Tenofovir disoproxil Zentiva

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tenofovir disoproxil

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 01/03/2018

Authorisation details

Product details
Name
Tenofovir disoproxil Zentiva
Agency product number
EMEA/H/C/004120
Active substance
tenofovir disoproxil phosphate
International non-proprietary name (INN) or common name
tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AF07
Generic

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.

Publication details
Marketing-authorisation holder
Zentiva k.s.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
14/09/2016
Contact address
U Kabelovny 130
Dolni Mecholupy 102 37
Prague 10
Czech Republic

Product information

18/01/2018 Tenofovir disoproxil Zentiva - EMEA/H/C/004120 - IB/0007/G

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

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).

Assessment history

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