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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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Sponsor content

412 result(s) found, displaying 81 to 90

GlaxoSmithKline Australia Pty Ltd - Inhaler, aerosol, portable Cancelled under Section 41GL(d) of the Act

1 June 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
GlaxoSmithKline Australia Pty Ltd - Injector, medication/vaccine, needleless, mechanically-powered Cancelled under Section 41GL(d) of the Act

1 June 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
GlaxoSmithKline Australia Pty Ltd - Inhaler, aerosol, portable Cancelled under Section 41GL(d) of the Act

1 June 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
GlaxoSmithKline Australia Pty Ltd - Inhaler, aerosol, portable Cancelled under Section 41GL(d) of the Act

1 June 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
GlaxoSmithKline Australia Pty Ltd - Inhaler, aerosol, portable Cancelled under Section 41GL(d) of the Act

1 June 2022

Cancellation by sponsor

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

8 March 2022

Prescription medicine registration

Active ingredients: tafenoquine succinate.
Jemperli

2 March 2022

Prescription medicine decision summary

TGA decision: Jemperli (dostarlimab) is approved to treat patients with recurrent or advanced mismatch repair deficient endometrial cancer.
JEMPERLI (GlaxoSmithKline Australia Pty Ltd)

15 February 2022

Prescription medicine registration

Active ingredients: dostarlimab.
JEMPERLI (GlaxoSmithKline Australia Pty Ltd)

15 February 2022

Prescription medicine registration

Active ingredients: dostarlimab.
NUCALA (GlaxoSmithKline Australia Pty Ltd)

11 January 2022

Prescription medicine registration

Active ingredients: mepolizumab.

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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.