Tivicay
dolutegravir
Table of contents
Overview
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.
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List item
Tivicay : EPAR - Medicine overview (PDF/148.41 KB)
First published: 05/02/2014
Last updated: 04/02/2021
EMA/617341/2020 -
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List item
Tivicay : EPAR - Risk-management-plan summary (PDF/640.99 KB)
First published: 04/02/2021
Last updated: 14/09/2022
Authorisation details
Product details | |
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Name |
Tivicay
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Agency product number |
EMEA/H/C/002753
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Active substance |
dolutegravir
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International non-proprietary name (INN) or common name |
dolutegravir
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AX12
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Publication details | |
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Marketing-authorisation holder |
ViiV Healthcare BV
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Revision |
33
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Date of issue of marketing authorisation valid throughout the European Union |
16/01/2014
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Contact address |
Van Asch van Wijckstraat 55H |
Product information
06/03/2023 Tivicay - EMEA/H/C/002753 - IB/0086
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
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.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
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18/05/2018
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16/12/2016
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22/11/2013
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22/11/2013