Kivexa

RSS

abacavir / lamivudine

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

Overview

This is a summary of the European public assessment report (EPAR) for Kivexa. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Kivexa.

This EPAR was last updated on 21/02/2018

Authorisation details

Product details
Name
Kivexa
Agency product number
EMEA/H/C/000581
Active substance
  • abacavir
  • lamivudine
International non-proprietary name (INN) or common name
abacavir / lamivudine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR02
Publication details
Marketing-authorisation holder
ViiV Healthcare UK Limited 
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
16/12/2004
Contact address
ViiV Healthcare UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Product information

24/01/2018 Kivexa - EMEA/H/C/000581 - WS/1156

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

  • Antivirals for treatment of HIV infections
  • combinations

Therapeutic indication

Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.

Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Assessment history

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