← Drug database

Caspofungin Accord (caspofungin)

Generic
Region
🇪🇺 EU
Active substance
caspofungin
Company
Accord Healthcare S.L.U.
Status
Expired
Therapeutic area
Candidiasis; Aspergillosis
EU approval
Thu 11 Feb 2016
Designations
Generic
Application
EMEA/H/C/004134
ATC
J02AX04
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

Follow Caspofungin Accord

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.