Alpheon (interferon alfa-2a)
- Region
- 🇪🇺 EU
- Active substance
- interferon alfa-2a
- Company
- BioPartners GmbH
- Status
- Refused
- Therapeutic area
- Hepatitis C, Chronic
- CHMP opinion
- Wed 28 Jun 2006
- Designations
- Biosimilar
- Application
- EMEA/H/C/000585
- ATC
- L03AB04
- Official record
- www.ema.europa.eu
Indication
Adult patients with histologically proven chronic hepatitis C who are positive for hepatitis C virus (HCV) antibodies or HCV RNA and have elevated serum alanine aminotransferase (ALT) without liver decompensation.The efficacy of Interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin. Alpheon should be given alone mainly in case of intolerance or contra-indication to ribavirin.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pegasys Authorised · pharmaand GmbH
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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.