lopinavir / ritonavir
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.
Kaletra : EPAR - Summary for the public (PDF/79.59 KB)
First published: 23/09/2009
Last updated: 30/10/2017
Kaletra : EPAR - Risk-management-plan summary (PDF/123.41 KB)
First published: 02/04/2020
Last updated: 29/11/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
AbbVie Deutschland GmbH Co. KG
|Date of issue of marketing authorisation valid throughout the European Union||
31/08/2023 Kaletra - EMEA/H/C/000368 - WS2488
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.
Antivirals for systemic use
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015