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.
Rebetol : EPAR - Summary for the public (PDF/100.57 KB)
First published: 22/10/2009
Last updated: 10/12/2015
Rebetol ; EPAR - Risk-management-plan summary (PDF/1.7 MB)
First published: 14/10/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hepatitis C, Chronic
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp and Dohme B.V
|Date of issue of marketing authorisation valid throughout the European Union||
31/10/2019 Rebetol - EMEA/H/C/000246 - N/0087
- 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
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Antivirals for systemic use
Antivirals for treatment of HCV infections
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.