Cresemba

RSS

isavuconazole

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Cresemba. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cresemba.

For practical information about using Cresemba, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 22/10/2019

Authorisation details

Product details
Name
Cresemba
Agency product number
EMEA/H/C/002734
Active substance
isavuconazole
International non-proprietary name (INN) or common name
isavuconazole
Therapeutic area (MeSH)
Aspergillosis
Anatomical therapeutic chemical (ATC) code
J02AC
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Basilea Pharmaceutica Deutschland GmbH
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
15/10/2015
Contact address

Marie-Curie-Strasse 8
79539 Lörrach
Germany

Product information

26/09/2019 Cresemba - EMEA/H/C/002734 - II/0024/G

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Not yet assigned

Therapeutic indication

Cresemba is indicated in adults for the treatment of:

  • invasive aspergillosis
  • mucormycosis in patients for whom amphotericin B is inappropriate

Consideration should be given to official guidance on the appropriate use of antifungal agents.

Assessment history

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