Cancidas (previously Caspofungin MSD)

RSS

caspofungin

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 03/04/2019

Authorisation details

Product details
Name
Cancidas (previously Caspofungin MSD)
Agency product number
EMEA/H/C/000379
Active substance
caspofungin
International non-proprietary name (INN) or common name
caspofungin
Therapeutic area (MeSH)
  • Candidiasis
  • Aspergillosis
Anatomical therapeutic chemical (ATC) code
J02AX04
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
23/10/2001
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

25/02/2019 Cancidas (previously Caspofungin MSD) - EMEA/H/C/000379 - IB/0070

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 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 seven 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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