Posaconazole SP (posaconazole)
- Region
- 🇪🇺 EU
- Active substance
- posaconazole
- Company
- Schering-Plough Europe
- Status
- Lapsed
- Therapeutic area
- Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
- EU approval
- Tue 25 Oct 2005
- Application
- EMEA/H/C/000611
- ATC
- J02AC04
- Official record
- www.ema.europa.eu
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 that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.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.Posaconazole SP is also indicated for prophylaxis of invasive fungal infections in the following patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who areat high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Noxafil Authorised · Merck Sharp and Dohme B.V
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- 🇪🇺 Posaconazole AHCL Authorised · Accord Healthcare S.L.U.
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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.