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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)

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Sponsor content

424 result(s) found, displaying 251 to 260

SKB STERILE DILUENT for reconstitution of lyophilised vaccine multidose injection vial Cancelled under s30(1)(c) of the Act

16 January 2018

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
SKB WATER FOR INJECTION ampoule Cancelled under s30(1)(c) of the Act

16 January 2018

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
SKB STERILE DILUENT for reconstitution of Mencevax injection vial Cancelled under s30(1)(c) of the Act

16 January 2018

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
SKB STERILE DILUENT for reconstitution of lyophilised vaccine multidose injection ampoule Cancelled under s30(1)(c) of the Act

16 January 2018

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
TRELEGY ELLIPTA (GlaxoSmithKline Australia Pty Ltd)

9 January 2018

Prescription medicine registration

Active ingredients: fluticasone furoate, umeclidinium bromide, vilanterol trifenatate.
AREPANRIX H5N1 pandemic influenza vaccine suspension for injection 2.5mL vial with adjuvant emulsion 2.5mL vial Cancelled under s30(1)(c)

27 December 2017

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
PANDEMRIX H1N1 pandemic influenza vaccine split virion inactivated AS03 adjuvanted 0.5 mL dose Cancelled under s30(1)(c)

27 December 2017

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
ALTARGO retapamulin 1% w/w ointment tube Cancelled under s30(1)(c)

30 October 2017

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
INCRUSE ELLIPTA umeclidinium (as bromide) 62.5 microgram powder for inhalation (211601)

8 July 2014

ARTG

Australian Register of Therapeutic Goods (ARTG) information for INCRUSE ELLIPTA umeclidinium (as bromide) 62.5 microgram powder for inhalation.
ANORO ELLIPTA 62.5/25 umeclidinium (as bromide)/vilanterol (as trifenatate) 62.5 microgram/25 microgram powder for inhalation (207529)

4 July 2014

ARTG

Australian Register of Therapeutic Goods (ARTG) information for ANORO ELLIPTA 62.5/25 umeclidinium (as bromide)/vilanterol (as trifenatate) 62.5 microgram/25 microgram powder for inhalation.

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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.