Ziagen

RSS

abacavir

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

Overview

This is a summary of the European Public Assessment Report (EPAR) for Ziagen. 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 Ziagen.

This EPAR was last updated on 19/04/2018

Authorisation details

Product details
Name
Ziagen
Agency product number
EMEA/H/C/000252
Active substance
abacavir
International non-proprietary name (INN) or common name
abacavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AF06
Publication details
Marketing-authorisation holder
ViiV Healthcare UK Limited
Revision
35
Date of issue of marketing authorisation valid throughout the European Union
07/07/1999
Contact address
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Product information

01/03/2018 Ziagen - EMEA/H/C/000252 - II/0101/G

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 systemic use

Therapeutic indication

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children.

The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy.

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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