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Gilead Sciences Pty Ltd

Regulatory activities for this sponsor.

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Type

Australian public assessment report (AusPar) (30)
ARTG (29)
Prescription medicine registration (19)
Cancellation by sponsor (16)
Designation or determination (8)
Prescription medicine decision summary (5)
Prescription medicine evaluation (1)

Date

2026 (8)
2025 (5)
2024 (9)
2023 (7)
2022 (16)
2021 (14)
2020 (6)
2019 (2)
2018 (6)
2017 (6)
2016 (8)
2015 (5)
2014 (6)
2013 (3)
2012 (2)
2010 (2)
2005 (1)
2002 (1)
1996 (1)

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Sponsor content

108 result(s) found, displaying 11 to 20

TYBOST 150 mg cobicistat tablets, bottle Cancelled under Section 30(1)(c) of the Act

3 October 2025

Cancellation by sponsor

Requested by Gilead Sciences Pty Ltd
BIKTARVY (Gilead Sciences Pty Ltd)

7 July 2025

Prescription medicine registration

Active ingredients: bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate.
HEPCLUDEX bulevirtide (as acetate) 2 mg powder for injection vial (407179)

30 July 2024

ARTG

Australian Register of Therapeutic Goods (ARTG) information for HEPCLUDEX bulevirtide (as acetate) 2 mg powder for injection vial.
Notice for lenacapavir (LEN) (Gilead Sciences Pty Ltd)

24 March 2025

Designation or determination

Priority review
Gilead Sciences Pty Ltd - Vial transfer spike Cancelled under Section 41GL(d) of the Act

18 October 2024

Cancellation by sponsor

Requested by Gilead Sciences Pty Ltd
Gilead Sciences Pty Ltd - Syringe, general-purpose Cancelled under Section 41GL(d) of the Act

18 October 2024

Cancellation by sponsor

Requested by Gilead Sciences Pty Ltd
Gilead Sciences Pty Ltd - Spoon, medicine, reusable Cancelled under Section 41GL(d) of the Act

18 October 2024

Cancellation by sponsor

Requested by Gilead Sciences Pty Ltd
Gilead Sciences Pty Ltd - Hypodermic needle, single-use, sterile Cancelled under Section 41GL(d) of the Act

18 October 2024

Cancellation by sponsor

Requested by Gilead Sciences Pty Ltd
Hepcludex (bulevirtide acetate)

12 August 2024

Prescription medicine decision summary

Hepcludex (bulevirtide acetate) was approved to treat chronic hepatitis delta virus infection in adults with compensated liver disease.
HEPCLUDEX (Gilead Sciences Pty Ltd)

22 July 2024

Prescription medicine registration

Active ingredients: bulevirtide acetate.

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