Caspofungin Accord
caspofungin
Table of contents
Overview
The marketing authorisation for Caspofungin Accord has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
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Caspofungin Accord : EPAR - Summary for the public (PDF/656.45 KB)
First published: 21/03/2016
Last updated: 21/03/2016 -
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Caspofungin Accord : EPAR - Risk-management-plan summary (PDF/653.07 KB)
First published: 21/03/2016
Last updated: 21/03/2016
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) |
|
| Anatomical therapeutic chemical (ATC) code |
J02AX04
|
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. |
| 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 |
Accord Healthcare S.L.U. |
Product information
06/02/2020 Caspofungin Accord - EMEA/H/C/004134 - IB/0010
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).
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.