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 14/08/2023

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
34
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

20/07/2023 Tivicay - EMEA/H/C/002753 - II/0089

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Product information documents contain:

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

Changes since initial authorisation of medicine

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