CRESEMBA Powder for concentrate for solution for infusion Ref.[9617] Active ingredients: Isavuconazole

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Basilea Pharmaceutica Deutschland GmbH, Marie-Curie-Strasse 8, 79539, Lรถrrach, Germany

Product name and form

CRESEMBA 200 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White to yellow powder.

Qualitative and quantitative composition

Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium sulfate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Isavuconazole

Isavuconazole is an active form of isavuconazonium. Isavuconazole inhibits lanosterol 14-alpha demethylase (or CYP51A1) and leads to the accumulation of ergosterol toxic precursors in the fungal cytoplasm. Isavuconazole is indicated for the treatment of invasive aspergillosis and invasive mucormycosis.

List of Excipients

Mannitol
Sulfuric acid (for pH-adjustment)

Pack sizes and marketing

One 10 mL Type I glass vial with rubber stopper and an aluminum cap with plastic seal.

Marketing authorization holder

Basilea Pharmaceutica Deutschland GmbH, Marie-Curie-Strasse 8, 79539, Lรถrrach, Germany

Marketing authorization dates and numbers

EU/1/15/1036/001

Date of first authorisation: 15 October 2015

Drugs

Drug Countries
CRESEMBA Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States

ยฉ All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.