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/66.92 KB)
First published: 02/04/2020
|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||
05/11/2020 Kaletra - EMEA/H/C/000368 - IB/0187
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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