🇪🇺 Other parenteral antifungal drugs in European Union

EMA authorised Other parenteral antifungal drugs on 23 October 2001

Marketing authorisations

Application: EMEA/H/C/000379
Local brand name: Cancidas (previously Caspofungin MSD)
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.
Status: approved

Application: EMEA/H/C/002669
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Voriconazole Accord
Indication: Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.
Status: approved

Application: EMEA/H/C/003737
Marketing authorisation holder: Hikma Farmaceutica (Portugal) S.A.
Local brand name: Voriconazole Hikma (previously Voriconazole Hospira)
Indication: Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic
Status: approved

Application: EMEA/H/C/004134
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Caspofungin Accord
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.
Status: withdrawn

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Other parenteral antifungal drugs approved in European Union?

Yes. EMA authorised it on 23 October 2001; EMA authorised it on 16 May 2013; EMA authorised it on 27 May 2015.

Who is the marketing authorisation holder for Other parenteral antifungal drugs in European Union?

Astellas Pharma Europe B.V. is the originator. The local marketing authorisation holder may differ — check the official source linked above.