lopinavir / ritonavir

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Kaletra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kaletra.

For practical information about using Kaletra, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 19/10/2023

Authorisation details

Product details
Agency product number
Active substance
  • lopinavir
  • ritonavir
International non-proprietary name (INN) or common name
  • lopinavir
  • ritonavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH Co. KG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

67061 Ludwigshafen

Product information

31/08/2023 Kaletra - EMEA/H/C/000368 - WS2488

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Product information documents contain:

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

  • Protease inhibitors

Therapeutic indication

Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.

The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

Assessment history

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