Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Eviplera   
Auth. number : EU/1/11/737
INN : emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)
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: J05AR - Antivirals for treatment of hiv infections, combinations
Chemical substance: J05AR08 - Emtricitabine, rilpivirine and tenofovir disoproxil
(See WHO ATC Index)
Indication: Eviplera 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 Eviplera.
Marketing Authorisation Holder: Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom

  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
28/11/2011 Centralised - Authorisation EMEA/H/C/2312 (2011)8956 of 28/11/2011
26/10/2012 Centralised - Variation EMEA/H/C/2312/II/6, 12 (2012)7676 of 24/10/2012
15/11/2012 Centralised - Variation EMEA/H/C/2312/II/14
Updated with Decision(2013)4027 of 21/06/2013
13/12/2012 Centralised - Variation EMEA/H/C/2312/II/15
Updated with Decision(2013)4027 of 21/06/2013
17/01/2013 Centralised - Variation EMEA/H/C/2312/II/17
Updated with Decision(2013)4027 of 21/06/2013
21/02/2013 Centralised - Variation EMEA/H/C/2312/II/20
Updated with Decision(2013)4027 of 21/06/2013
25/06/2013 Centralised - 2-Monthly update EMEA/H/C/2312/IB/WS/391 (2013)4027 of 21/06/2013
19/09/2013 Centralised - Variation EMEA/H/C/2312/II/27
Updated with Decision(2013)8706 of 29/11/2013
04/12/2013 Centralised - 2-Monthly update EMEA/H/C/2312/II/21 (2013)8706 of 29/11/2013
18/12/2013 Centralised - Variation EMEA/H/C/2312/II/30
20/03/2014 Centralised - Variation EMEA/H/C/2312/WS/530
23/06/2014 Centralised - Variation EMEA/H/C/2312/II/39
24/07/2014 Centralised - Variation EMEA/H/C/2312/WS/575
24/07/2014 Centralised - Variation EMEA/H/C/2312/WS/586
03/09/2014 Centralised - Variation EMEA/H/C/2312/IB/49