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
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Product information
Caspofungin Accord : EPAR - Product Information
English (EN)
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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
English (EN)
(574.12 KB - PDF)View
български (BG)
(616.08 KB - PDF)
español (ES)
(574.19 KB - PDF)
čeština (CS)
(602.91 KB - PDF)
dansk (DA)
(574.13 KB - PDF)
Deutsch (DE)
(574.19 KB - PDF)
eesti keel (ET)
(574.13 KB - PDF)
ελληνικά (EL)
(615.81 KB - PDF)
français (FR)
(574.36 KB - PDF)
hrvatski (HR)
(588.12 KB - PDF)
íslenska (IS)
(574.01 KB - PDF)
italiano (IT)
(574.31 KB - PDF)
latviešu valoda (LV)
(608.52 KB - PDF)
lietuvių kalba (LT)
(589.08 KB - PDF)
magyar (HU)
(595.5 KB - PDF)
Malti (MT)
(606.79 KB - PDF)
Nederlands (NL)
(574.49 KB - PDF)
norsk (NO)
(574.21 KB - PDF)
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 useTherapeutic 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
Caspofungin Accord : EPAR - Procedural steps taken and scientific information after authorisation
English (EN)
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