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

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Caspofungin Accord : EPAR - Risk-management-plan summary

Product information

Caspofungin Accord : EPAR - Product Information

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Latest procedure affecting product information: IB/0010

06/02/2020

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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

български (BG) (616.08 KB - PDF)
español (ES) (574.19 KB - PDF)
čeština (CS) (602.91 KB - PDF)
dansk (DA) (574.13 KB - PDF)
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polski (PL) (605.93 KB - PDF)
português (PT) (574.86 KB - PDF)
română (RO) (589.91 KB - PDF)
slovenčina (SK) (604.52 KB - PDF)
slovenščina (SL) (617.85 KB - PDF)
Suomi (FI) (574.25 KB - PDF)
svenska (SV) (574.45 KB - PDF)

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

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

Caspofungin Accord : EPAR - Public assessment report

CHMP summary of opinion for Caspofungin Accord

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