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.
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 |
47
|
Date of issue of marketing authorisation valid throughout the European Union |
08/07/1999
|
Contact address |
Van Asch van Wijckstraat 55 H |
Product information
27/09/2023 Ziagen - EMEA/H/C/000252 - IB/0126
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.