Ribavirin Teva Pharma B.V. (ribavirin)
- Region
- 🇪🇺 EU
- Active substance
- ribavirin
- Company
- Teva B.V.
- Status
- Withdrawn
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Thu 23 Apr 2009
- EU approval
- Wed 01 Jul 2009
- Designations
- Generic
- Application
- EMEA/H/C/001064
- ATC
- J05AP01
- Official record
- www.ema.europa.eu
Indication
Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1). Ribavirin Teva Pharma B.V. 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 (see sections 4.2, 4.4 and 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- 🇪🇺 Rebetol Withdrawn · Merck Sharp and Dohme B.V
- 🇪🇺 Ribavirin Mylan (previously Ribavirin Three Rivers) Withdrawn · Mylan S.A.S
- 🇪🇺 Ribavirin Teva Withdrawn · Teva B.V.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 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- 🇪🇺 Cotronak Withdrawn · Schering-Plough Europe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.