Ribavirin BioPartners (ribavirin)
- Region
- 🇪🇺 EU
- Active substance
- ribavirin
- Company
- BioPartners GmbH
- Status
- Lapsed
- Therapeutic area
- Hepatitis C, Chronic
- EU approval
- Tue 06 Apr 2010
- Designations
- Generic
- Application
- EMEA/H/C/001184
- ATC
- J05AB04
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Rebetol Withdrawn · Merck Sharp and Dohme B.V
- 🇪🇺 Ribavirin Mylan (previously Ribavirin Three Rivers) Withdrawn · Mylan S.A.S
- 🇪🇺 Ribavirin Teva Withdrawn · Teva B.V.
- 🇪🇺 Ribavirin Teva Pharma B.V. Withdrawn · Teva B.V.
- 🇪🇺 Cotronak Withdrawn · Schering-Plough Europe
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.