Posaconazole Accord
posaconazole
Table of contents
Overview
Posaconazole Accord 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 Accord 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 Accord contains the active substance posaconazole and is a ‘generic medicine’. This means that Posaconazole Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Noxafil.
For more information on generic medicines, see the question-and-answer document below.
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Posaconazole Accord : EPAR - Medicine overview (PDF/200.98 KB)
First published: 28/08/2019
EMA/320670/2019 -
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Posaconazole Accord : EPAR - Risk-management-plan summary (PDF/116.74 KB)
First published: 28/08/2019
Authorisation details
| Product details | |
|---|---|
| Name |
Posaconazole Accord
|
| Agency product number |
EMEA/H/C/005005
|
| Active substance |
posaconazole
|
| International non-proprietary name (INN) or common name |
posaconazole
|
| Therapeutic area (MeSH) |
Mycoses
|
| Anatomical therapeutic chemical (ATC) code |
J02AC04
|
Generic |
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.
|
| Revision |
7
|
| Date of issue of marketing authorisation valid throughout the European Union |
25/07/2019
|
| Contact address |
Accord Healthcare S.L.U. |
Product information
16/12/2022 Posaconazole Accord - EMEA/H/C/005005 - IA/0011
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antimycotics for systemic use
Therapeutic indication
Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults:
- 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.
Posaconazole Accord 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.