Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: EDURANT   
Auth. number : EU/1/11/736
Active substance : rilpivirine
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AG - Non-nucleoside reverse transcriptase inhibitors
Chemical substance: J05AG05 - rilpivirine
(See WHO ATC Index)
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.

Genotypic resistance testing should guide the use of EDURANT
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/11/2011 Centralised - Authorisation EMEA/H/C/2264 (2011)8955 of 28/11/2011
26/10/2012 Centralised - Variation EMEA/H/C/2264/II/1/G, EMEA/H/C/2264/II/2, 3 (2012)7678 of 24/10/2012
13/12/2012 Centralised - Variation EMEA/H/C/2264/II/5
Updated with Decision(2013)4026 of 21/06/2013
21/02/2013 Centralised - Variation EMEA/H/C/2264/II/6
Updated with Decision(2013)4026 of 21/06/2013
25/06/2013 Centralised - 2-Monthly update EMEA/H/C/2264/WS/396 (2013)4026 of 21/06/2013
19/09/2013 Centralised - Variation EMEA/H/C/2264/II/8
Updated with Decision(2014)6258 of 01/09/2014
18/12/2013 Centralised - Variation EMEA/H/C/2264/II/10
Updated with Decision(2014)6258 of 01/09/2014
20/03/2014 Centralised - Variation EMEA/H/C/2264/WS/507
Updated with Decision(2014)6258 of 01/09/2014
03/09/2014 Centralised - Yearly update (2014)6258 of 01/09/2014
24/11/2015 Centralised - 2-Monthly update EMEA/H/C/2264/II/17/G (2015)8366 of 20/11/2015
28/01/2016 Centralised - Variation EMEA/H/C/2264/WS/872
Updated with Decision(2016)4916 of 22/07/2016
22/04/2016 Centralised - Notification EMEA/H/C/2264/N/23
Updated with Decision(2016)4916 of 22/07/2016
26/07/2016 Centralised - Renewal EMEA/H/C/2264/R/22 (2016)4916 of 22/07/2016
06/07/2017 Centralised - Variation EMEA/H/C/2264/II/25
Updated with Decision(2017)5942 of 24/08/2017
28/08/2017 Centralised - 2-Monthly update EMEA/H/C/2264/II/24 (2017)5942 of 24/08/2017
19/02/2018 Centralised - Notification EMEA/H/C/2264/N/27
11/04/2018 Centralised - Notification EMEA/H/C/2264/N/29