This is a summary of the European public assessment report (EPAR) for Noxafil. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Noxafil.
Noxafil : EPAR - Summary for the public (PDF/80.71 KB)
First published: 28/03/2007
Last updated: 19/11/2014
Noxafil : EPAR - Risk-management-plan summary (PDF/1.72 MB)
First published: 22/10/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp and Dohme B.V
|Date of issue of marketing authorisation valid throughout the European Union||
12/09/2019 Noxafil - EMEA/H/C/000610 - II/0058
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Noxafil 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.
Noxafil 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;
- haematopoietic-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.