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GlaxoSmithKline Australia Pty Ltd

Regulatory activities for this sponsor.

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Cancellation by sponsor (232)
ARTG (116)
Australian Public Assessment Report (AusPAR) (40)
Prescription medicine registration (18)
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Prescription medicine decision summary (3)
Prescription medicine evaluation (3)
Face mask cancellation (1)

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Sponsor content

418 result(s) found, displaying 131 to 140

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
KOZENIS tafenoquine 150 mg film-coated tablet blister pack (297214)

13 September 2018

ARTG

Australian Register of Therapeutic Goods (ARTG) information for KOZENIS tafenoquine 150 mg film-coated tablet blister pack.
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
AVANDAMET rosiglitazone 4mg / 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
MENITORIX combined Hib-MenC conjugate vaccine powder for injection vial plus diluent syringe Cancelled under Section 30(1)(c) of the Act

18 August 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.
Lamictal Standard Tablets 25mg Cancelled under Section 30(1)(c) of the Act

20 July 2020

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.