Ribavirin Mylan (previously Ribavirin Three Rivers)

Withdrawn

This medicine's authorisation has been withdrawn

ribavirin

Overview

On 27 October 2020, the European Commission withdrew the marketing authorisation for Ribavirin Mylan (ribavirin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mylan S.A.S, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Ribavirin Mylan was granted marketing authorisation in the EU on 10 June 2010 for treatment of chronic hepatitis C. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2015. The product had not been marketed in the EU since June 2018. 

Ribavirin Mylan is a generic medicine of Rebetol. There are other generic medicinal products of Rebetol authorised and marketed in the EU. 

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European Public Assessment Report (EPAR) for Ribavirin Mylan is updated to indicate that the marketing authorisation is no longer valid.

Ribavirin Mylan: EPAR - Summary for the public

Product information

Ribavirin Mylan : EPAR - Product Information

Ribavirin Mylan : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ribavirin Mylan (previously Ribavirin Three Rivers)
• 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 Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). 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).

Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product.

Naïve patients

Adult patients

Ribavirin Mylan 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 serum hepatitis-C-virus (HCV) RNA.

Children and adolescents

Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three 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 serum HCV RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4).

Previously treatment-failure patients

Adult patients

Ribavirin Mylan 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/001185
• 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:
  Mylan S.A.S

  117 Allee des Parcs; 69800 Saint-Priest; France

• Marketing authorisation issued:
  10/06/2010
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

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

Ribavirin Mylan-H-C-1185-PSUSA-10007-201307 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/318854/2014

Initial marketing authorisation documents

Ribavirin Three Rivers : EPAR - Public assessment report

CHMP positive summary of opinion for Ribavirin Three Rivers

Adopted Reference Number: EMA/CHMP/143985/2010