Darunavir Krka d.d.

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darunavir

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 06/07/2018

Authorisation details

Product details
Name
Darunavir Krka d.d.
Agency product number
EMEA/H/C/004891
Active substance
darunavir
International non-proprietary name (INN) or common name
darunavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE10
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 medicines.

Publication details
Marketing-authorisation holder
KRKA, d.d., Novo mesto
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
18/01/2018
Contact address
Smarjeska cesta 6
8501 Novo mesto
Slovenia

Product information

13/06/2018 Darunavir Krka d.d. - EMEA/H/C/004891 - IB/0001/G

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.

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

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