Caspofungin Accord

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caspofungin

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

Overview

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

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

This EPAR was last updated on 24/06/2019

Authorisation details

Product details
Name
Caspofungin Accord
Agency product number
EMEA/H/C/004134
Active substance
caspofungin acetate
International non-proprietary name (INN) or common name
caspofungin
Therapeutic area (MeSH)
  • Candidiasis
  • Aspergillosis
Anatomical therapeutic chemical (ATC) code
J02AX04
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
11/02/2016
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

29/04/2019 Caspofungin Accord - EMEA/H/C/004134 - N/0008

Contents

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 or paediatric patients.
  • Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
  • Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.

Assessment history

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