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Questions & Answers

On 22 June 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Kaletra. The marketing authorisation holder for this medicinal product is AbbVie Ltd.

The CHMP adopted an extension to the existing indication as follows1:

“Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years 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 (see sections 4.4 and 5.1).”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1 New text in bold, removed text as strikethrough.

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Kaletra (English only) 2017-06-23  

Key facts

Product details for Kaletra
INN or common name

lopinavir / ritonavir

Therapeutic area HIV Infections
Active substance

lopinavir / ritonavir

Date opinion adopted22/06/2017
Company name

AbbVie Ltd

Application typePost authorisation