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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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412 result(s) found, displaying 61 to 70

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.
Rotarix Vaccine Cancelled under Section 30(1)(c) of the Act

12 July 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
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.
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
ZOVIRAX Aciclovir 200mg 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
ZOVIRAX Aciclovir 500 mg (as sodium) powder for injection vial Cancelled under Section 30(1)(c) of the Act

3 June 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
SYNFLORIX pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed suspension for injection pre-filled syringe Cancelled under Section 30(1)(c) of the Act

1 June 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
SYNFLORIX pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed suspension for injection vial Cancelled under Section 30(1)(c) of the Act

1 June 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
ROTARIX human rotavirus (live attenuated oral vaccine ) powder for oral liquid plus diluent syringe Cancelled under Section 30(1)(c) of the Act

1 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.