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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 31 to 40

BOOSTRIX-IPV (GlaxoSmithKline Australia Pty Ltd)

27 February 2025

Prescription medicine registration

Active ingredients: Diphtheria toxoid, Pertactin, Pertussis filamentous haemagglutinin, Pertussis toxoid, Poliovirus, Tetanus toxoid.
ROTARIX human rotavirus (live attenuated oral vaccine) oral liquid tube (multi-monodose) Cancelled under Section 30(1)(c) of the Act

30 January 2025

Cancellation by sponsor

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

7 January 2025

Cancellation by sponsor

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

7 January 2025

Cancellation by sponsor

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

7 January 2025

Cancellation by sponsor

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

17 December 2024

Prescription medicine registration

Active ingredients: momelotinib dihydrochloride monohydrate.
AREXVY Recombinant Respiratory Syncytial Virus pre-fusion F protein vaccine 120 micrograms powder vial and suspension vial suspension for injection (400657)

14 January 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for AREXVY Recombinant Respiratory Syncytial Virus pre-fusion F protein vaccine 120 micrograms powder vial and suspension vial suspension for injection.
EVOCAIR MDI 50/25 fluticasone propionate 50 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose (with counter) Cancelled under Section 30(1)(c) of the Act

15 October 2024

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
MENVEO Meningococcal (Groups A,C,W-135 and Y) Oligosaccharide CRM197 solution for injection vial (393321)

26 September 2023

ARTG

Australian Register of Therapeutic Goods (ARTG) information for MENVEO Meningococcal (Groups A,C,W-135 and Y) Oligosaccharide CRM197 solution for injection vial.
XEVUDY sotrovimab 500 mg/8 mL concentrated injection solution for infusion, vial Cancelled under Section 30(1)(c) of the Act

12 September 2024

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd

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