This medicine is authorised for use in the European Union.


Rukobia is a medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Rukobia is given with other HIV medicines when none of the standard combinations work well enough to control the infection because the virus is resistant to them (multi-drug resistant HIV-1).

This EPAR was last updated on 11/10/2023

Authorisation details

Product details
Agency product number
Active substance
fostemsavir trometamol
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
ViiV Healthcare B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Van Asch van Wijckstraat 55 H
3811 LP Amersfoort
The Netherlands

Product information

14/09/2023 Rukobia - EMEA/H/C/005011 - II/0011

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

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.

Assessment history

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