Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vitekta   
Auth. number : EU/1/13/883
Active substance : elvitegravir
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: J05AX - Other antivirals
Chemical substance: J05AX11 - Elvitegravir
(See WHO ATC Index)
Indication: In co-administration with a ritonavir-boosted protease inhibitor and with other antiretroviral agent, treatment of HIV-1 infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir
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
14/11/2013 Centralised - Authorisation EMEA/H/C/2577 (2013)8088 of 13/11/2013
20/02/2014 Centralised - Variation EMEA/H/C/2577/WS/484
Updated with Decision(2015)868 of 11/02/2015
20/03/2014 Centralised - Variation EMEA/H/C/2577/WS/530
Updated with Decision(2015)868 of 11/02/2015
13/02/2015 Centralised - Yearly update (2015)868 of 11/02/2015
26/02/2015 Centralised - Variation EMEA/H/C/2577/IG/521