Ziagen

RSS

abacavir

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

Overview

Ziagen is used with other antiviral medicines to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).

Ziagen contains the active substance abacavir.

This EPAR was last updated on 28/07/2020

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 B.V.
Revision
41
Date of issue of marketing authorisation valid throughout the European Union
08/07/1999
Contact address

Van Asch van Wijckstraat 55 H
3811 LP Amersfoort
The Netherlands

Product information

11/06/2020 Ziagen - EMEA/H/C/000252 - WS/1713

Contents

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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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