Kaletra

RSS

lopinavir / ritonavir

Authorised
This medicine is authorised for use in the European Union.

Overview

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 05/12/2018

Authorisation details

Product details
Name
Kaletra
Agency product number
EMEA/H/C/000368
Active substance
  • lopinavir
  • ritonavir
International non-proprietary name (INN) or common name
lopinavir / ritonavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR10
Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH Co. KG
Revision
50
Date of issue of marketing authorisation valid throughout the European Union
19/03/2001
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

25/10/2018 Kaletra - EMEA/H/C/000368 - WS/1486

Contents

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.

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

How useful was this page?

Add your rating