Reyataz

RSS

atazanavir sulphate

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

Overview

This document is a summary of the European Public Assessment Report (EPAR) for Reyataz. 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 Reyataz.

This EPAR was last updated on 04/10/2019

Authorisation details

Product details
Name
Reyataz
Agency product number
EMEA/H/C/000494
Active substance
atazanavir sulphate
International non-proprietary name (INN) or common name
atazanavir sulphate
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE08
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
49
Date of issue of marketing authorisation valid throughout the European Union
01/03/2004
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Product information

13/03/2019 Reyataz - EMEA/H/C/000494 - IG/1059

Contents

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

Reyataz capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).

Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations).

The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).

Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).

Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors ( 4 PI mutations). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).

Assessment history

Changes since initial authorisation of medicine

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