Atazanavir Krka
atazanavir
Table of contents
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.
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Atazanavir Krka : EPAR - Medicine overview (PDF/96.72 KB)
First published: 15/05/2019
EMA/107659/2019 -
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Atazanavir Krka : EPAR - Risk-management-plan summary (PDF/112.3 KB)
First published: 15/05/2019
Authorisation details
Product details | |
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Name |
Atazanavir Krka
|
Agency product number |
EMEA/H/C/004859
|
Active substance |
atazanavir (as sulfate)
|
International non-proprietary name (INN) or common name |
atazanavir
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AE08
|
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. |
Publication details | |
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Marketing-authorisation holder |
Krka, d.d., Novo mesto
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
25/03/2019
|
Contact address |
KRKA d.d., Novo mesto |
Product information
06/06/2023 Atazanavir Krka - EMEA/H/C/004859 - IB/0003
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.