Table of contents
The marketing authorisation for Vitekta has been withdrawn at the request of the marketing-authorisation holder.
Vitekta : EPAR - Summary for the public (PDF/556.37 KB)
First published: 26/11/2013
Last updated: 29/05/2017
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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.
Gilead Sciences International Ltd
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03/11/2016 Vitekta - EMEA/H/C/002577 - WS/0884
This medicine’s product information is available in all official EU languages.
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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.
Antivirals for systemic use
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.