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GlaxoSmithKline Australia Pty Ltd

Regulatory activities for this sponsor.

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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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412 result(s) found, displaying 171 to 180

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

18 February 2020

Australian Public Assessment Report (AusPAR)

Australian Public Assessment Report for Mepolizumab
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.
AusPAR: Mepolizumab

24 October 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
VARILRIX varicella vaccine live attenuated 0.5mL injection vial plus diluent syringe composite pack Cancelled under Section 30(1)(c) of the Act

31 July 2019

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
VARILRIX varicella vaccine live attenuated 0.5mL injection vial plus diluent ampoule composite pack Cancelled under Section 30(1)(c) of the Act

31 July 2019

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
VARILRIX varicella vaccine live attenuated 0.5mL powder for injection vial Cancelled under Section 30(1)(c) of the Act

31 July 2019

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
ZOVIRAX ACICLOVIR 800mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

28 June 2019

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
ZOVIRAX aciclovir 200mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

28 June 2019

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.