Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Stribild   
Auth. number : EU/1/13/830
INN : elvitegravir / cobicistat / emtricitabine / 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: J05AR09 - Emtricitabine, tenofovir disoproxil, elvitegravir and cobicistat
(See WHO ATC Index)
Indication: Stribild is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV 1 without known mutations associated with resistance to the three antiretroviral agents in Stribild (see section 4.2, 4.4 and 5.1)
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
27/05/2013 Centralised - Authorisation EMEA/H/C/2574 (2013)3210 of 24/05/2013
19/09/2013 Centralised - Variation EMEA/H/C/2574/II/6
Updated with Decision(2014)6467 of 09/09/2014
20/02/2014 Centralised - Variation EMEA/H/C/2574/II/19
Updated with Decision(2014)6467 of 09/09/2014
20/02/2014 Centralised - Variation EMEA/H/C/2574/WS/484
Updated with Decision(2014)6467 of 09/09/2014
20/03/2014 Centralised - Variation EMEA/H/C/2574/WS/530
Updated with Decision(2014)6467 of 09/09/2014
27/03/2014 Centralised - Variation EMEA/H/C/2574/IB/24
Updated with Decision(2014)6467 of 09/09/2014
22/05/2014 Centralised - Variation EMEA/H/C/2574/II/25
Updated with Decision(2014)6467 of 09/09/2014
24/07/2014 Centralised - Variation EMEA/H/C/2574/IB/WS/575
Updated with Decision(2014)6467 of 09/09/2014
24/07/2014 Centralised - Variation EMEA/H/C/2574/II/WS/586
Updated with Decision(2014)6467 of 09/09/2014
10/09/2014 Centralised - Yearly update (2014)6467 of 09/09/2014