Juluca

RSS

dolutegravir / rilpivirine

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

Overview

An overview of Juluca and why it is authorised in the EU

Juluca is a HIV medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Juluca is only used for patients whose levels of HIV-1 in the blood (viral load) have been below 50 copies/ml for at least 6 months on their current HIV treatment combination. It is not suitable for patients in whom any HIV medicine has stopped working or who are infected with HIV that is resistant to medicines that work in the same way as Juluca's active substances.

The active substances in Juluca are dolutegravir and rilpivirine.

This EPAR was last updated on 24/05/2018

Authorisation details

Product details
Name
Juluca
Agency product number
EMEA/H/C/004427
Active substance
 dolutegravir sodium,rilpivirine hydrochloride
International non-proprietary name (INN) or common name
dolutegravir / rilpivirine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR
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
Marketing-authorisation holder
ViiV Healthcare UK Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
16/05/2018
Contact address
980 Great West Road
Brentford TW8 9GS
United Kingdom

Product information

16/05/2018 Juluca - EMEA/H/C/004427 - -

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.

Assessment history

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