🇪🇺 α-IFN in European Union

EMA authorised α-IFN on 9 March 2000

Marketing authorisation

EMA — authorised 9 March 2000

  • Application: EMEA/H/C/000281
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: IntronA
  • Indication: Chronic hepatitis B Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication (presence of DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis. Chronic hepatitis C Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon. Adult patients IntronA is indicated for the treatment of adult patients with chronic hepatitis C who hav
  • Status: withdrawn

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Frequently asked questions

Is α-IFN approved in European Union?

Yes. EMA authorised it on 9 March 2000.

Who is the marketing authorisation holder for α-IFN in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.