Aluvia: Opinion on medicine for use outside EU
lopinavir / ritonavir
Table of contents
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 |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AR10
|
Publication details | |
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Opinion holder |
Knollstrasse |
Date of opinion |
21/09/2006
|
Product information
28/07/2022 Aluvia IB/0116
Contents
- 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
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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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List item
Aluvia : Procedural steps taken and scientific information after opinion (PDF/424.82 KB)
First published: 29/01/2010
Last updated: 15/12/2022 -
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Aluvia : Procedural steps taken before scientific opinion (PDF/24.61 KB)
First published: 29/01/2010 -
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Aluvia : Scientific discussion (PDF/120.23 KB)
First published: 29/01/2010 -
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Aluvia : All presentations (PDF/7.17 KB)
First published: 29/01/2010