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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 (22)
Designation or determination (5)
Prescription medicine decision summary (3)
Prescription medicine evaluation (3)
Face mask cancellation (1)

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Sponsor content

425 result(s) found, displaying 61 to 70

Notice for dostarlimab (GlaxoSmithKline Australia Pty Ltd)

16 February 2023

Designation or determination

Priority review
AusPAR: Jemperli

10 February 2023

Australian public assessment report (AusPar)

New AusPAR for Jemperli (dostarlimab) for the treatment of mismatch repair deficient endometrial cancer.
AusPAR: Kozenis

20 December 2022

Australian public assessment report (AusPar)

AusPAR for Kozenis (tafenoquine) for prevention of relapse of Plasmodium vivax malaria in combination with chloroquine.
TRELEGY ELLIPTA 200/62.5/25 fluticasone furoate 200 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation (335858)

10 May 2021

ARTG

Australian Register of Therapeutic Goods (ARTG) information for TRELEGY ELLIPTA 200/62.5/25 fluticasone furoate 200 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation.
AXOTIDE ACCUHALER fluticasone propionate 500 micrograms powder for inhalation blister pack Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AIRZATE MDI 250/25 fluticasone propionate 250 microgram/salmeterol (as xinafoate) 25 microgram inhalation - pressurised aerosol can - metered dose Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AIRZATE MDI 125/25 fluticasone propionate 125 microgram/salmeterol (as xinafoate) 25 microgram inhalation - pressurised aerosol can - metered dose Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
AIRZATE MDI 50/25 fluticasone propionate 50 microgram/salmeterol (as xinafoate) 25 microgram inhalation - pressurised aerosol can - metered dose Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
PAVTIDE MDI 250/25 fluticasone propionate 250 microgram/salmeterol (as xinafoate) 25 microgram inhalation - pressurised aerosol can - metered dose Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd
PAVTIDE MDI 125/25 fluticasone propionate 125 microgram/salmeterol (as xinafoate) 25 microgram inhalation - pressurised aerosol can - metered dose Cancelled under Section 30(1)(c) of the Act

17 November 2022

Cancellation by sponsor

Requested by GlaxoSmithKline Australia Pty Ltd

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