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 summary (PDF/113.2 KB)
First published: 31/07/2020
This EPAR was last updated on 31/07/2020
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 | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
22
|
Date of issue of marketing authorisation valid throughout the European Union |
20/09/2007
|
Contact address |
Product information
03/06/2020 Ecalta - EMEA/H/C/000788 - II/0040
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antimycotics for systemic use
Therapeutic indication
Therapeutic indication
Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.