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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 191 to 200

Valtrex Tablets Cancelled under Section 30(1)(c) of the Act

15 July 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
Zeffix 100mg Tablets Cancelled under Section 30(1)(c) of the Act

15 July 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
Naramig Tablets 2.5mg Cancelled under Section 30(1)(c) of the Act

15 July 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
TYKERB Lapatinib 250mg (as ditosylate monohydrate) tablets bottle pack (EXPORT ONLY) Cancelled under Section 30(1)(c) of the Act

15 July 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
TYKERB Lapatinib 250mg (as ditosylate monohydrate) tablet Blister Pack (EXPORT ONLY) Cancelled under Section 30(1)(c) of the Act

15 July 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
TRELEGY ELLIPTA 100/62.5/25 fluticasone furoate 100 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation (284636)

16 January 2018

ARTG

Australian Register of Therapeutic Goods (ARTG) information for TRELEGY ELLIPTA 100/62.5/25 fluticasone furoate 100 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation.
MENJUGATE SYRINGE meningococcal C conjugate vaccine 10microgram/0.5mL powder for injection with diluent Cancelled under Section 30(1)(c) of the Act

18 May 2020

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AusPAR: Mepolizumab

5 March 2020

Australian public assessment report (AusPar)

Australian Public Assessment Report for Mepolizumab
AusPAR: Mepolizumab

21 November 2019

Australian public assessment report (AusPar)

Australian Public Assessment Report Mepolizumab
WARTEC CREAM podophyllotoxin 1.5mg/g tube Cancelled under Section 30(1)(c) of the Act

10 September 2019

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.