This is a summary of the European public assessment report (EPAR) for Edurant. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Edurant.
Edurant : EPAR - Summary for the public (PDF/85.48 KB)
First published: 12/12/2011
Last updated: 16/06/2016
Edurant : EPAR - Risk-management-plan summary (PDF/93.46 KB)
First published: 04/07/2019
Last updated: 21/10/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Janssen-Cilag International N.V.
|Date of issue of marketing authorisation valid throughout the European Union||
19/09/2019 Edurant - EMEA/H/C/002264 - II/0035
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Antivirals for systemic use
Edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in antiretroviral treatment‑naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV‑1 RNA copies/ml.
As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Edurant.