Product Dossier
VEMLIDY
Product Dossier for VEMLIDY (tenofovir alafenamide, Gilead Sciences). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Gilead Sciences
- Active ingredient: tenofovir alafenamide
- Therapeutic area: Infectious Disease
- Related brand: ODEFSEY
- Related brand: BIKTARVY
- Related brand: DESCOVY
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
VEMLIDY is a tablet containing tenofovir alafenamide 25 mg.
Approved indications
— Chronic hepatitis B.
Key safety warnings
The provided sources do not contain information about safety warnings for VEMLIDY.
PBS listing
VEMLIDY was listed on the PBS with authority required (streamlined) restriction for chronic hepatitis B on a cost-minimisation basis. The PBS listing has since been revoked. The recommendation for PBS listing was extended for 6 months in July 2021, but was revoked in July 2022.
Regulatory history
VEMLIDY was first registered on the ARTG on 22 February 2017 as a 25 mg tablet. In March 2017, the PBAC recommended listing on the PBS with authority required (streamlined) restriction for chronic hepatitis B on a cost-minimisation basis, with comparison to entecavir 0.5 mg for treatment-naïve patients and entecavir 1 mg for treatment-experienced patients. The recommendation was extended for 6 months in July 2021. In July 2022, the PBAC recommendation was revoked.