Ecalta
anidulafungin
Table of contents
Overview
Ecalta is used to treat patients from one month of age with invasive candidiasis (a fungal infection caused by a yeast called Candida). ‘Invasive’ means that the fungus has spread into the bloodstream.
Ecalta contains the active substance anidulafungin.
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List item
Ecalta : EPAR - Medicine overview (PDF/117.96 KB)
First published: 05/11/2009
Last updated: 31/07/2020
EMA/477972/2014 -
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List item
Ecalta : EPAR - Risk management plan (PDF/2.3 MB)
First published: 21/03/2023
Authorisation details
Product details | |
---|---|
Name |
Ecalta
|
Agency product number |
EMEA/H/C/000788
|
Active substance |
anidulafungin
|
International non-proprietary name (INN) or common name |
anidulafungin
|
Therapeutic area (MeSH) |
Candidiasis
|
Anatomical therapeutic chemical (ATC) code |
J02AX06
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
26
|
Date of issue of marketing authorisation valid throughout the European Union |
20/09/2007
|
Contact address |
Boulevard de la Plaine 17 |
Product information
27/06/2023 Ecalta - EMEA/H/C/000788 - IB/0053/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
Antimycotics for systemic use
Therapeutic indication
Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.