Darunavir Mylan

darunavir

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

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

What is Darunavir Mylan and what is it used for?

Darunavir Mylan is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is given with low-dose ritonavir or, in adults, with cobicistat. Darunavir Mylan may be given to adults or children from 3 years of age and weighing at least 15 kg.

Darunavir Mylan contains the active substance darunavir.

Darunavir Mylan is a ‘generic medicine’. This means that Darunavir Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Prezista.

How is Darunavir Mylan used?

Darunavir Mylan can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV infection.

Darunavir Mylan is available as tablets (75, 150, 300, 400, 600 and 800 mg). The medicine is always taken either with cobicistat (in adults) or with low-dose ritonavir (in adults and children) and with other HIV medicines, and should be taken with food.

For adults who have not been treated before, the recommended dose is 800 mg once a day. For adults who have been treated before, the dose is 600 mg twice a day. Previously treated patients can also take a dose of 800 mg once a day provided that their HIV infection is well controlled and is not likely to be resistant to darunavir.

For children aged 3 to 17 years and weighing at least 15 kg who have not be treated before, the recommended dose varies between 600 and 800 mg once daily depending on their weight. For previously treated children the usually recommended dose varies between 375 and 600 mg twice a day depending on their weight.

For further information, see the package leaflet.

How does Darunavir Mylan work?

The active substance in Darunavir Mylan, darunavir, is a protease inhibitor. It blocks protease, an enzyme involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body. Darunavir Mylan is always given with ritonavir or cobicistat. Ritonavir and cobicistat reduce the breakdown of darunavir, increasing the levels of darunavir in the blood. This allows effective treatment while avoiding a higher dose of darunavir.

Darunavir Mylan, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Darunavir Mylan does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Darunavir Mylan been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Mylan.

As for every medicine, the company provided studies on the quality of Darunavir Mylan. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Darunavir Mylan?

Because Darunavir 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 Darunavir Mylan approved?

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

What measures are being taken to ensure the safe and effective use of Darunavir Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Mylan have been included in the summary of product characteristics and the package leaflet.

Other information about Darunavir Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Darunavir Mylan on 04 January 2017.

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

Name Language First published Last updated
Darunavir Mylan : EPAR - Summary for the public BG = bălgarski 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public ES = español 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public CS = čeština 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public DA = dansk 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public DE = Deutsch 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public ET = eesti keel 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public EL = elliniká 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public EN = English 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public FR = français 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public IT = italiano 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public LV = latviešu valoda 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public LT = lietuvių kalba 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public HU = magyar 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public MT = Malti 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public NL = Nederlands 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public PL = polski 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public PT = português 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public RO = română 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public SK = slovenčina 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public SL = slovenščina 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public FI = suomi 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public SV = svenska 2017-02-03  
Darunavir Mylan : EPAR - Summary for the public HR = Hrvatski 2017-02-03  

This EPAR was last updated on 05/07/2017 .

Authorisation details

Product details

Product details for Darunavir Mylan
NameDarunavir Mylan
Agency product numberEMEA/H/C/004068
Active substance

darunavir

International non-proprietary name (INN) or common name

darunavir

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AE10
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 Darunavir Mylan
Marketing-authorisation holder

Mylan S.A.S.

Revision1
Date of issue of marketing authorisation valid throughout the European Union04/01/2017

Contact address:

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

Product information

Product information

07/06/2017  Darunavir Mylan -EMEA/H/C/004068 -IB/0002/G

Name Language First published Last updated
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05
Darunavir Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03 2017-07-05

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
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Darunavir Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.

Darunavir Mylan tablets may be used to provide suitable dose regimens:

  • For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
  • For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.

In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of daranuvir.

Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.

Darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.

Darunavir Mylan tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:

  • antiretroviral therapy (ART)-naïve.
  • ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Darunavir Mylan : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-07-05  

Initial marketing-authorisation documents

Name Language First published Last updated
Darunavir Mylan : EPAR - Public assessment report HR = Hrvatski 2017-02-03  
CHMP summary of positive opinion for Darunavir Mylan HR = Hrvatski 2016-11-11  

Authorised

This medicine is approved for use in the European Union

More information on Darunavir Mylan