Darunavir Krka d.d.

Expired

This medicine's authorisation has expired

darunavir

Overview

The marketing authorisation for Darunavir Krka d.d. has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

Darunavir Krka d.d. : EPAR - Summary for the public

Product information

Darunavir Krka d.d. : EPAR - Product Information

Latest procedure affecting product information: IB/0011

22/01/2023

This medicine’s product information is available in all official EU languages.
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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).

Darunavir Krka d.d. : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Darunavir Krka d.d.
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004891
• 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 and hybrid medicines.

• Marketing authorisation holder:
  KRKA, d.d., Novo mesto

  Smarjeska cesta 6 ; 8501 Novo mesto ; Slovenia

• Marketing authorisation issued:
  18/01/2018
• Expiry of marketing authorisation:
  22/01/2023
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Darunavir Krka d.d. : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Darunavir Krka d.d. : EPAR - Public assessment report

AdoptedReference Number: EMA/786962/2017

CHMP summary of positive opinion for Darunavir Krka d.d.

AdoptedReference Number: EMA/CHMP/729969/2017