追加説明:
This isavuconazole 200 mg powder for concentrate for solution for infusion is being developed as a generic version referencing Cresemba® (Basilea Pharmaceutica/Pfizer). Isavuconazole is an antifungal indicated in adults for invasive aspergillosis and for mucormycosis when amphotericin B is unsuitable. The dossier is currently in progress, with stability data generated at 2-8°C long term and 25°C/60% RH accelerated conditions; the originator's shelf life is four years, and batch and pack sizes (originator pack: 1 vial x 10 ml per carton) are yet to be finalized.
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