Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: EDURANT   
Auth. number : EU/1/11/736
INN : 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 adult patients 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.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-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 continues to be 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 - Variation EMEA/H/C/2264/WS/396 (2013)4026 of 21/06/2013
19/09/2013 Centralised - Variation EMEA/H/C/2264/II/8
18/12/2013 Centralised - Variation EMEA/H/C/2264/II/10
20/03/2014 Centralised - Variation EMEA/H/C/2264/WS/507