Kaletra
lopinavir / ritonavir
Table of contents
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.
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List item
Kaletra : EPAR - Summary for the public (PDF/79.59 KB)
First published: 23/09/2009
Last updated: 30/10/2017 -
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List item
Kaletra : EPAR - Risk-management-plan summary (PDF/66.92 KB)
First published: 02/04/2020
Authorisation details
Product details | |
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Name |
Kaletra
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Agency product number |
EMEA/H/C/000368
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AR10
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Publication details | |
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Marketing-authorisation holder |
AbbVie Deutschland GmbH Co. KG
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Revision |
55
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Date of issue of marketing authorisation valid throughout the European Union |
19/03/2001
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Contact address |
Product information
05/11/2020 Kaletra - EMEA/H/C/000368 - IB/0187
Contents
- 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.
Pharmacotherapeutic group
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Antivirals for systemic use
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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
News
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23/06/2017
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015
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23/10/2015