Rebetol
ribavirin
Table of contents
Overview
The marketing authorisation for Rebetol has been withdrawn at the request of the marketing-authorisation holder
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List item
Rebetol : EPAR - Summary for the public (PDF/193.98 KB) (updated)
First published: 22/10/2009
Last updated: 07/11/2023 -
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List item
Rebetol : EPAR - Risk-management-plan summary (PDF/1.86 MB) (updated)
First published: 14/10/2019
Last updated: 07/11/2023
Authorisation details
| Product details | |
|---|---|
| Name |
Rebetol
|
| Agency product number |
EMEA/H/C/000246
|
| Active substance |
Ribavirin
|
| International non-proprietary name (INN) or common name |
ribavirin
|
| Therapeutic area (MeSH) |
Hepatitis C, Chronic
|
| Anatomical therapeutic chemical (ATC) code |
J05AP01
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Merck Sharp and Dohme B.V
|
| Revision |
39
|
| Date of issue of marketing authorisation valid throughout the European Union |
06/05/1999
|
| Contact address |
Waarderweg 39 |
Product information
24/11/2022 Rebetol - EMEA/H/C/000246 - IAIN/0093/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.