Edurant
rilpivirine
Table of contents
Overview
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.
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List item
Edurant : EPAR - Summary for the public (PDF/85.48 KB)
First published: 12/12/2011
Last updated: 16/06/2016
EMA/811100/2011 -
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List item
Edurant : EPAR - Risk-management-plan summary (PDF/93.46 KB)
First published: 04/07/2019
Last updated: 21/10/2019
Authorisation details
Product details | |
---|---|
Name |
Edurant
|
Agency product number |
EMEA/H/C/002264
|
Active substance |
rilpivirine hydrochloride
|
International non-proprietary name (INN) or common name |
rilpivirine
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AG05
|
Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
|
Revision |
20
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Date of issue of marketing authorisation valid throughout the European Union |
28/11/2011
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Contact address |
Turnhoutseweg 30 |
Product information
28/10/2022 Edurant - EMEA/H/C/002264 - IB/0041
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
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.