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.

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

arrotex pharmaceuticals pty ltd - posaconazole, quantity: 40 mg/ml - oral liquid, suspension - excipient ingredients: purified water; xanthan gum; peg-40 hydrogenated castor oil; liquid glucose; sodium citrate dihydrate; citric acid monohydrate; titanium dioxide; glycerol; sodium benzoate; 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - posaconazole - gastro-resistant tablet - 100 milligram(s) - triazole derivatives; posaconazole

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - posaconazole - gastro-resistant tablet - 100 milligram(s) - triazole derivatives; posaconazole

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

amneal pharmaceuticals ny llc - 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 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 delayed-release tablets are contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant administration of posaconazole

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

avkare - 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 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 delayed-release tablets are contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant

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

dr.reddys laboratories 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 chemotherap y [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 delayed-release tablets are contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole delayed-release tablets are contraindicated wit