Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CRESEMBA
Active substances:
Isavuconazole
Estonian, English, Latin
ATC code: J02AC05
Dosage form: powder for concentrate for solution for infusion
Strength: 200mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Basilea Pharmaceutica Deutschland GmbH 
Marketing authorization number: EU/1/15/1036 
Marketing authorization issued on: October 15, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1699713  CRESEMBA  powder for concentrate for solution for infusion  200mg 1TK  Prescription      01.03.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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