Rukobia

RSS

fostemsavir

Authorised
This medicine is authorised for use in the European Union.

Overview

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 13/04/2021

Authorisation details

Product details
Name
Rukobia
Agency product number
EMEA/H/C/005011
Active substance
fostemsavir trometamol
International non-proprietary name (INN) or common name
fostemsavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AX
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.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
04/02/2021
Contact address

Van Asch van Wijckstraat 55 H
3811 LP Amersfoort
The Netherlands

Product information

10/03/2021 Rukobia - EMEA/H/C/005011 - IB/0002

Contents

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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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