🇪🇺 abacavir/lamivudine + darunavir/ritonavir in European Union

EMA authorised abacavir/lamivudine + darunavir/ritonavir on 16 December 2004

Marketing authorisation

EMA — authorised 16 December 2004

  • Application: EMEA/H/C/000581
  • Marketing authorisation holder: ViiV Healthcare BV
  • Local brand name: Kivexa
  • 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.
  • Status: approved

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Other Infectious Diseases approved in European Union

Frequently asked questions

Is abacavir/lamivudine + darunavir/ritonavir approved in European Union?

Yes. EMA authorised it on 16 December 2004.

Who is the marketing authorisation holder for abacavir/lamivudine + darunavir/ritonavir in European Union?

ViiV Healthcare BV holds the EU marketing authorisation.