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Gilead Sciences Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (30)
Australian public assessment report (AusPar) (29)
Prescription medicine registration (19)
Cancellation by sponsor (16)
Designation or determination (7)
Prescription medicine decision summary (5)

Date

2026 (6)
2025 (4)
2024 (9)
2023 (7)
2022 (16)
2021 (14)
2020 (6)
2019 (2)
2018 (6)
2017 (6)
2016 (8)
2015 (5)
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1996 (1)

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Sponsor content

106 result(s) found, displaying 41 to 50

Gilead Sciences Pty Ltd - Nebulizer, non-heated Cancelled under Section 41GL(d) of the Act

14 April 2022

Cancellation by sponsor

Requested by Gilead Sciences Pty Ltd
Gilead Sciences Pty Ltd - Nebulizer, non-heated Cancelled under Section 41GL(d) of the Act

14 April 2022

Cancellation by sponsor

Requested by Gilead Sciences Pty Ltd
AusPAR: Sacituzumab govitecan

29 March 2022

Australian public assessment report (AusPar)

New AusPAR for Trodelvy (sacituzumab govitecan) for the treatment of breast cancer.
Notice for lenacapavir (Gilead Sciences Pty Ltd)

2 February 2022

Designation or determination

Priority review
Notice for bulevirtide (Gilead Sciences Pty Ltd)

19 January 2022

Designation or determination

Orphan drug
Notice for bulevirtide (Gilead Sciences Pty Ltd)

19 January 2022

Designation or determination

Priority review
ATRIPLA 300 mg tenofovir disoproxil fumarate/200 mg emtricitabine/600 mg efavirenz tablets bottle Cancelled under Section 30(1)(c) of the Act

20 December 2021

Cancellation by sponsor

Requested by Gilead Sciences Pty Ltd
AusPAR: Sofosbuvir/velpatasvir

21 September 2021

Australian public assessment report (AusPar)

Australian Public Assessment Report for Sofosbuvir/velpatasvir
Trodelvy

14 September 2021

Prescription medicine decision summary

Australian prescription medicine decision summary
TRODELVY (Gilead Sciences Pty Ltd)

3 September 2021

Prescription medicine registration

Active ingredients: sacituzumab govitecan.

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