Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Ribavirin

Product name: Ribavirin
INN: ribavirin
Indication: Ribavirin (RBV) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses. Antiviral activity is associated with the phosphorylated metabolites of ribavirin. Ribavirin is not effective when used alone for treatment of Chronic hepatitis C (CHC). However, when used in combination with interferon alfa or pegylated interferon alfa for the treatment of CHC, RBV has been shown to increase the efficacy of interferon alfa used alone.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/04/2014 Centralised - Modification EMEA/H/C/PSUSA/10007/201307 (2014)2923 of 28/04/2014