Darunavir Krka d.d.

darunavir

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

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

What is Darunavir Krka d.d. and what is it used for?

Darunavir Krka d.d. 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 Krka d.d. may be given to adults or children from 3 years of age and weighing at least 15 kg.

Darunavir Krka d.d. contains the active substance darunavir.

Darunavir Krka d.d. is a ‘generic medicine’. This means that Darunavir Krka d.d. 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 Krka d.d. used?

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

Darunavir Krka d.d. is available as tablets. The medicine is to be taken with low-dose ritonavir or, as an alternative in adults, with cobicistat and with other HIV medicines, and should be taken with food.

How does Darunavir Krka d.d. work?

The active substance in Darunavir Krka d.d., 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 Krka d.d. is always given with ritonavir. Ritonavir reduces the breakdown of darunavir, increasing the levels of darunavir in the blood. This allows effective treatment while avoiding a higher dose of darunavir.

Darunavir Krka d.d., taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Darunavir Krka d.d. 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 Krka d.d. 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 Krka d.d.

As for every medicine, the company provided studies on the quality of Darunavir Krka d.d. The company also carried out a study 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 Krka d.d.?

Because Darunavir Krka d.d. 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 Krka d.d. approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka d.d. has been shown to have comparable quality and to be bioequivalent to Prezista. Therefore, the Agency’s view was that, as for Prezista, the benefit outweighs the identified risk. The Agency recommended that Darunavir Krka d.d. be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Darunavir Krka d.d.?

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

Other information about Darunavir Krka d.d.

The European Commission granted a marketing authorisation valid throughout the European Union for Darunavir Krka d.d. on 18 January 2018.

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

The full EPAR for the reference medicine can also be found on the Agency’s website.

Name Language First published Last updated
Darunavir Krka d.d. : EPAR - Summary for the public BG = bălgarski 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public ES = español 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public CS = čeština 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public DA = dansk 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public DE = Deutsch 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public ET = eesti keel 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public EL = elliniká 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public EN = English 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public FR = français 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public IT = italiano 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public LV = latviešu valoda 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public LT = lietuvių kalba 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public HU = magyar 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public MT = Malti 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public NL = Nederlands 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public PL = polski 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public PT = português 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public RO = română 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public SK = slovenčina 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public SL = slovenščina 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public FI = suomi 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public SV = svenska 2018-01-25  
Darunavir Krka d.d. : EPAR - Summary for the public HR = Hrvatski 2018-01-25  

This EPAR was last updated on 25/01/2018 .

Authorisation details

Product details

Product details for Darunavir Krka d.d.
NameDarunavir Krka d.d.
Agency product numberEMEA/H/C/004891
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 Krka d.d.
Marketing-authorisation holder

KRKA, d.d., Novo mesto

Revision0
Date of issue of marketing authorisation valid throughout the European Union18/01/2018

Contact address:

KRKA, d.d., Novo mesto
Smarjeska cesta 6 
8501 Novo mesto 
Slovenia
 

Product information

Product information

18/01/2018  Darunavir Krka d.d. -EMEA/H/C/004891 --

Name Language First published Last updated
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - Product Information HR = Hrvatski 2018-01-25  

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 Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  
Darunavir Krka d.d. : EPAR - All Authorised presentations HR = Hrvatski 2018-01-25  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

400mg and 800 mg Film-coated Tablets

Darunavir Krka d.d., 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 Krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).

Darunavir Krka d.d. 400 mg and 800 mg 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 (see section 4.2).
  • 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 (see sections 4.2, 4.3, 4.4 and 5.1). 

600mg Film-coated Tablets

Darunavir Krka d.d., 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 Krka d.d. 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):

  • 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 darunavir.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Darunavir Krka d.d. : EPAR - Public assessment report HR = Hrvatski 2018-01-25  
CHMP summary of positive opinion for Darunavir Krka d.d. HR = Hrvatski 2017-11-10  

Authorised

This medicine is approved for use in the European Union

More information on Darunavir Krka d.d.