🇪🇺 Micafungin (Mycamine) in European Union

EMA authorised Micafungin (Mycamine) on 25 April 2008

Marketing authorisation

EMA — authorised 25 April 2008

  • Application: EMEA/H/C/000734
  • Marketing authorisation holder: Sandoz Pharmaceuticals d.d.
  • Local brand name: Mycamine
  • Indication: Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. Children (including neonates) and adolescents < 16 years of age treatment of invasive candidiasis. prophylaxis of Candida infection in patients undergoing allogenei
  • Status: approved

Read official source →

Micafungin (Mycamine) in other countries

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

Other Infectious Disease approved in European Union

Frequently asked questions

Is Micafungin (Mycamine) approved in European Union?

Yes. EMA authorised it on 25 April 2008.

Who is the marketing authorisation holder for Micafungin (Mycamine) in European Union?

Sandoz Pharmaceuticals d.d. holds the EU marketing authorisation.