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 09/06/2022

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 Pharmaceuticals Limited
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
14/01/2016
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Product information

09/06/2022 Lopinavir/Ritonavir Mylan - EMEA/H/C/004025 - IA/0022

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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