Rebetol

RSS

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 Rebetol. 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 Rebetol.

This EPAR was last updated on 26/03/2019

Authorisation details

Product details
Name
Rebetol
Agency product number
EMEA/H/C/000246
Active substance
Ribavirin
International non-proprietary name (INN) or common name
ribavirin
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AP01
Publication details
Marketing-authorisation holder
Merck Sharp and Dohme B.V
Revision
34
Date of issue of marketing authorisation valid throughout the European Union
06/05/1999
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

08/02/2019 Rebetol - EMEA/H/C/000246 - IA/0085

Contents

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

Pharmacotherapeutic group

  • Antivirals for systemic use

  • Antivirals for treatment of HCV infections

Therapeutic indication

Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.

Assessment history

Changes since initial authorisation of medicine

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