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GlaxoSmithKline Australia Pty Ltd

Regulatory activities for this sponsor.

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Type

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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Sponsor content

424 result(s) found, displaying 61 to 70

AusPAR: Jemperli

10 February 2023

Australian public assessment report (AusPar)

New AusPAR for Jemperli (dostarlimab) for the treatment of mismatch repair deficient endometrial cancer.
AusPAR: Kozenis

20 December 2022

Australian public assessment report (AusPar)

AusPAR for Kozenis (tafenoquine) for prevention of relapse of Plasmodium vivax malaria in combination with chloroquine.
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
ENGERIX-B hepatitis B surface antigen recombinant (yeast) 20 microgram/1mL injection vial Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
PRIORIX-TETRA vaccine 0.5mL powder for injection vial with diluent ampoule Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

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

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
SERETIDE MDI 250/25 inhalation - pressurised aerosol can - metered dose 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, Disability and Ageing 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.