Atazanavir Krka

RSS

atazanavir

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

Overview

 

Atazanavir Krka is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS). It is used together with low-dose ritonavir and other antiviral medicines to treat patients aged 6 years and over.

Doctors should prescribe Atazanavir Krka only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Krka. The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Krka (protease inhibitors) do not work.

Atazanavir Krka contains the active substance atazanavir and is a ‘generic medicine’. This means that Atazanavir Krka contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Reyataz.

This EPAR was last updated on 15/05/2019

Authorisation details

Product details
Name
Atazanavir Krka
Agency product number
EMEA/H/C/004859
Active substance
atazanavir sulfate
International non-proprietary name (INN) or common name
atazanavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE08
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Krka, d.d., Novo mesto
Date of issue of marketing authorisation valid throughout the European Union
25/03/2019
Contact address

KRKA d.d., Novo mesto
Šmarješka cesta 6
SI-8501 Novo mesto
Slovenia

Product information

Atazanavir Krka - EMEA/H/C/004859 -

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Atazanavir Krka 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.

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 Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Assessment history

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