Ribavirin Teva Pharma B.V.

Withdrawn

This medicine's authorisation has been withdrawn

ribavirin

Overview

On 22 June 2021, the European Commission withdrew the marketing authorisation for Ribavirin Teva Pharma BV (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 Pharma BV was granted marketing authorisation in the EU on 1 July 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 Pharma BV is a generic medicine of Rebetol. 

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Public Assessment Report (EPAR) for Ribavirin Teva Pharma BV is updated to indicate that the marketing authorisation is no longer valid.

Ribavirin Teva Pharma B.V. : EPAR - Medicine overview

Product information

Ribavirin Teva Pharma B.V. : EPAR - Product Information

Ribavirin Teva Pharma B.V. : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ribavirin Teva Pharma B.V.
• 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

Therapeutic indication

Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).

Ribavirin Teva Pharma B.V. 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 (see sections 4.2, 4.4 and 5.1).

Authorisation details

• EMA product number:
  EMEA/H/C/001064
• 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

• Opinion adopted:
  23/04/2009
• Marketing authorisation issued:
  01/07/2009
• Withdrawal of marketing authorisation:
  22/06/2021
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

Ribavirin Teva Pharma B.V. : EPAR - Procedural steps taken and scientific information after authorisation

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

Reference Number: EMA/CHMP/318726/2014

Ribavirin Teva Pharma B.V.-H-C-1064-II-10 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/461787/2013

Ribavirin Teva Pharma B.V.-H-C-1064-A20-07 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/13297/2013

Initial marketing authorisation documents

Ribavirin Teva Pharma B.V. : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Ribavirin Teva Pharma BV

Reference Number: EMEA/CHMP/228100/2009