Caspofungin Accord

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caspofungin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Caspofungin Accord has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

This EPAR was last updated on 20/08/2021

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
6
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

06/02/2020 Caspofungin Accord - EMEA/H/C/004134 - IB/0010

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Product information documents contain:

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 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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