Posaconazole AHCL

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posaconazole

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

Overview

Posaconazole AHCL is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed: 

  • 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). 

Posaconazole AHCL is also used as a first-line treatment for ‘thrush’, a fungal infection of the mouth and throat due to Candida. It is used in patients whose infection is severe or in patients with weakened immune systems, when medicines applied topically (directly on the thrush) are unlikely to work.

Posaconazole AHCL is also used to prevent invasive fungal infections in patients 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 procedure where the patient’s bone marrow is replaced by stem cells from a donor to form new bone marrow).

Posaconazole AHCL contains the active substance posaconazole and is a ‘generic medicine’. This means that Posaconazole AHCL contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Noxafil. 

This EPAR was last updated on 28/08/2019

Authorisation details

Product details
Name
Posaconazole AHCL
Agency product number
EMEA/H/C/005028
Active substance
posaconazole
International non-proprietary name (INN) or common name
posaconazole
Therapeutic area (MeSH)
Mycoses
Anatomical therapeutic chemical (ATC) code
J02AC04
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
25/07/2019
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

25/07/2019 Posaconazole AHCL - EMEA/H/C/005028 -

Contents

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Pharmacotherapeutic group

ANTIMYCOTICS FOR SYSTEMIC USE

Therapeutic 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.

Assessment history

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