Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


EXPIRED  

Product information

Invented name: Ribavirin BioPartners
Auth. number : EU/1/10/626
INN : Ribavirin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AB - Nucleosides
Chemical substance: J05AB04 - Ribavirin
(See WHO ATC Index)
Indication: Treatment of hepatitis C in combination with either peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children over the age of 3 and adolescents)
Marketing Authorisation Holder: BioPartners GmbH
Kaiserpassage 11, D-72764 Reutlingen, Deutschland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
09/04/2010 Centralised - Authorisation EMEA/H/C/1184 (2010)2328 of 06/04/2010
19/11/2010 Centralised - Variation EMEA/H/C/1184/IB/2/G
Updated with Decision(2011)4298 of 14/06/2011
16/06/2011 Centralised - Variation (2011)4298 of 14/06/2011
26/11/2012 Centralised - Variation EMEA/H/C/1184/IB/3/G
10/04/2013 Centralised - Withdrawal