Rukobia
fostemsavir
Table of contents
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).
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Rukobia : EPAR - Medicine overview (PDF/122.16 KB)
First published: 12/02/2021
EMA/707937/2020 -
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Rukobia : EPAR - Risk-management-plan summary (PDF/204.77 KB)
First published: 12/02/2021
Authorisation details
Product details | |
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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 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 | |
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Marketing-authorisation holder |
ViiV Healthcare B.V.
|
Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
04/02/2021
|
Contact address |
Van Asch van Wijckstraat 55 H |
Product information
14/09/2023 Rukobia - EMEA/H/C/005011 - II/0011
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.