Rebetol
ribavirin
Table of contents
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.
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List item
Rebetol : EPAR - Summary for the public (PDF/100.57 KB)
First published: 22/10/2009
Last updated: 10/12/2015 -
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List item
Rebetol ; EPAR - Risk-management-plan summary (PDF/1.7 MB)
First published: 14/10/2019
Authorisation details
Product details | |
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Name |
Rebetol
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Agency product number |
EMEA/H/C/000246
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Active substance |
Ribavirin
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International non-proprietary name (INN) or common name |
ribavirin
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Therapeutic area (MeSH) |
Hepatitis C, Chronic
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Anatomical therapeutic chemical (ATC) code |
J05AP01
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Publication details | |
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Marketing-authorisation holder |
Merck Sharp and Dohme B.V
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Revision |
36
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Date of issue of marketing authorisation valid throughout the European Union |
06/05/1999
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Contact address |
Waarderweg 39 |
Product information
31/10/2019 Rebetol - EMEA/H/C/000246 - N/0087
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
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Antivirals for systemic use
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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.