Tivicay

RSS

dolutegravir

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 17/11/2021

Authorisation details

Product details
Name
Tivicay
Agency product number
EMEA/H/C/002753
Active substance
dolutegravir
International non-proprietary name (INN) or common name
dolutegravir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AX12
Publication details
Marketing-authorisation holder
ViiV Healthcare BV
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
16/01/2014
Contact address

Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands

Product information

23/09/2021 Tivicay - EMEA/H/C/002753 - II/0073/G

Contents

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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

Changes since initial authorisation of medicine

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