Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; triethyl citrate; microcrystalline cellulose; croscarmellose sodium; propyl gallate; methacrylic acid - ethyl acrylate copolymer (1:1); xylitol; sodium stearylfumarate; hyprolose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - posaconazole juno is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.,? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.,posaconazole juno is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: croscarmellose sodium; macrogol 400; hypromellose acetate succinate; silicon dioxide; triacetin; purified talc; hyprolose; iron oxide red; magnesium stearate; titanium dioxide; microcrystalline cellulose; hypromellose - posaconazole dr.reddy's (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ,? invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ,? fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. ,posaconazole dr.reddy's is also indicated for the: ,? prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

European Union - English - EMA (European Medicines Agency)

schering-plough europe - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotics for systemic use - 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 areat 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.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazole - mycoses - antimycotics for systemic use - 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.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazole - mycoses - antimycotics for systemic use - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

devatis limited - posaconazole 40 mg/ml ((form-1)) - oral suspension - 40 mg/ml - active: posaconazole 40 mg/ml ((form-1)) excipient: cherry flavour 20358305 (100580607) citric acid monohydrate glucose liquid glycerol polysorbate 80 simethicone emulsion usp sodium benzoate sodium citrate titanium dioxide xanthan gum - posaconazole oral suspension is indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older: - invasive aspergillosis in patients with disease that is refractory to, or are intolerant of, amphotericin b, itraconazole or voriconazole.

Malta - English - Medicines Authority

clonmel healthcare limited waterford road, clonmel, co. tipperary e91 d768, ireland - posaconazole - gastro-resistant tablet - posaconazole 100 mg - antimycotics for systemic use

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - posaconazole, quantity: 300 mg - injection, concentrated - excipient ingredients: sulfobutyl betadex sodium; disodium edetate; hydrochloric acid; sodium hydroxide; water for injections - noxafil (posaconazole) concentrated injection is indicated for use in the treatment of the following invasive fungal infections in adults: invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. noxafil is also indicated for the: prophylaxis of invasive fungal infections among adults, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: hypromellose acetate succinate; microcrystalline cellulose; hyprolose; silicon dioxide; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - noxafil (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older; invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy; fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. noxafil is also indicated for the: treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. prophylaxis of invasive fungal infections, among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - posaconazole, quantity: 40 mg/ml - suspension - excipient ingredients: sodium benzoate; liquid glucose; titanium dioxide; polysorbate 80; xanthan gum; purified water; sodium citrate dihydrate; glycerol; simethicone; citric acid monohydrate; flavour - noxafil (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older; invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy; fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. noxafil is also indicated for the: treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole.prophylaxis of invasive fungal infections, among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.