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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 151 to 160

FLOLAN epoprostenol sodium 1.5 mg powder for injection vial Cancelled under Section 30(1)(c) of the Act

14 December 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
BECODERM-C FLARE-UP ECZEMA AND DERMATITIS CREAM clobetasone butyrate 0.5mg/g tube Cancelled under Section 30(1)(c) of the Act

14 December 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
GlaxoSmithKline Australia Pty Ltd - Mask Cancelled under Section 41GL(d) of the Act

20 November 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
Zofran Injection Solution Ampoules 4mg/2mL Cancelled under Section 30(1)(c) of the Act

4 November 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
Zofran Injection 8mg/4mL Cancelled under Section 30(1)(c) of the Act

4 November 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
Notice for tafenoquine (GlaxoSmithKline Australia Pty Ltd)

15 October 2020

Designation or determination

Orphan drug
Notice for dostarlimab (GlaxoSmithKline Australia Pty Ltd)

15 September 2020

Designation or determination

Provisional approval
AVANDAMET 2/500 tablet blister pack Cancelled under Section 30(1)(c) of the Act

24 August 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AVANDAMET 4/500 tablet blister pack Cancelled under Section 30(1)(c) of the Act

24 August 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AVANDAMET rosiglitazone 2mg / metformin 1000mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

24 August 2020

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.