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The marketing authorisation for Vitekta has been withdrawn at the request of the marketing-authorisation holder.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 |
Flowers Building
Granta Park Abington Cambridge CB21 6GT United Kingdom |
Product information
03/11/2016 Vitekta - EMEA/H/C/002577 - WS/0884
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.