🇪🇺 PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin in European Union

EMA authorised PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin on 6 May 1999

Marketing authorisation

EMA — authorised 6 May 1999

  • Application: EMEA/H/C/000246
  • Marketing authorisation holder: Merck Sharp and Dohme B.V
  • Local brand name: Rebetol
  • 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.
  • Status: withdrawn

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PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin approved in European Union?

Yes. EMA authorised it on 6 May 1999.

Who is the marketing authorisation holder for PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin in European Union?

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