Ribavirin BioPartners

Lapsed

This medicine's authorisation has lapsed

ribavirin

Overview

On 09 April 2010, the European Commission (EC) issued a marketing authorisation valid throughout the European Union (EU) for the medicinal product Ribavirin BioPartners (ribavirin), indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three years of age and older and adolescents. 

The Marketing Authorisation Holder (MAH) responsible for Ribavirin BioPartners was BioPartners GmbH. Ribavirin BioPartners has not been marketed anywhere in the EU since the granting of the marketing authorisation. As the product has not been marketed for three consecutive years, in accordance with Article 14(4) of Regulation (EC) N° 726/2004 (“Sunset Clause”), the marketing authorisation of Ribavirin BioPartners has ceased to be valid. BioPartners GmbH was notified accordingly by letter dated 09 April 2013. 

The European Public Assessment Report for Ribavirin BioPartners is updated to reflect that the marketing authorisation is no longer valid.

Ribavirin BioPartners : EPAR - Summary for the public

Product information

Ribavirin BioPartners : EPAR - Product Information

Ribavirin BioPartners : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ribavirin BioPartners
• 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 BioPartners is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three 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 BioPartners 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) (see section 4.4)

Children three years of age and older and adolescents

Ribavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, 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 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).

Previous-treatment-failure patients

Adult patients

Ribavirin BioPartners 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 alfa monotherapy but who have subsequently relapsed (see section 5.1).

Authorisation details

• EMA product number:
  EMEA/H/C/001184
• 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:
  BioPartners GmbH

  Kaiserpassage 11; D-72764 Reutlingen; Germany

• Marketing authorisation issued:
  06/04/2010
• Lapse of marketing authorisation:
  09/04/2013
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Ribavirin BioPartners : EPAR - Public assessment report

CHMP summary of positive opinion for Ribavirin BioPartners

AdoptedReference Number: EMA/CHMP/40892/2010