Caspofungin Accord

Withdrawn

This medicine's authorisation has been withdrawn

caspofungin

Overview

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

Caspofungin Accord : EPAR - Summary for the public

Caspofungin Accord : EPAR - Risk-management-plan summary

Product information

Caspofungin Accord : EPAR - Product Information

Latest procedure affecting product information: IB/0010

06/02/2020

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Caspofungin Accord : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Caspofungin Accord
• Active substance:
  caspofungin acetate
• International non-proprietary name (INN) or common name:
  caspofungin
• Therapeutic area (MeSH):
  • Candidiasis
  • Aspergillosis
• Anatomical therapeutic chemical (ATC) code:
  J02AX04

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004134
• Generic:

  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.

• Marketing authorisation holder:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Marketing authorisation issued:
  11/02/2016
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Caspofungin Accord : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Caspofungin Accord : EPAR - Public assessment report

AdoptedReference Number: EMA/32587/2016

CHMP summary of opinion for Caspofungin Accord

AdoptedReference Number: EMA/CHMP/843681/2015