Ribavirin Teva Pharma B.V.

Withdrawn

This medicine's authorisation has been withdrawn

ribavirin

Overview

The marketing authorisation for Ribavirin Teva Pharma B. V. has been withdrawn at the request of the marketing-authorisation holder.

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
• 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