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.

Lopinavir/Ritonavir Mylan is used in combination with other 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). Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir.

Lopinavir/Ritonavir Mylan is a ‘generic medicine’. This means that it is similar to a ‘reference medicine’ already authorised in the European Union (EU), called Kaletra.

Lopinavir/Ritonavir Mylan can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection. It is available as tablets (100 mg lopinavir and 25 mg ritonavir; 200 mg lopinavir and 50 mg ritonavir).

In adults and adolescents (aged 12 years and over), the recommended dose of Lopinavir/Ritonavir Mylan is two 200/50-mg tablets twice a day. This dose is also suitable for children (aged between two and 12 years) provided that they weigh more than 40 kg or have a body surface area (calculated using the child’s height and weight) over 1.4 m2. The dose for smaller children depends on the child’s body surface area and the other medicines that the child is taking.

For adults (aged 18 years or over) who are infected with HIV that is likely to respond to medicines in the same class as Lopinavir/Ritonavir Mylan (protease inhibitors) the doctor may prescribe the full daily dose of four 200/50-mg tablets as a single dose. When deciding to use once-daily dosing, the doctor should consider the fact that it might not be as effective as twice-daily dosing at keeping HIV levels low in the long term and may increase the risk of diarrhoea. For more information, see the package leaflet.

The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV. When the enzyme is blocked, the virus does not replicate normally, slowing down the spread of infection. In Lopinavir/Ritonavir Mylan, lopinavir provides the activity and ritonavir is used as a ‘booster’ that slows down the rate at which lopinavir is broken down by the liver. This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.

Lopinavir/Ritonavir Mylan, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level. It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.

Because Lopinavir/Ritonavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Kaletra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

Because Lopinavir/Ritonavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Lopinavir/Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Kaletra. Therefore, the CHMP’s view was that, as for Kaletra, the benefit outweighs the identified risk. The Committee recommended that Lopinavir/Ritonavir Mylan be approved for use in the EU.

A risk management plan has been developed to ensure that Lopinavir/Ritonavir Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lopinavir/Ritonavir Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the Lopinavir/Ritonavir Mylan : EPAR - Risk-management-plan summary.

The European Commission granted a marketing authorisation valid throughout the European Union for Lopinavir/Ritonavir Mylan on 14 January 2016.

For more information about treatment with Lopinavir/Ritonavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Lopinavir/Ritonavir Mylan : EPAR - Summary for the public

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Lopinavir/Ritonavir Mylan : EPAR - Risk-management-plan summary

Product information

Lopinavir/Ritonavir Mylan : EPAR - Product Information

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Latest procedure affecting product information: IB/0027

16/01/2024

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This medicine’s product information is available in all official EU languages.
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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations

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Product details

Name of medicine
Lopinavir/Ritonavir Mylan
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

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.

Authorisation details

EMA product number
EMEA/H/C/004025

Generic

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.

Marketing authorisation holder
Mylan Pharmaceuticals Limited

Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Opinion adopted
19/11/2015
Marketing authorisation issued
14/01/2016
Revision
17

Assessment history

Lopinavir/Ritonavir Mylan : EPAR - Procedural steps taken and scientific information after authorisation

Lopinavir/Ritonavir Mylan : EPAR - Public assessment report

CHMP summary of opinion for Lopinavir / Ritonavir Mylan

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