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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)
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418 result(s) found, displaying 71 to 80

PRIORIX ALBUMIN FREE VACCINE 0.5mL powder for injection vial and diluent ampoule Cancelled under Section 30(1)(c) of the Act

3 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
PRIORIX ALBUMIN FREE VACCINE 0.5mL powder for injection vial Cancelled under Section 30(1)(c) of the Act

3 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
FLIXOTIDE JUNIOR ACCUHALER fluticasone propionate 50 micrograms powder for inhalation blister pack Cancelled under Section 30(1)(c) of the Act

21 October 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
EVOCAIR MDI 250/25 fluticasone propionate 250 microgram/salmeterol (as xinafoate) 25 microgram inhalation - pressurised aerosol can - metered dose Cancelled under Section 30(1)(c) of the Act

21 October 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
EVOCAIR MDI 125/25 fluticasone propionate 125 microgram/salmeterol (as xinafoate) 25 microgram inhalation - pressurised aerosol can - metered dose Cancelled under Section 30(1)(c) of the Act

21 October 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
EVOCAIR MDI 50/25 fluticasone propionate 50 microgram/salmeterol (as xinafoate) 25 microgram inhalation - pressurised aerosol can - metered dose Cancelled under Section 30(1)(c) of the Act

21 October 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
BENLYSTA (GlaxoSmithKline Australia Pty Ltd)

29 September 2022

Prescription medicine registration

Active ingredients: Belimumab.
TRELEGY ELLIPTA 200/62.5/25 fluticasone furoate 200 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation (335858)

10 May 2021

ARTG

Australian Register of Therapeutic Goods (ARTG) information for TRELEGY ELLIPTA 200/62.5/25 fluticasone furoate 200 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation.
Rotarix Vaccine Cancelled under Section 30(1)(c) of the Act

12 July 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
ZOVIRAX aciclovir 800mg dispersible tablet blister pack Cancelled under Section 30(1)(c) of the Act

3 June 2022

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.

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