Prezista

RSS

darunavir

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

Overview

Prezista is used together with low-dose ritonavir and other HIV medicines to treat patients from 3 years of age (weighing at least 15 kg) who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

In adults and adolescents (12 years of age or more and weighing at least 40 kg), Prezista is also used with another medicine, cobicistat, in combination with other HIV medicines to treat HIV-1 infection.

Prezista contains the active substance darunavir.

This EPAR was last updated on 13/10/2020

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
50
Date of issue of marketing authorisation valid throughout the European Union
11/02/2007
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

03/09/2020 Prezista - EMEA/H/C/000707 - WS/1883

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

PREZISTA, 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, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).

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.

PREZISTA, 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 mg, 150 mg, and 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 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 PREZISTA 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 PREZISTA.

PREZISTA, 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, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).

PREZISTA 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.
  • 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.

Assessment history

Changes since initial authorisation of medicine

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