Ribavirin Teva (ribavirin)
- Region
- 🇪🇺 EU
- Active substance
- ribavirin
- Company
- Teva B.V.
- Status
- Withdrawn
- Therapeutic area
- Hepatitis C, Chronic
- EU approval
- Tue 31 Mar 2009
- Designations
- Generic
- Application
- EMEA/H/C/001018
- ATC
- J05AB04
- Official record
- www.ema.europa.eu
Indication
Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 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 Teva 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. Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Teva is indicated, in a combination regimen with interferon alfa2b, for the treatment of children and adolescents 3 years of age and older, 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 not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis. Previous treatment failure patients Adult patients Ribavirin Teva 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 alpha monotherapy but who have subsequently relapsed.
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- 🇪🇺 Rebetol Withdrawn · Merck Sharp and Dohme B.V
- 🇪🇺 Ribavirin Mylan (previously Ribavirin Three Rivers) Withdrawn · Mylan S.A.S
- 🇪🇺 Ribavirin Teva Pharma B.V. Withdrawn · Teva B.V.
- 🇪🇺 Ribavirin BioPartners Lapsed · BioPartners GmbH
- 🇪🇺 Cotronak Withdrawn · Schering-Plough Europe
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