Malta - angielski - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - powder for concentrate for solution for infusion - micafungin sodium 10 mg/ml - antimycotics for systemic use

Australia - angielski - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - micafungin sodium, quantity: 101.73 mg (equivalent: micafungin, qty 100 mg) - injection, powder for - excipient ingredients: citric acid; sodium hydroxide; lactose monohydrate - mycamine is indicated for: ? treatment of invasive candidiasis in children and adults ? treatment of oesophageal candidiasis in adults, adolescents greater than or equal to 16 years of age and the elderly patients for whom intravenous therapy is appropriate ? prophylaxis of candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/?l) for 10 or more days.

Australia - angielski - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - micafungin sodium, quantity: 50.86 mg (equivalent: micafungin, qty 50 mg) - injection, powder for - excipient ingredients: citric acid; sodium hydroxide; lactose monohydrate - mycamine is indicated for: ? treatment of invasive candidiasis in children and adults ? treatment of oesophageal candidiasis in adults, adolescents greater than or equal to 16 years of age and the elderly patients for whom intravenous therapy is appropriate ? prophylaxis of candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/?l) for 10 or more days.

Izrael - angielski - Ministry of Health

ofek pharma ltd, 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 esophageal candidiasis in patients for whom intravenous therapy is appropriate. prophylaxis of candida infections in patients undergoing allogeneic hematopoietic stem cell transplantation. children (including neonates) and adolescents < 16 years of age: treatment of invasive candidiasis. prophylaxis of candida in patient undergoing hematopoietic stem cell transplantation. the decision to use micafungin should take into account a potential risk for the development of the liver. micafungin should therefore only be used if other antifungals are not appropriate

Izrael - angielski - Ministry of Health

ofek pharma ltd, 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 esophageal candidiasis in patients for whom intravenous therapy is appropriate. prophylaxis of candida infections in patients undergoing allogeneic hematopoietic stem cell transplantation. children (including neonates) and adolescents < 16 years of age: treatment of invasive candidiasis. prophylaxis of candida in patient undergoing hematopoietic stem cell transplantation. the decision to use micafungin should take into account a potential risk for the development of the liver. micafungin should therefore only be used if other antifungals are not appropriate

Izrael - angielski - Ministry of Health

k.s.kim international (sk- pharma) ltd., 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 esophageal 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 micafungin s.k. should take into account a potential risk for the development of liver tumours. micafungin s.k. should therefore only be used if other antifungals are not appropriate.

Izrael - angielski - Ministry of Health

k.s.kim international (sk- pharma) ltd., 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 esophageal 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 micafungin s.k. should take into account a potential risk for the development of liver tumours. micafungin s.k. should therefore only be used if other antifungals are not appropriate.

Kanada - angielski - Health Canada

astellas pharma canada inc - micafungin sodium - powder for solution - 100mg - micafungin sodium 100mg - echinocandins

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

astellas pharma us, inc. - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin sodium 10 mg in 1 ml - mycamine® is indicated for:     •    treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older [see clinical studies (14.1) and use in specific populations (8.4)] .     •    treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see use in specific populations (8.4)] .     •    treatment of esophageal candidiasis in adult and pediatric patients 4 months of age and older [see clinical studies (14.2)] .     •    prophylaxis of candida infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see clinical studies (14.3)] . limitations of use     •    the safety and effectiveness of mycamine have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in p

Kenia - angielski - Pharmacy and Poisons Board

astellas pharma (pty) ltd 5 osborne lane, bedfordview south africa - micafungin - powder for solution for infusion - 100 mg micafungin powder for solution for… - micafungin