Lopinavir/Ritonavir Mylan

RSS

lopinavir/ritonavir

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Lopinavir/Ritonavir Mylan. 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 Lopinavir/Ritonavir Mylan.

For practical information about using Lopinavir/Ritonavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/08/2019

Authorisation details

Product details
Name
Lopinavir/Ritonavir Mylan
Agency product number
EMEA/H/C/004025
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
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
14/01/2016
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

13/08/2019 Lopinavir/Ritonavir Mylan - EMEA/H/C/004025 - IB/0010

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Lopinavir/ritonavir 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 lopinavir/ritonavir 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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