Ribavirin Mylan (previously Ribavirin Three Rivers) (ribavirin)
- Region
- 🇪🇺 EU
- Active substance
- ribavirin
- Company
- Mylan S.A.S
- Status
- Withdrawn
- Therapeutic area
- Hepatitis C, Chronic
- EU approval
- Thu 10 Jun 2010
- Designations
- Generic
- Application
- EMEA/H/C/001185
- ATC
- J05AB04
- Official record
- www.ema.europa.eu
Indication
Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). 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). Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product. Naïve patients Adult patients Ribavirin Mylan 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 serum hepatitis-C-virus (HCV) RNA. Children and adolescents Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three 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 serum 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). Previously treatment-failure patients Adult patients Ribavirin Mylan 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- 🇪🇺 Rebetol Withdrawn · Merck Sharp and Dohme B.V
- 🇪🇺 Ribavirin Teva Withdrawn · Teva B.V.
- 🇪🇺 Ribavirin Teva Pharma B.V. Withdrawn · Teva B.V.
- 🇪🇺 Ribavirin BioPartners Lapsed · BioPartners GmbH
- 🇪🇺 Cotronak Withdrawn · Schering-Plough Europe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.