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

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd, - micafungin - powder for concentrate for solution for infusion - 100 milligram(s) - micafungin

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd, - micafungin - powder for concentrate for solution for infusion - 50 milligram(s) - micafungin

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

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection 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 micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatri

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection 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 micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatri

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection 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 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 - micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to candida . - the efficacy of micafungin for injection against infections caused by fungi other than candida has not been established. additional pediatric use information is approved for astellas pharma us, inc.'s mycamine ® (micafungin for injection). however, due to astellas pharma us, inc.'s mark