Rebetol

Withdrawn

This medicine's authorisation has been withdrawn

ribavirin

Overview

On 18 October 2023, the European Commission withdrew the marketing authorisation for Rebetol (ribavirin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Rebetol was granted marketing authorisation in the EU on 7 May 1999 for the treatment of hepatitis C. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2004. It was then granted unlimited validity in 2009. 

The European Public Assessment Report (EPAR) for Rebetol is updated to indicate that the marketing authorisation is no longer valid.

Rebetol : EPAR - Summary for the public

Rebetol : EPAR - Risk-management-plan summary

Product information

Rebetol : EPAR - Product Information

Rebetol : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Rebetol
• Active substance:
  ribavirin
• International non-proprietary name (INN) or common name:
  ribavirin
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  J05AP01

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000246
• Marketing authorisation holder:
  Merck Sharp and Dohme B.V

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Opinion adopted:
  20/09/2018
• Marketing authorisation issued:
  06/05/1999
• Withdrawal of marketing authorisation:
  18/10/2023
• Revision:
  39

Assessment history

Changes since initial authorisation of medicine

Rebetol : EPAR - Procedural steps taken and scientific information after authorisation

Rebetol-H-C-PSUSA-00010007-202007 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/155557/2021

Rebetol-H-C-246-II-0074: EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/174072/2015

CHMP post-authorisation summary of positive opinion for Rebetol

Adopted Reference Number: EMA/CHMP/408137/2015

Rebetol-H-C-PSUSA-10007-201307 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/317751/2014

Rebetol-H-C-246-WS-0216 : EPAR - Assessment Report - Variation

Adopted

CHMP post-authorisation summary of positive opinion for Rebetol

Adopted Reference Number: EMA/CHMP/114050/2012

Rebetol-H-C-246-II-0048 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/26308/2010

Rebetol-H-C-246-II-0049 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/6094/2010

CHMP post-authorisation summary of positive opinion for Rebetol

Adopted Reference Number: EMEA/CHMP/609356/2009

Rebetol-H-C-246-II-0035 : EPAR - Scientific Discussion - Variation

Adopted

Rebetol-H-C-246-X-0016 : EPAR - Scientific Discussion - Extension

Adopted

Rebetol : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Rebetol : EPAR - Procedural steps taken before authorisation

Rebetol : EPAR - Scientific Discussion