Vitekta
elvitegravir
Table of contents
Overview
The marketing authorisation for Vitekta has been withdrawn at the request of the marketing-authorisation holder.
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 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 | |
Product information
03/11/2016 Vitekta - EMEA/H/C/002577 - WS/0884
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
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You are therefore advised to be selective about which sections or pages you wish to print.
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.