Lopinavir/Ritonavir Mylan

lopinavir/ritonavir

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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.

What is Lopinavir/Ritonavir Mylan and what is it used for?

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.

How is Lopinavir/Ritonavir Mylan used?

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.

How does Lopinavir/Ritonavir Mylan work?

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.

How has Lopinavir/Ritonavir Mylan been studied?

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.

What are the benefits and risks of Lopinavir/Ritonavir Mylan?

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.

Why is Lopinavir/Ritonavir Mylan approved?

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.

What measures are being taken to ensure the safe and effective use of Lopinavir/Ritonavir Mylan?

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 summary of the risk management plan.

Other information about Lopinavir/Ritonavir Mylan

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.

Name Language First published Last updated
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public BG = bălgarski 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public ES = español 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public CS = čeština 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public DE = Deutsch 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public ET = eesti keel 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public EL = elliniká 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public FR = français 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public IT = italiano 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public LV = latviešu valoda 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public LT = lietuvių kalba 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public HU = magyar 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public MT = Malti 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public NL = Nederlands 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public PL = polski 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public PT = português 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public RO = română 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public SK = slovenčina 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public SL = slovenščina 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public FI = suomi 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public SV = svenska 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - Summary for the public HR = Hrvatski 2016-02-09  
Name Language First published Last updated
Lopinavir/Ritonavir Mylan : EPAR - Risk-management-plan summary (English only) 2016-02-09  

This EPAR was last updated on 08/07/2016 .

Authorisation details

Product details

Product details for Lopinavir/Ritonavir Mylan
NameLopinavir/Ritonavir Mylan
Agency product numberEMEA/H/C/004025
Active substance

lopinavir/ritonavir

International non-proprietary name (INN) or common name

lopinavir/ritonavir

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR10
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Lopinavir/Ritonavir Mylan
Marketing-authorisation holder

MYLAN S.A.S.

Revision1
Date of issue of marketing authorisation valid throughout the European Union14/01/2016

Contact address:

MYLAN S.A.S.
117 Allée des Parcs 
69800 Saint Priest 
France

Product information

Product information

14/06/2016  Lopinavir/Ritonavir Mylan -EMEA/H/C/004025 -IB/0001

Name Language First published Last updated
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08
Lopinavir/Ritonavir Mylan : EPAR - Product Information EN = English 2016-02-09 2016-07-08

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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


Name Language First published Last updated
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  
Lopinavir/Ritonavir Mylan : EPAR - All Authorised presentations EN = English 2016-02-09  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Lopinavir/Ritonavir Mylan : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-07-08  

Initial marketing-authorisation documents

Name Language First published Last updated
Lopinavir/Ritonavir Mylan : EPAR - Public assessment report EN = English 2016-02-09  
CHMP summary of opinion for Lopinavir / Ritonavir Mylan EN = English 2015-11-20  

Authorised

This medicine is approved for use in the European Union

More information on Lopinavir/Ritonavir Mylan