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

arrotex pharmaceuticals pty ltd - posaconazole, quantity: 40 mg/ml - oral liquid, suspension - excipient ingredients: sodium benzoate; sodium citrate dihydrate; citric acid monohydrate; titanium dioxide; glycerol; xanthan gum; liquid glucose; peg-40 hydrogenated castor oil; purified water; peg-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid; flavour - 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 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.

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

teva b.v. - posaconazole - gastro-resistant tablet - 100 milligram(s) - posaconazole

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 10787-33 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.

United States - English - NLM (National Library of Medicine)

par pharmaceutical inc. - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. posaconazole is indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus-host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.1)] as follows: - posaconazole delayed-release tablets : adults and pediatric patients 2 years of age and older who weigh greater than 40 kg - posaconazole oral suspension: adults and pediatric patients 13 years of age and older posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and o

New Zealand - English - Medsafe (Medicines Safety Authority)

juno pharmaceuticals nz limited - posaconazole 100mg;   - modified release tablet - 100 mg - active: posaconazole 100mg   excipient: colloidal silicon dioxide croscarmellose sodium hyprolose methacrylic acid - ethyl acrylate copolymer microcrystalline cellulose opadry yellow 85f520152 propyl gallate sodium stearyl fumarate triethyl citrate xylitol - posaconazole juno 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. - oesophageal candidiasis or candidemia in patients with disease that is refractory to, or who are intolerant of, amphotericin b, fluconazole, or itraconazole. - fusariosis, zygomycosis, cryptococcosis, chromoblastomycosis, and mycetoma in patients with disease refractory to other therapy, or patients who are intolerant of other therapy. - coccidioidomycosis posaconazole juno is also indicated for the prophylaxis of invasive fungal infections, including both yeasts and moulds, in 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.

United States - English - NLM (National Library of Medicine)

biocon phama inc. - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole delayed-release tablets are indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus- host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.2) ] as follows • posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older. additional pediatric use information is approved for merck sharp & dohme corp.’s noxafil (posaconazole delayed-release tablets). however, due to merck sharp & dohme corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant administration of posaconazo

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