🇪🇺 SCH 56592 in European Union

EMA authorised SCH 56592 on 25 October 2005

Marketing authorisations

Application: EMEA/H/C/000610
Marketing authorisation holder: Merck Sharp and Dohme B.V
Local brand name: Noxafil
Indication: Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following invasive fungal infections in adult and paediatric patients from 2 years of age:  Invasive aspergillosis  Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole
Status: approved

Application: EMEA/H/C/000611
Marketing authorisation holder: Schering-Plough Europe
Local brand name: Posaconazole SP
Indication: Posaconazole SP is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease
Status: withdrawn

Application: EMEA/H/C/005005
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Posaconazole Accord
Indication: Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults: Invasive aspergillosis; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined a
Status: approved

Application: EMEA/H/C/005028
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Posaconazole AHCL
Indication: Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease tha
Status: approved

Is SCH 56592 approved in European Union?

Yes. EMA authorised it on 25 October 2005; EMA authorised it on 25 October 2005; EMA authorised it on 25 July 2019.

Who is the marketing authorisation holder for SCH 56592 in European Union?

Merck Sharp and Dohme B.V holds the EU marketing authorisation.