Aluvia: Opinion on medicine for use outside EU

lopinavir / ritonavir

Opinion on medicine for use outside the European Union
Positive opinion

Overview

Aluvia is an antiviral medicine. It is used together with other antiviral medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Aluvia is identical to a medicine already authorised in the European Union (EU) called Kaletra tablets, except for the appearance of the tablets. It has been developed in the context of co-operation with the World Health Organization (WHO) because it can be used against a WHO target disease (HIV/AIDS). It is to be used exclusively in markets outside the EU.

The medicine can only be obtained with a prescription.

Opinion details

Product details
Name of medicinal product
Aluvia
Agency opinion number
H-W-764
Opinion status
Positive opinion
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
Opinion holder

Knollstrasse
67061 Ludwigshafen
Germany

Date of opinion
21/09/2006

Product information

28/07/2022 Aluvia IB/0116

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Aluvia 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.

The choice of Aluvia to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

Assessment history

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