This is a summary of the European public assessment report (EPAR) for Atazanavir Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Atazanavir Mylan. For practical information about using Atazanavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication Atazanavir Viatris, co-administered with low dose ritonavir, is 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). There are very limited data available from children aged 6 to less than 18 years. The choice of Atazanavir Viatrisin treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.
Therapeutic Area (MeSH)
N/AATC Code
J05AE08
ATC Item
atazanavir
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| atazanavir (as sulfate) | N/A | Atazanavir Sulfate/Ritonavir/Lamivudine/Zidovudine |
EMA Name
Atazanavir Mylan
Medicine Name
Atazanavir Viatris (previously Atazanavir Mylan)
Aliases
N/ANo risk management plan link.
