Regulatory PathRegulatory requirements compared

Active substance

Fostemsavir

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
RUKOBIAEQ 600MG BASEtablet, extended release · oralVIIV HLTHCAREPrescription2 Jul 2020

EMA European Union — centrally authorised medicines

Rukobia ViiV Healthcare B.V. · Authorised · authorised 4 Feb 2021 · ATC J05AX

Therapeutic indication (EMA)

Rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
RUKOBIA02520869600 MGTABLET (EXTENDED-RELEASE) · ORALVIIV HEALTHCARE ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACRUKOBIA ER 600 MG TABLET$156.83623per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for fostemsavir →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.