Aluvia - opinion on medicine for use outside EU

lopinavir / ritonavir

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.

Aluvia : Medicine overview

Reference Number: EMA/163129/2010

Product information

Aluvia : Product information

Latest procedure affecting product information: IAIN/0120

17/11/2023

Product information documents contain:

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturer responsible for batch release
• Annex IIB - Recommendations to the opinion holder - conditions of use
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Aluvia : All presentations

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.

Opinion details

Product details

• Name of medicine:
  Aluvia
• EMA 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:
  AbbVie Deutschland GmbH & Co. KG

  Knollstrasse; 67061 Ludwigshafen; Germany

• Date of opinion:
  21/09/2006

Assessment history

Aluvia : Procedural steps taken and scientific information after opinion

Aluvia : Procedural steps taken before scientific opinion

Aluvia : Scientific discussion