Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Basilea Pharmaceutica Deutschland GmbH, Marie-Curie-Strasse 8, 79539, Lörrach, Germany
CRESEMBA 40 mg hard capsules.
CRESEMBA 100 mg hard capsules.
| Pharmaceutical Form |
|---|
|
CRESEMBA 40 mg hard capsule: Swedish Orange (reddish-brown) capsules marked with “CR40” on the capsule cap in black ink. Capsules length: 15.9 mm. CRESEMBA 100 mg 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. |
Each CRESEMBA 40 mg hard capsule contains 40 mg isavuconazole (as 74.5 mg isavuconazonium sulfate).
Each CRESEMBA 100 mg hard capsule contains 100 mg isavuconazole (as 186.3 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 |
|---|
CRESEMBA 40 mg hard capsulesCapsule contents: Magnesium citrate (anhydrous) Capsule shell: Hypromellose Printing ink: Shellac (E904) CRESEMBA 100 mg hard capsulesCapsule contents: Magnesium citrate (anhydrous) Capsule shell: Hypromellose Printing ink: Shellac (E904) |
CRESEMBA 40 mg hard capsules: 35 hard capsules (in seven aluminum blisters), with each capsule pocket connected to a pocket with desiccant.
CRESEMBA 100 mg hard capsules: 14 hard capsules (in two aluminum blisters), with each capsule pocket connected to a pocket with desiccant.
Basilea Pharmaceutica Deutschland GmbH, Marie-Curie-Strasse 8, 79539, Lörrach, Germany
CRESEMBA 40 mg hard capsules: EU/1/15/1036/003
CRESEMBA 100 mg hard capsules: EU/1/15/1036/002
CRESEMBA 100 mg hard capsules:
Date of first authorisation: 15 October 2015
Date of latest renewal: 13 August 2020
| 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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