Noxafil

RSS

posaconazole

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 09/10/2019

Authorisation details

Product details
Name
Noxafil
Agency product number
EMEA/H/C/000610
Active substance
posaconazole
International non-proprietary name (INN) or common name
posaconazole
Therapeutic area (MeSH)
  • Candidiasis
  • Mycoses
  • Coccidioidomycosis
  • Aspergillosis
Anatomical therapeutic chemical (ATC) code
J02AC04
Publication details
Marketing-authorisation holder
Merck Sharp and Dohme B.V
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
25/10/2005
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

06/07/2018 Noxafil - EMEA/H/C/000610 - T/0054

Contents

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Pharmacotherapeutic group

ANTIMYCOTICS FOR SYSTEMIC USE

Therapeutic indication

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.

Assessment history

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