Cresemba
isavuconazole
Table of contents
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.
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List item
Cresemba : EPAR - Summary for the public (PDF/81.36 KB)
First published: 29/10/2015
Last updated: 29/10/2015
EMA/524256/2015 -
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List item
Cresemba : EPAR - Risk-management-plan summary (PDF/48.31 KB)
First published: 29/10/2015
Last updated: 29/10/2015
EMA/576866/2015
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
|
Orphan |
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 | |
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Marketing-authorisation holder |
Basilea Pharmaceutica Deutschland GmbH
|
Revision |
17
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Date of issue of marketing authorisation valid throughout the European Union |
15/10/2015
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Contact address |
Marie-Curie-Strasse 8 |
Product information
19/12/2022 Cresemba - EMEA/H/C/002734 - IB/0040/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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.