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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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2024 (10)
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Sponsor content

412 result(s) found, displaying 31 to 40

AusPAR: Jemperli

6 February 2023

Australian Public Assessment Report (AusPAR)

New AusPAR for Jemperli (dostarlimab) for the treatment of mismatch repair deficient endometrial cancer.
KOZENIS tafenoquine 50 mg film-coated dispersible tablet blister pack (350774)

9 March 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for KOZENIS tafenoquine 50 mg film-coated dispersible tablet blister pack.
JEMPERLI dostarlimab 500 mg concentrate for solution for infusion 10 mL vial (352631)

17 February 2022

ARTG

Australian Register of Therapeutic Goods (ARTG) information for JEMPERLI dostarlimab 500 mg concentrate for solution for infusion 10 mL vial.
AusPAR: Kozenis

13 December 2022

Australian Public Assessment Report (AusPAR)

AusPAR for Kozenis (tafenoquine) for prevention of relapse of Plasmodium vivax malaria in combination with chloroquine.
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
HAVRIX 1440 hepatitis A vaccine inactivated 1440 ELISA units/1mL injection vial Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
TWINRIX JUNIOR (combined hepatitis A & hepatitis B vaccine) 0.5 mL injection vial thiomersal & preservative free. Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
TWINRIX (combined hepatitis A & hepatitis B vaccine) 1 mL injection vial thiomersal & preservative free Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
ENGERIX-B PAEDIATRIC DOSE hepatitis B surface antigen recombinant (yeast) 10 microgram/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

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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.