Ribavirin Mylan (previously Ribavirin Three Rivers)

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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 Mylan. 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 Ribavirin Mylan.

This EPAR was last updated on 16/08/2016

Authorisation details

Product details
Name
Ribavirin Mylan (previously Ribavirin Three Rivers)
Agency product number
EMEA/H/C/001185
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
Generics [UK] Ltd
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
10/06/2010
Contact address
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom

Product information

29/07/2016 Ribavirin Mylan (previously Ribavirin Three Rivers) - EMEA/H/C/001185 - IB/0025

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 Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). 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).

Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product.

Naïve patients

Adult patients

Ribavirin Mylan 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 serum hepatitis-C-virus (HCV) RNA.

Children and adolescents

Ribavirin Mylan 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 serum HCV RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4).

Previously treatment-failure patients

Adult patients

Ribavirin Mylan 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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