Ribavirin Teva Pharma B.V.

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ribavirin

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

Overview

This is a summary of the European public assessment report (EPAR) for Ribavirin Teva Pharma B.V. 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 Ribavirin Teva Pharma B.V.

For practical information about using Ribavirin Teva Pharma B.V., patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 02/08/2018

Authorisation details

Product details
Name
Ribavirin Teva Pharma B.V.
Agency product number
EMEA/H/C/001064
Active substance
Ribavirin
International non-proprietary name (INN) or common name
ribavirin
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AB04
GenericGeneric

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
Teva B.V.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
01/07/2009
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

04/11/2016 Ribavirin Teva Pharma B.V. - EMEA/H/C/001064 - IB/0018

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

Ribavirin Teva Pharma B.V. is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three years of age or older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used.

There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).

Naïve patients

Adult patients

Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for HCV ribonucleic acid (HCV-RNA).

Paediatric patients

(children three years of age and older and adolescents)

Ribavirin Teva Pharma B.V. is indicated in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.

When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition, that may be irreversible in some patients.

The decision to treat should be made on a case-by-case basis.

Previous-treatment-failure patients

Adult patients

Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.

Assessment history

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