Tivicay is a medicine used together with other medicines to treat adults and children from 4 weeks of age and weighing at least 3 kg who are infected with human immunodeficiency virus (HIV), a virus that causes acquired immune deficiency syndrome (AIDS).
Tivicay contains the active substance dolutegravir.
Tivicay : EPAR - Medicine overview (PDF/148.41 KB)
First published: 05/02/2014
Last updated: 04/02/2021
Tivicay : EPAR - Risk-management-plan summary (PDF/640.99 KB)
First published: 04/02/2021
Last updated: 14/09/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
ViiV Healthcare BV
|Date of issue of marketing authorisation valid throughout the European Union||
Van Asch van Wijckstraat 55H
22/09/2022 Tivicay - EMEA/H/C/002753 - WS2334
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.
Antivirals for systemic use
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg.
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 201616/12/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013