Viread

RSS

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 Viread. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Viread.

This EPAR was last updated on 15/11/2018

Authorisation details

Product details
Name
Viread
Agency product number
EMEA/H/C/000419
Active substance
tenofovir disoproxil fumarate
International non-proprietary name (INN) or common name
tenofovir disoproxil
Therapeutic area (MeSH)
  • Hepatitis B, Chronic
  • HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AF07
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
50
Date of issue of marketing authorisation valid throughout the European Union
04/02/2002
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

27/09/2018 Viread - EMEA/H/C/000419 - IG/0985

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Viread 123-mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected paediatric patients, with nucleoside-reverse-transcriptase-inhibitor (NRTI) resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg.

The choice of Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and / or treatment history of patients.

Viread 163-mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected paediatric patients, with NRTI resistance or toxicities precluding the use of first-line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg.

The choice of Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and / or treatment history of patients.

Viread 204-mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg.

The choice of Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and / or treatment history of patients.

Viread 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 Viread 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 Viread 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).

Viread 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 Viread to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and / or treatment history of patients.

Viread 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;
  • decompensated liver disease.

Viread 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.

Viread 33-mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not.

Assessment history

Changes since initial authorisation of medicine

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