Overview

The marketing authorisation for Rebetol has been withdrawn at the request of the marketing-authorisation holder

Rebetol : EPAR - Summary for the public

English (EN) (193.98 KB - PDF)

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български (BG) (267.2 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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español (ES) (194.58 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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čeština (CS) (241.62 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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dansk (DA) (193.39 KB - PDF)

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Deutsch (DE) (203.24 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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eesti keel (ET) (188.11 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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ελληνικά (EL) (287.48 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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français (FR) (197.41 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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hrvatski (HR) (230.58 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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italiano (IT) (196.03 KB - PDF)

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latviešu valoda (LV) (245.9 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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lietuvių kalba (LT) (237.77 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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magyar (HU) (230.14 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Malti (MT) (245.17 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Nederlands (NL) (199.38 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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polski (PL) (246.5 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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português (PT) (195.53 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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română (RO) (246.75 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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slovenčina (SK) (238.23 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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slovenščina (SL) (234.18 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Suomi (FI) (187.35 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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svenska (SV) (191.87 KB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Rebetol : EPAR - Risk-management-plan summary

English (EN) (1.86 MB - PDF)

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Product information

Rebetol : EPAR - Product Information

English (EN) (4.78 MB - PDF)

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български (BG) (6.25 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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español (ES) (4.7 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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čeština (CS) (5.65 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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dansk (DA) (4.75 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Deutsch (DE) (6.29 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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eesti keel (ET) (4.38 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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ελληνικά (EL) (6.47 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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français (FR) (5.51 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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hrvatski (HR) (5.21 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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íslenska (IS) (4.62 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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italiano (IT) (5.19 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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latviešu valoda (LV) (5.78 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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lietuvių kalba (LT) (5.62 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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magyar (HU) (5.33 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Malti (MT) (7 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Nederlands (NL) (4.76 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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norsk (NO) (4.55 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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polski (PL) (6.55 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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português (PT) (4.78 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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română (RO) (6.09 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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slovenčina (SK) (5.66 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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slovenščina (SL) (5.46 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Suomi (FI) (5.5 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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svenska (SV) (4.42 MB - PDF)

First published: 22/10/2009Last updated: 07/11/2023
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Latest procedure affecting product information: IAIN/0093/G

24/11/2022

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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)

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български (BG) (129.37 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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español (ES) (39.26 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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čeština (CS) (126.16 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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dansk (DA) (39.69 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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Deutsch (DE) (40.61 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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eesti keel (ET) (40.3 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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ελληνικά (EL) (128.61 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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français (FR) (39.17 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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hrvatski (HR) (316.27 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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íslenska (IS) (129.49 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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italiano (IT) (39.44 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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latviešu valoda (LV) (126.46 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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lietuvių kalba (LT) (126.57 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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magyar (HU) (129.81 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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Malti (MT) (172 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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Nederlands (NL) (38.92 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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norsk (NO) (131.73 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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polski (PL) (131.54 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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português (PT) (39.71 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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română (RO) (119.76 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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slovenčina (SK) (126.46 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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slovenščina (SL) (124.32 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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Suomi (FI) (40.24 KB - PDF)

First published: 26/01/2007Last updated: 07/11/2023
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svenska (SV) (39.8 KB - PDF)

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

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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)

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

AdoptedReference Number: EMA/CHMP/174072/2015

English (EN) (1.86 MB - PDF)

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CHMP post-authorisation summary of positive opinion for Rebetol

AdoptedReference Number: EMA/CHMP/408137/2015

English (EN) (125.43 KB - PDF)

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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)

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

Adopted

English (EN) (2.3 MB - PDF)

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CHMP post-authorisation summary of positive opinion for Rebetol

AdoptedReference Number: EMA/CHMP/114050/2012

English (EN) (177.69 KB - PDF)

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

AdoptedReference Number: EMA/26308/2010

English (EN) (441.73 KB - PDF)

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

AdoptedReference Number: EMA/6094/2010

English (EN) (417.7 KB - PDF)

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CHMP post-authorisation summary of positive opinion for Rebetol

AdoptedReference Number: EMEA/CHMP/609356/2009

English (EN) (63.8 KB - PDF)

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

Adopted

English (EN) (525.99 KB - PDF)

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

Adopted

English (EN) (811.38 KB - PDF)

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

English (EN) (164.46 KB - PDF)

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Rebetol : EPAR - Procedural steps taken before authorisation

English (EN) (140.51 KB - PDF)

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Rebetol : EPAR - Scientific Discussion

English (EN) (1.07 MB - PDF)

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More information on Rebetol

Public statement on Rebetol : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/431866/2023

English (EN) (116.91 KB - PDF)

First published:
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