Posaconazole AHCL (posaconazole)
- Region
- 🇪🇺 EU
- Active substance
- posaconazole
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Mycoses
- CHMP opinion
- Wed 29 May 2019
- EU approval
- Thu 25 Jul 2019
- Designations
- Generic
- Application
- EMEA/H/C/005028
- ATC
- J02AC04
- Official record
- www.ema.europa.eu
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 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 AHCL oral suspension 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 are at 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
- 🇪🇺 Posaconazole Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Posaconazole SP Lapsed · Schering-Plough Europe
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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.