סינגפור - אנגלית - HSA (Health Sciences Authority)

sandoz singapore pte. ltd. - posaconazole - tablet, delayed release - posaconazole 100.00 mg

בנגלדש - אנגלית - DGDA (Directorate General of Drug Administration)

advanced chemical industries limited - posaconazole - tablet - 100 mg

אוסטרליה - אנגלית - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - posaconazole - unknown - posaconazole antifungal active 0.0 - active constituent

מלזיה - אנגלית - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dr. reddy`s laboratories malaysia sdn. bhd. - posaconazole -

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - posaconazole 18 mg/ml;   - concentrate for injection - 300mg/16.7ml - active: posaconazole 18 mg/ml   excipient: disodium edetate hydrochloric acid sodium hydroxide sulfobutyl betadex sodium water for injection - 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.

סינגפור - אנגלית - HSA (Health Sciences Authority)

kingtop international trading pte ltd - posaconazole - tablet, delayed release - posaconazole 100 mg

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

dr reddy's new zealand limited - posaconazole 100mg - modified release tablet - 100 mg - active: posaconazole 100mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose acetate succinate isopropyl alcohol magnesium stearate microcrystalline cellulose opadry brown 03b565138 opadry clear 03k19229 purified water   - 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. " esophageal 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. indicated for use as: " 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 hematopoietic stem cell transplant (hsct) recipients.

ישראל - אנגלית - Ministry of Health

merck sharp & dohme israel ltd - posaconazole - concentrate for solution for infusion - posaconazole 300 mg/vial - posaconazole - noxafil concentrate for solution for infusion 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.- zygomycosis, in patients intolerant of, or with disease that is refractory to, alternative therapy.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 f

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - posaconazole 40 mg/ml - oral suspension - 40 mg/ml - active: posaconazole 40 mg/ml excipient: cherry flavour 13174 citric acid monohydrate glucose liquid glycerol polysorbate 80 purified water simeticone sodium benzoate sodium citrate dihydrate titanium dioxide xanthan gum

האיחוד האירופי - אנגלית - 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.