Prezista

RSS

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 Prezista. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prezista.

This EPAR was last updated on 05/12/2018

Authorisation details

Product details
Name
Prezista
Agency product number
EMEA/H/C/000707
Active substance
darunavir
International non-proprietary name (INN) or common name
darunavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE10
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
44
Date of issue of marketing authorisation valid throughout the European Union
11/02/2007
Contact address
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

20/11/2018 Prezista - EMEA/H/C/000707 - WS/1474/G

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Prezista filLondon (LGW)m-coated tablets 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.

Prezista 75/150/300/600 mg 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 pretreated;
  • for the treatment of HIV‑1 infection in paediatric patients from the age of three years and at least 15 kg body weight.

Prezista 400/800 mg tablets 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.

Prezista 400/800 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 12 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 Prezista in such ART‑experienced patients, genotypic testing should guide the use of Prezista.

Prezista 100-mg/ml oral suspension co‑administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.

Prezista 100-mg/ml oral suspension 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.

In deciding to initiate treatment with Prezista co‑administered with cobicistat or 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 Prezista.

Assessment history

Changes since initial authorisation of medicine

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