersible tablet blister pack (350774)

9 March 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for KOZENIS tafenoquine 50 mg film-coated dispersible tablet blister pack.
JEMPERLI dostarlimab 500 mg concentrate for solution for infusion 10 mL vial (352631)

17 February 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for JEMPERLI dostarlimab 500 mg concentrate for solution for infusion 10 mL vial.
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
Ventolin Rotacap 200mcg Cancelled under Section 30(1)(c) of the Act

24 May 2023

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
Stieva-A cream 0.01%w/w Cancelled under Section 30(1)(c) of the Act

24 May 2023

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
BOOSTRIX 0.5 mL injection vial Cancelled under Section 30(1)(c) of the Act

8 May 2023

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

4 May 2023

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.