Malta - English - Medicines Authority

gilead sciences international limited - amphotericin b - powder for concentrate for dispersion for infusion - amphotericin b 50 mg - antimycotics for systemic use

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - amphotericin b - powder for concentrate for solution for infusion - amphotericin b 50 mg - antimycotics for systemic use

Kenya - English - Pharmacy and Poisons Board

samarth life sciences pvt ltd samarth life sciences pvt ltd - amphotericin b usp 50mg - injection - 50mg - amphotericin b

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - amphotericin b 100 mg/ml - oral suspension - 100 mg/ml - active: amphotericin b 100 mg/ml excipient: glycerol

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - amphotericin b 50mg (plus 2.5mg overage) - powder for injection - 50 mg - active: amphotericin b 50mg (plus 2.5mg overage) excipient: deoxycholic acid dibasic sodium phosphate dodecahydrate monobasic sodium phosphate dihydrate

India - English - Central Drugs Standard Control Organization

cipla - amphotericin-b - inj - 50mg(amphotericin en capsulated in liposomes) - 50mg

Ireland - English - HPRA (Health Products Regulatory Authority)

cephalon uk limited - amphotericin b - suspension for injection - 5 mg/ml

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - caspofungin acetate - candidiasis; aspergillosis - antimycotics for systemic use - treatment of invasive candidiasis in adult or paediatric patients.treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and/or itraconazole. 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.empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

European Union - English - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazole - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimycotics for systemic use - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4.2 and 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.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.noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 5.1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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.please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis. noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4.2 and 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.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.noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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 (gvhd) and who are at high risk of developing invasive fungal infections.please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis. noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4.2 and 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.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.noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic 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.please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis. noxafil oral suspension 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.noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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.please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. 

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

sun pharma anz pty ltd - fluconazole, quantity: 200 mg - capsule, hard - excipient ingredients: purified water; lactose monohydrate; maize starch; patent blue v; magnesium stearate; titanium dioxide; erythrosine; gelatin; colloidal anhydrous silica; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - ozole (fluconazole) capsules, given orally, are indicated for the following conditions: - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the acute phase of cryptococcal meningitis. - maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. - treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. - secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. - serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infecctions. until such data are available, amphotericin b remains the drug of choice. - vaginal candidiasis, when topical therapy has failed. - treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therpy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks.