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EMA Approval

Kaletra

J05AR10

lopinavir and ritonavir

lopinavirritonavir

HIV Infections

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeJ05AR10
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

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.

Authorisations (1)

EMEA/H/C/000368

AbbVie Deutschland GmbH Co. KG,Knollstrasse,67061 Ludwigshafen,Germany

Authorised

March 19, 2001

Active Substances (2)

lopinavir

ritonavir

Documents (15)

Kaletra : EPAR - Summary for the public

September 22, 2009

OVERVIEW_DOCUMENT

Kaletra : EPAR - Scientific Discussion

August 8, 2006

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Kaletra : EPAR - Procedural steps taken before authorisation

August 8, 2006

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Kaletra : EPAR - Procedural steps taken and scientific information after authorisation (archive)

September 22, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Kaletra : EPAR - Procedural steps taken before authorisation

August 8, 2006

CHANGES_SINCE_INITIAL_AUTHORISATION

Kaletra-H-C-368-X-0027 : EPAR - Scientific Discussion - Extension

September 22, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Kaletra : EPAR - Risk-management-plan summary

April 2, 2020

RISK_MANAGEMENT_PLAN_SUMMARY

Kaletra : EPAR - All Authorised presentations

September 22, 2009

AUTHORISED_PRESENTATIONS

Kaletra-H-C-368-II-0161-G : EPAR - Assessment Report - Variation

October 29, 2017

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP post-authorisation summary of positive opinion for Kaletra

June 22, 2017

CHANGES_SINCE_INITIAL_AUTHORISATION

Kaletra-H-C-368-P45-0099 : EPAR - Assessment Report

August 19, 2013

CHANGES_SINCE_INITIAL_AUTHORISATION

Kaletra : EPAR - Procedural steps taken and scientific information after authorisation

April 10, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Kaletra : EPAR - Scientific Discussion

August 8, 2006

CHANGES_SINCE_INITIAL_AUTHORISATION

Kaletra : EPAR - Product Information

September 22, 2009

DRUG_PRODUCT_INFORMATION

Kaletra : EPAR - Steps taken after authorisation when a cutoff date has been used

August 8, 2006

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (8)

Question

Other information about Kaletra

Answer

The European Commission granted a marketing authorisation valid throughout the European Union for Kaletra on 20 March 2001.

For more information about treatment with Kaletra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Question

How is Kaletra used?

Answer

Kaletra is available as tablets, capsules and oral liquid. The capsules and liquid must be taken with food, but the tablets can be taken with or without food.

The medicine is taken once or twice daily in adults, and the dose depends on the type of virus the patient is infected with. In children, the dose depends on body weight and height.

Kaletra can only be obtained with a prescription and should be prescribed by a doctor with experience treating HIV infection. For further information, see the package leaflet.

Question

How does Kaletra work?

Answer

Both active substances in Kaletra are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally slowing down its multiplication in the body. In Kaletra, lopinavir provides the activity against the virus while ritonavir mainly works as a ‘booster’ to slow down the rate at which lopinavir is broken down by the liver. Kaletra does not cure HIV infection or AIDS, but it may hold off damage to the immune system, and the development of infections and diseases associated with AIDS.

Question

What benefits of Kaletra have been shown in studies?

Answer

Studies have shown that Kaletra is effective at reducing viral load (the amount of virus found in the blood) to very low levels (below 400 copies/ml).

In one study of adults who had not been treated for HIV before, 79% of the patients taking Kaletra (259 out of 326) had very low levels of the virus after 24 weeks, compared with 71% of the patients taking nelfinavir (233 out of 327).

A second adult study in patients who had previously taken a protease inhibitor, 73% of the patients taking Kaletra (43 out of 59) had very low levels of the virus after 16 weeks, compared with 54% of the patients taking the comparator medicines (32 out of 59).

Studies in children from 14 days of age showed between 71% and 85% of patients having very low levels of the virus after 48 weeks of treatment with Kaletra.

Question

What are the risks associated with Kaletra?

Answer

The most common side effects with Kaletra in adults (seen in more than 1 patient in 10) are upper respiratory tract infection (colds), nausea (feeling sick) and diarrhoea. Side effects are similar in children. For the full list of all side effects reported with Kaletra, see the package leaflet.

Kaletra must not be used by patients with severe liver disease or by patients who are taking St John’s wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Kaletra and are harmful at high levels in the blood. For the full list of restrictions, see the package leaflet.

Question

Why is Kaletra approved?

Answer

Kaletra is effective at reducing HIV viral loads to below 400 copies/ml in the majority of adults and children from 14 days of age. The medicine is also well tolerated and its side effects are manageable. The European Medicines Agency (EMA) therefore concluded that the benefits of Kaletra outweigh its risks and recommended that it be given marketing authorisation in the EU.

Question

What measures are being taken to ensure the safe and effective use of Kaletra?

Answer

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kaletra have been included in the summary of product characteristics and the package leaflet.

Question

What is Kaletra and what is it used for?

Answer

Kaletra is an HIV medicine used in combination with other medicines to treat adults and children from over 14 days of age who are infected with HIV?1. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Kaletra contains two active substances, lopinavir and ritonavir.

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