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.
Atazanavir Krka : EPAR - Medicine overview (PDF/96.72 KB)
First published: 15/05/2019
Atazanavir Krka : EPAR - Risk-management-plan summary (PDF/112.3 KB)
First published: 15/05/2019
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atazanavir (as sulfate)
|International non-proprietary name (INN) or common name||
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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.
Krka, d.d., Novo mesto
|Date of issue of marketing authorisation valid throughout the European Union||
KRKA d.d., Novo mesto
Atazanavir Krka - EMEA/H/C/004859 -
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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Antivirals for systemic use
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.