Noxafil is an antifungal medicine that is used to treat adults and children from 2 years of age with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) have not worked or are not suitable:
- invasive aspergillosis (fungal infection caused by Aspergillus);
- fusariosis (fungal infection caused by Fusarium);
- chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters);
- coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
In adults, Noxafil is also used as a first treatment for invasive aspergillosis and for fungal infections of the mouth and throat caused by Candida (thrush). It is used in patients whose thrush infection is severe or who have weakened immune systems, when medicines applied topically (directly on the thrush) are unlikely to work.
Noxafil is also used to prevent invasive fungal infections in patients from 2 years of age whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a transplant of cells that make blood cells).
Noxafil contains the active substance posaconazole.
Noxafil : EPAR - Summary for the public (PDF/145.01 KB)
First published: 28/03/2007
Last updated: 26/01/2022
Noxafil : EPAR - Risk-management-plan summary (PDF/103.8 KB)
First published: 22/10/2019
Last updated: 26/01/2022
|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||
13/01/2023 Noxafil - EMEA/H/C/000610 - IAIN/0079
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Antimycotics for systemic use
Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):
Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):
Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4.2 and 5.1):
Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):