This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil Zentiva. 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 Tenofovir disoproxil Zentiva. For practical information about using Tenofovir disoproxil Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
**HIV?1 infection** Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV?1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV?1 infection is based on results of one study in treatment?naïve patients, including patients with a high viral load (\> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre?treated patients experiencing early virological failure (\< 10,000 copies/ml, with the majority of patients having \< 5,000 copies/ml). Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV?1 infected adolescents, with NRTI (nucleotide reverse transcriptase inhibitor) resistance or toxicities precluding the use of first line agents, aged 12 to \< 18 years. The choice of Tenofovir disoproxil Zentiva to treat antiretroviral?experienced patients with HIV?1 infection should be based on individual viral resistance testing and/or treatment history of patients. **Hepatitis B infection** Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with: * compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5\.1\); * evidence of lamivudine\-resistant hepatitis B virus (see sections 4\.8 and 5\.1\); * decompensated liver disease (see sections 4\.4, 4\.8 and 5\.1\). Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents 12 to \< 18 years of age with: * compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4\.4, 4\.8 and 5\.1\).
Therapeutic Area (MeSH)
ATC Code
J05AF07
ATC Item
N/A
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| tenofovir disoproxil phosphate | N/A | tenofovir disoproxil phosphate |
EMA Name
Tenofovir disoproxil Zentiva
Medicine Name
Tenofovir disoproxil Zentiva
Aliases
N/ANo risk management plan link.
