Vitekta

RSS

elvitegravir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Vitekta has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 29/05/2017

Authorisation details

Product details
Name
Vitekta
Agency product number
EMEA/H/C/002577
Active substance
elvitegravir
International non-proprietary name (INN) or common name
elvitegravir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AX11
Additional monitoringAdditional monitoring

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

Publication details
Marketing-authorisation holder
Gilead Sciences International Ltd
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
13/11/2013
Contact address
Flowers Building
Granta Park
Abington
Cambridge
CB21 6GT
United Kingdom

Product information

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

Contents

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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

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