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European Public Assessment Report for Ribavirin BioPartners is updated to reflect that the marketing authorisation is no longer valid.
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\).
Therapeutic Area (MeSH)
ATC Code
J05AB04
ATC Item
N/A
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ribavirin | N/A | ribavirin |
EMA Name
Ribavirin BioPartners
Medicine Name
Ribavirin BioPartners
Aliases
N/ANo risk management plan link.
