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Micafungin vials

Micafungin* is a semisynthetic lipopeptide from the echinocandin class of antifungal agents. Micafungin is active against most isolates of the following Candida species such as Candida albicans, Candida glabrata, Candida guiliermondii, Candida krusei, Candida parapsilosis and Candida tropicalis.

Indication: Micafungin is indicated for the treatment of invasive candidiasis like blood stream Candida infections and disseminated candidiasis, esophageal candidiasis and for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation and in patients at risk of neutropenia (EU).

Application: Administered by intravenous infusion.

Dosage form

Lyophilized vials

Strength

50 mg

100 mg

Compliance

No monograph for micafungin vials in either Ph. Eur. or USP available

Manufacturing site

CMO for Xellia Pharmaceuticals ApS

Release site

Xellia Pharmaceuticals ApS

Site registered

US FDA

Batch size

50 mg

100 mg

9600 vials

14500 vials

Regulatory documentation

EU dossier

US dossier

Packaging sizes

1 vial/pack

Shelf life

24 months

Storage conditions

Between 15-25°C (68-77°F)

* Product protected by valid patents are not offered for sale in countries where the sale of such product constitutes a patent infringement.