Ecalta

anidulafungin

Table of contents

Opinion

On 30 April 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ecalta. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.

The CHMP adopted an extension to the existing indication, as follows:1

Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold.

Key facts

Name
Ecalta
Agency product number
EMEA/H/C/000788
International non-proprietary name (INN) or common name
  • anidulafungin
Active substance
  • anidulafungin
Therapeutic area
Candidiasis
Date opinion adopted
30/04/2020
Company name
Pfizer Europe MA EEIG
Status
Positive
Application type
Post-authorisation

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