Tivicay

RSS

dolutegravir

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

Overview

This is a summary of the European public assessment report (EPAR) for Tivicay. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tivicay.

For practical information about using Tivicay, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 27/04/2018

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
Additional monitoring

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.

Publication details
Marketing-authorisation holder
ViiV Healthcare
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
16/01/2014
Contact address
80 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Product information

01/03/2018 Tivicay - EMEA/H/C/002753 - II/0031

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Film coated tablet

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 above 6 years of age.

Assessment history

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