Rebetol (ribavirin)
- Region
- 🇪🇺 EU
- Active substance
- ribavirin
- Company
- Merck Sharp and Dohme B.V
- Status
- Withdrawn
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Thu 20 Sep 2018
- EU approval
- Thu 06 May 1999
- Application
- EMEA/H/C/000246
- ATC
- J05AP01
- Official record
- www.ema.europa.eu
Indication
Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ribavirin Mylan (previously Ribavirin Three Rivers) Withdrawn · Mylan S.A.S
- 🇪🇺 Ribavirin Teva Withdrawn · Teva B.V.
- 🇪🇺 Ribavirin Teva Pharma B.V. Withdrawn · Teva B.V.
- 🇪🇺 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- 🇪🇺 Cotronak Withdrawn · Schering-Plough Europe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.