Noxafil

Ce que l’EMA publie pour Noxafil

L’EMA publie plusieurs indications réglementaires pour Noxafil. Le texte officiel est reproduit ci-dessous.

Domaines thérapeutiques associés dans le jeu EMA

Classification taxonomique du jeu EMA

• candidoseEMA · Candidiasis
• mycosesEMA · Mycoses
• coccidioïdomycoseEMA · Coccidioidomycosis
• aspergilloseEMA · Aspergillosis

Ces libellés sont une taxonomie EMA, pas une formulation d’indication patient.

Indication réglementaire officielle

Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following invasive fungal infections in adult and paediatric patients from 2 years of age: Invasive aspergillosis 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. 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 concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in adults and paediatric patients from 2 years of age: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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 (GVHD) and who are at high risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in adults with oropharyngeal candidiasis. Noxafil gastro-resistant tablets are indicated for use in the treatment of the following invasive fungal infections in adults and paediatric patients from 2 years of age weighing more than 40 kg: Invasive aspergillosis 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. Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in adults and paediatric patients from 2 years of age weighing more than 40 kg: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil oral suspension 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. Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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. Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following invasive fungal infections in paediatric patients from 2 years of age: Invasive aspergillosis 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. Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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.

Texte officiel EMA en anglais, non traduit par Medyx. Page source ↗

Information produit et documents officiels

Autres documents officiels liés

• Présentations autorisées

  Liste des présentations autorisées au niveau européen.

  Noxafil : EPAR - All Authorised presentations ↗
• Aperçu EPAR

  Résumé public de l’évaluation européenne du médicament.

  Noxafil : EPAR - Medicine overview ↗
• Plan de gestion des risques

  Document décrivant les mesures de minimisation des risques publiées par l’EMA.

  Noxafil : EPAR - Risk management plan ↗

Quelle est la dernière mise à jour EMA disponible ?

Le jeu EMA indique la révision 43 et une dernière mise à jour de page au 1 juillet 2026. Dernière procédure publiée affectant l’information produit : VR/0000263360.

Qu’est-ce qui a changé récemment ?

Aucune détection Medyx publiée pour ce médicament dans le corpus public actuel.

• Voir l’information produit EMA (dont le RCP)
• Voir le fichier de changements suivis EMA
• Dernière mise à jour EMA de la page : 1 juillet 2026

Quelle est sa substance active ?

• posaconazole

Informations réglementaires

Numéro de produit EMA

EMEA/H/C/000610

DCI / nom commun

posaconazole

Code ATC

J02AC04

Groupe pharmacothérapeutique

Triazole and triazole derivatives

Titulaire d’AMM

Merck Sharp and Dohme B.V

Statut

Autorisé

Date d’autorisation

25 octobre 2005

Décision Commission (jeu EMA)

5 mars 2026

Médicaments liés

• Posaconazole Accordposaconazole

Retour au hub médicaments

Sources et provenance

Fournisseur

European Medicines Agency

Page source

Page médicament EMA ↗

Date source (page EMA)

1 juillet 2026

Horodatage du jeu EMA

2026-09-09T06:12:45Z

Statut (valeur EMA d’origine)

Authorised

Révision

43

Empreinte de la fiche publique

sha256:4f961e24789385f87e94758ee579d657df2644cb53e8bb1fc99b4e0054f129a8

Cette empreinte couvre la fiche publique telle qu’elle est affichée : identité EMA, substances, code ATC, domaines thérapeutiques, titulaire d’AMM, dates, révision, indication, documents liés et cas publics. Elle ne couvre pas le PDF source.