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GlaxoSmithKline Australia Pty Ltd

Regulatory activities for this sponsor.

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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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424 result(s) found, displaying 81 to 90

INFANRIX diphtheria toxoid / pertactin / pertussis filamentous haemagglutinin / pertussis toxoid / tetanus toxoid 0.5mL injection vial Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
HAVRIX JUNIOR inactivated hepatitis A vaccine 720 ELISA units/0.5mL injection vial Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
MENVEO meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine Cancelled under Section 30(1)(c) of the Act

16 November 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.
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

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