Posaconazole

Active substance
Posaconazole
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Generic
Main indication
Other infectious diseases
Extended indication
Posaconazole AHCL is indicated for 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 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.

1. Product

Current proprietary name
Noxafil (MSD)
Proprietary name
Posaconazole AHCL
Manufacturer
Accord Healthcare
Mechanism of action
Antifungals
Additional comments
Dit betreft 1 van de twee generieken voor posaconazole die is opgenomen in de Horizonscan.

2. Registration

Registration route
Centralised (EMA)
Expected Registration
July 2019
Orphan drug
No
Registration phase
Registered
Additional comments
SPC Noxafil verloopt op 19 december 2019. Positieve CHMP-opinie mei 2019. Geregistreerd in juli 2019.

3. Therapeutic value

Therapeutic value
Potential equal value
Duration of treatment
Not found

4. Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

5. Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

6. Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.