Ecalta

RSS

anidulafungin

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

Overview

This is a summary of the European public assessment report (EPAR) for Ecalta. 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 Ecalta.

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

This EPAR was last updated on 24/10/2018

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
17
Date of issue of marketing authorisation valid throughout the European Union
19/09/2007
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

26/09/2018 Ecalta - EMEA/H/C/000788 - T/0037

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

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

ANTIMYCOTICS FOR SYSTEMIC USE

Therapeutic indication

Treatment of invasive candidiasis in adult non-neutropenic patients.

Ecalta has been studied primarily in patients with candidaemia and only in a limited number of patients with deep tissue Candida infections or with abscess-forming disease.

Assessment history

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