Vitekta

elvitegravir

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The marketing authorisation for Vitekta has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Vitekta : EPAR - Summary for the public BG = bălgarski 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public ES = español 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public CS = čeština 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public DA = dansk 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public DE = Deutsch 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public ET = eesti keel 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public EL = elliniká 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public EN = English 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public FR = français 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public IT = italiano 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public LV = latviešu valoda 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public LT = lietuvių kalba 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public HU = magyar 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public MT = Malti 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public NL = Nederlands 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public PL = polski 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public PT = português 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public RO = română 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public SK = slovenčina 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public SL = slovenščina 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public FI = suomi 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public SV = svenska 2013-11-26 2017-05-29
Vitekta : EPAR - Summary for the public HR = Hrvatski 2013-11-26 2017-05-29

This EPAR was last updated on 29/05/2017 .

Authorisation details

Product details

Product details for Vitekta
NameVitekta
Agency product numberEMEA/H/C/002577
Active substance

elvitegravir

International non-proprietary name (INN) or common name

elvitegravir

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AX11
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Vitekta
Marketing-authorisation holder

Gilead Sciences International Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union13/11/2013

Contact address:

Gilead Sciences International Ltd
Flowers Building
Granta Park
Abington
Cambridge
CB21 6GT
United Kingdom

Product information

Product information

03/11/2016  Vitekta -EMEA/H/C/002577 -WS/0884

Name Language First published Last updated
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - Product Information HR = Hrvatski 2013-11-26 2017-05-29

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29
Vitekta : EPAR - All Authorised presentations HR = Hrvatski 2013-11-26 2017-05-29

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vitekta : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-05-15 2017-05-29
Vitekta-H-C-2577-P46-013 : EPAR - Assessment Report - Variation HR = Hrvatski 2016-01-22 2017-05-29

Initial marketing-authorisation documents

Name Language First published Last updated
Vitekta : EPAR - Public assessment report HR = Hrvatski 2013-11-26 2017-05-29
CHMP summary of positive opinion for Vitekta HR = Hrvatski 2013-09-20 2017-05-29

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Vitekta