Product class: Authorized package
Medicinal product class: For human use
Package code: 1699713
Name of medicinal product: CRESEMBA
Active substances:
Isavuconazole
Estonian, English, Latin
ATC code: J02AC05
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 200mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: CRESEMBA is indicated in adults for the treatment of • invasive aspergillosis • mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 01 March 2024
Marketing authorization holder: Basilea Pharmaceutica Deutschland GmbH 
Marketing authorization number: EU/1/15/1036 
Marketing authorization issued on: 15 October 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: 04 August 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription