abacavir / lamivudine

This medicine is authorised for use in the European Union.


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 07/04/2020

Authorisation details

Product details
Agency product number
Active substance
  • abacavir
  • lamivudine
International non-proprietary name (INN) or common name
abacavir / lamivudine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
ViiV Healthcare BV
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Huis ter Heideweg 62
3705 LZ Zeist
The Netherlands

Product information

12/03/2020 Kivexa - EMEA/H/C/000581 - WS/1713


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Pharmacotherapeutic group

  • Antivirals for treatment of HIV infections, combinations
  • Antivirals for systemic use

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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