Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 02 March 2018

Indication(s)

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 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.
- evidence of lamivudine-resistant hepatitis B virus.
- decompensated liver disease.

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.

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Category Value
Agency product number EMEA/H/C/004120
Orphan designation No
Date First Approved 15-09-2016
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Zentiva k.s.