Ribavirin Teva

Withdrawn

This medicine's authorisation has been withdrawn

ribavirin

Overview

On 22 June 2021, the European Commission withdrew the marketing authorisation for Ribavirin Teva (ribavirin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Ribavirin Teva was granted marketing authorisation in the EU on 31 March 2009 for the treatment of chronic hepatitis C. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. 

Ribavirin Teva is a generic medicine of Rebetol. 

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European Public Assessment Report (EPAR) for Ribavirin Teva is updated to indicate that the marketing authorisation is no longer valid.

Ribavirin Teva : EPAR - Summary for the public

Product information

Ribavirin Teva : EPAR - Product Information

Ribavirin Teva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ribavirin Teva
• Active substance:
  Ribavirin
• International non-proprietary name (INN) or common name:
  ribavirin
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  J05AB04

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used.

There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e. not alfa-2b).

Naïve patients

Adult patients

Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA.

Paediatric patients (children 3 years of age and older and adolescents)

Ribavirin Teva is indicated, in a combination regimen with interferon alfa­2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.

When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis.

Previous treatment failure patients

Adult patients

Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.

Authorisation details

• EMA product number:
  EMEA/H/C/001018
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Teva B.V.

  Swensweg 5; 2031GA Haarlem; The Netherlands

• Marketing authorisation issued:
  31/03/2009
• Withdrawal of marketing authorisation:
  22/06/2021
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Ribavirin Teva : EPAR - Procedural steps taken and scientific information after authorisation

Ribavirin Teva : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/318704/2014

Ribavirin Teva-H-C-1018-II-11 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/461705/2013

Ribavirin Teva-H-C-1018-A20-08 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/12875/2013

Initial marketing authorisation documents

Ribavirin Teva : EPAR - Public assessment report

CHMP summary of positive opinion for Ribavirin Teva