CRESEMBA Hard capsule Ref.[9619] Active ingredients: Isavuconazole

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

Product name and form

CRESEMBA 100 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Swedish Orange (reddish-brown) capsule body marked with “100” in black ink and a white cap marked with “C” in black ink. Capsules length: 24.2 mm.

Qualitative and quantitative composition

For the full list of excipients, see section 6.1.

Each capsule contains 100 mg isavuconazole (as 186.3 mg isavuconazonium sulfate).

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

Capsule contents:

Magnesium citrate (anhydrous)
Microcrystalline cellulose
Talc
Silica, colloidal anhydrous
Stearic acid

Capsule shell:

Hypromellose
Water
Red iron oxide (E172) (capsule body only)
Titanium dioxide (E171)
Gellan gum
Potassium acetate
Disodium edetate
Sodium laurilsulfate

Printing ink:

Shellac
Propylene glycol
Potassium hydroxide
Black iron oxide (E172)

Pack sizes and marketing

14 hard capsules (in two aluminum blisters), with each capsule pocket connected to a pocket with desiccant.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/15/1036/002

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
 
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