Posaconazole SP
Lapsed
This medicine's authorisation has lapsed
posaconazole
MedicineHumanLapsed
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 25 October 2005, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Posaconazole SP (posaconazole), indicated for use in the treatment of fungal infections in adults (invasive aspergillosis, fusariosis, chromoblastomycosis and mycetoma, coccidioidomycosis and oropharyngeal candidiasis), and for prophylaxis of invasive fungal infections in patients receiving remission-induction chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes, and in hematopoietic stem cell transplant.
Posaconazole SP (posaconazole) had not been marketed in Europe since this initial marketing authorisation. In accordance with article 14(4) of Regulation (EC) No 726/2004 ('sunset clause'), the marketing authorisation of a medicinal product lapses if the product has never been marketed in one of the Member States within three years of its initial authorisation, calculated from the entry into force of the Regulation (20 November 2005) for products authorised before this date. Because of this, from 20 November 2008, the marketing authorisation for Posaconazole SP is no longer valid. Noxafil (posaconazole) is an identical product authorised in the EU.
Pursuant to the expiry of the marketing authorisation, the European Assessment Report (EPAR) for Posaconazole SP is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0011
04/12/2008
This medicine’s product information is available in all official EU languages.
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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).
Product details
- Name of medicine
- Posaconazole SP
- 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
Pharmacotherapeutic group
Antimycotics for systemic useTherapeutic indication
Posaconazole SP 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.
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 SP 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.
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