Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - micafungin sodium - powder for concentrate for solution for infusion - micafungin sodium 50 mg - antimycotics for systemic use

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - micafungin sodium - powder for concentrate for solution for infusion - micafungin sodium 100 mg - antimycotics for systemic use

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - micafungin - candidiasis - antimycotics for systemic use - mycamine is indicated for:adults, adolescents ≥ 16 years of age and elderlytreatment 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 agetreatment of invasive candidiasis.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.the decision to use mycamine should take into account a potential risk for the development of liver tumours. mycamine should therefore only be used if other antifungals are not appropriate.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astellas pharma ltd - micafungin sodium - powder for solution for infusion - 50mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astellas pharma ltd - micafungin sodium - powder for solution for infusion - 100mg

Israel - English - Ministry of Health

astellas pharma international b.v., israel - micafungin as sodium - powder for concentrate for solution for infusion - micafungin as sodium 100 mg - micafungin - 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.children (including neonates) and adolescents < 16 years of age:- treatment of invasive candidiasis.- prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.the decision to use mycamine should take into account a potential risk for the development of liver tumours. mycamine should therefore only be used if other antifungals are not appropriate.

Israel - English - Ministry of Health

astellas pharma international b.v., israel - micafungin as sodium - powder for concentrate for solution for infusion - micafungin as sodium 50 mg - micafungin - 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.children (including neonates) and adolescents < 16 years of age:- treatment of invasive candidiasis.- prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.the decision to use mycamine should take into account a potential risk for the development of liver tumours. mycamine should therefore only be used if other antifungals are not appropriate.

Malta - English - Medicines Authority

cz pharma s.r.o. námìstí smiøických 42, 281 63 kostelec kostelec nad cernými lesy,, czech republic - micafungin sodium - powder for concentrate for solution for infusion - micafungin sodium 100 mg - antimycotics for systemic use

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - micafungin sodium - powder for concentrate for solution for infusion - micafungin sodium 10 mg/ml - antimycotics for systemic use

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - micafungin sodium - powder for concentrate for solution for infusion - micafungin sodium 20 mg/ml - antimycotics for systemic use