Rebetol

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ribavirin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Rebetol has been withdrawn at the request of the marketing-authorisation holder

This EPAR was last updated on 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
2031 BN Haarlem
The Netherlands

Product information

24/11/2022 Rebetol - EMEA/H/C/000246 - IAIN/0093/G

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Product information documents contain:

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

  • 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.

Assessment history

Changes since initial authorisation of medicine

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