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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 141 to 150

GlaxoSmithKline Australia Pty Ltd - Dispenser, medication, liquid Cancelled under Section 41GL(d) of the Act

14 December 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
FLOLAN epoprostenol sodium 500 microgram 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
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
SHINGRIX Recombinant Varicella Zoster Virus glycoprotein E antigen vaccine 50 micrograms powder vial and suspension vial for suspension for injection (289257)

2 July 2018

ARTG

Australian Register of Therapeutic Goods (ARTG) information for SHINGRIX Recombinant Varicella Zoster Virus glycoprotein E antigen vaccine 50 micrograms powder vial and suspension vial for suspension for injection.
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

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