Darunavir Krka | European Medicines Agency (EMA)

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Overview

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

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

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

Darunavir Krka contains the active substance darunavir.

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

Darunavir Krka 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 is available as tablets. The medicine is always taken with low-dose ritonavir and with other HIV medicines, and should be taken with food.

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

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.

As for every medicine, the company provided studies on the quality of Darunavir Krka. 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.

Because Darunavir Krka 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 European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka 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 be approved for use in the EU.

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

The European Commission granted a marketing authorisation valid throughout the European Union for Darunavir Krka on 26 January 2018.

For more information about treatment with Darunavir Krka, 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.

English (EN)
(92.54 KB – PDF)

First published: 06/02/2018Last updated: 06/02/2018

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Product information

English (EN)
(608.62 KB – PDF)

First published: 06/02/2018Last updated: 28/01/2025

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Latest procedure affecting product information:
N/0000241954

17/01/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

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).

English (EN)
(11.14 KB – PDF)

First published: 06/02/2018Last updated: 06/02/2018

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Product details

Name of medicine: Darunavir Krka
Active substance: darunavir
International non-proprietary name (INN) or common name: darunavir
Therapeutic area (MeSH): HIV Infections
Anatomical therapeutic chemical (ATC) code: J05AE10

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

400 and 800 mg

Darunavir Krka, 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 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).

600 mg

Darunavir Krka 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.

More information on Darunavir Krka

English (EN)
(66.45 KB – PDF)

First published: 09/07/2007Last updated: 07/12/2012

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