Rebetol

Withdrawn

This medicine's authorisation has been withdrawn

ribavirin

MedicineHumanWithdrawn

Application under evaluation
CHMP opinion
European Commission decision

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The European Public Assessment Report (EPAR) for Rebetol is updated to indicate that the marketing authorisation is no longer valid.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

English (EN) (193.98 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023

Other languages (22)

Rebetol : EPAR - Risk-management-plan summary

English (EN) (1.86 MB - PDF)

First published: 14/10/2019Last updated: 07/11/2023

Product information

Rebetol : EPAR - Product Information

English (EN) (4.78 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023

Other languages (24)

Latest procedure affecting product information: IAIN/0093/G

24/11/2022

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

Rebetol : EPAR - All Authorised presentations

English (EN) (37.03 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023

Other languages (24)

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
Marketing authorisation issued: 06/05/1999
Revision: 39

Assessment history

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

English (EN) (1.29 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023

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

English (EN) (168.49 KB - PDF)

First published: 30/06/2021Last updated: 07/11/2023

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

AdoptedReference Number: EMA/CHMP/174072/2015

English (EN) (1.86 MB - PDF)

First published: 09/12/2015Last updated: 07/11/2023

CHMP post-authorisation summary of positive opinion for Rebetol

AdoptedReference Number: EMA/CHMP/408137/2015

English (EN) (125.43 KB - PDF)

First published: 25/09/2015Last updated: 07/11/2023

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

English (EN) (114.24 KB - PDF)

First published: 10/06/2014Last updated: 07/11/2023

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

Adopted

English (EN) (2.3 MB - PDF)

First published: 30/05/2012Last updated: 07/11/2023

CHMP post-authorisation summary of positive opinion for Rebetol

AdoptedReference Number: EMA/CHMP/114050/2012

English (EN) (177.69 KB - PDF)

First published: 17/02/2012Last updated: 07/11/2023

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

AdoptedReference Number: EMA/26308/2010

English (EN) (441.73 KB - PDF)

First published: 22/01/2010Last updated: 07/11/2023

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

AdoptedReference Number: EMA/6094/2010

English (EN) (417.7 KB - PDF)

First published: 22/01/2010Last updated: 07/11/2023

CHMP post-authorisation summary of positive opinion for Rebetol

AdoptedReference Number: EMEA/CHMP/609356/2009

English (EN) (63.8 KB - PDF)

First published: 24/09/2009Last updated: 07/11/2023

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

Adopted

English (EN) (525.99 KB - PDF)

First published: 03/12/2007Last updated: 07/11/2023

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

Adopted

English (EN) (811.38 KB - PDF)

First published: 11/08/2006Last updated: 07/11/2023

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

English (EN) (164.46 KB - PDF)

First published: 11/08/2006Last updated: 07/11/2023

Rebetol : EPAR - Procedural steps taken before authorisation

English (EN) (140.51 KB - PDF)

First published: 11/08/2006Last updated: 07/11/2023

Rebetol : EPAR - Scientific Discussion

English (EN) (1.07 MB - PDF)

First published: 11/08/2006Last updated: 07/11/2023

News on Rebetol

This page was last updated on 07/11/2023