This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil 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 Tenofovir disoproxil Mylan. For practical information about using Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
HIV\-1 infection Tenofovir disoproxil 245 mg film\-coated tablets are 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 245 mg film\-coated tablets are also indicated for the treatment of HIV\-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to \< 18 years. The choice of tenofovir disoproxil 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 245 mg film\-coated tablets are 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. * evidence of lamivudine\-resistant hepatitis B virus. * decompensated liver disease. Tenofovir disoproxil 245 mg film\-coated tablets are 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.
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 | N/A | tenofovir disoproxil |
EMA Name
Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan)
Medicine Name
Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan)
Aliases
N/ANo risk management plan link.
