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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 121 to 130

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
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
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.
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.