Juluca
dolutegravir / rilpivirine
Table of contents
Overview
Juluca is a 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.
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List item
Juluca : EPAR - Medicine overview (PDF/147.38 KB)
First published: 24/05/2018
Last updated: 22/04/2020
EMA/134086/2020 -
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List item
Juluca : EPAR - Risk-management-plan summary (PDF/812.6 KB)
First published: 24/05/2018
Last updated: 15/09/2022
Authorisation details
Product details | |
---|---|
Name |
Juluca
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Agency product number |
EMEA/H/C/004427
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AR
|
Publication details | |
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Marketing-authorisation holder |
ViiV Healthcare B.V.
|
Revision |
14
|
Date of issue of marketing authorisation valid throughout the European Union |
16/05/2018
|
Contact address |
Van Asch van Wijckstraat 55 H |
Product information
12/01/2023 Juluca - EMEA/H/C/004427 - R/0049
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
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.