Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

alfred e. tiefenbacher (gmbh & co. kg) (8016331) - posaconazol - magensaftresistente tablette - teil 1 - magensaftresistente tablette; posaconazol (29576) 100 milligramm

Europäische Union - Deutsch - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykotika zur systemischen anwendung - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 und 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 und 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. feuerfestigkeit ist definiert als progression der infektion oder misserfolg zu verbessern, nachdem mindestens 7 tage vor der therapeutischen dosen der wirksamen antimykotischen therapie. 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 und 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 und 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 und 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. feuerfestigkeit ist definiert als progression der infektion oder misserfolg zu verbessern, nachdem mindestens 7 tage vor der therapeutischen dosen der wirksamen antimykotischen therapie. 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 und 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 und 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. feuerfestigkeit ist definiert als progression der infektion oder misserfolg zu verbessern, nachdem mindestens 7 tage vor der therapeutischen dosen der wirksamen antimykotischen therapie. 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 aspergillose bei patienten mit der krankheit, die refraktär gegenüber amphotericin b oder itraconazol bzw. bei patienten, die intolerant sind gegenüber diesen arzneimitteln;- fusariosis bei patienten mit der krankheit, die refraktär gegenüber amphotericin b ist bzw. bei patienten, die intolerant sind gegenüber amphotericin b;- chromoblastomycosis und mycetoma bei patienten mit der krankheit, ist gegenüber itraconazol bzw. bei patienten, die intolerant sind gegenüber itraconazol;- coccidioidomycosis bei patienten mit der krankheit, die refraktär gegenüber amphotericin b, itraconazol oder fluconazol, oder bei patienten, die intolerant sind gegenüber diesen arzneimitteln;- oropharyngeale candidose: als first-line-therapie bei patienten, die eine schwere erkrankung oder ein geschwächtes immunsystem haben, in denen in reaktion auf eine topische therapie erwartet wird, arm zu sein. feuerfestigkeit ist definiert als progression der infektion oder misserfolg zu verbessern, nachdem mindestens 7 tage vor der therapeutischen dosen der wirksamen antimykotischen therapie. 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.

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

helvepharm ag - posaconazolum - magensaftresistente tablette - posaconazolum 100 mg, antiox.: e 310, excipiens pro compresso dunst. - pilzinfektionen - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

accord healthcare ag - posaconazolum - magensaftresistente tablette - posaconazolum 100 mg, acidi methacrylici und ethylis acrylatis polymerisatum 1:1, triethylis citras, xylitolum, hydroxypropylcellulosum, cellulosum microcristallinum, silica colloidalis anhydrica, carmellosum natricum nur zusammen gehalten, natrii stearylis fumaras, e 310, Überzug: poly(alkohol vinylicus), macrogolum 3350, talkum, e 171, e 172 (gelb), für compresso haze endwerte. natrium 1,25 mg. - pilzinfektionen - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

sandoz pharmaceuticals ag - posaconazolum - magensaftresistente tablette - posaconazolum 100 mg, antiox.: e 310, excipiens pro compresso dunst. - pilzinfektionen - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

viatris pharma gmbh - posaconazolum - magensaftresistente tablette - posaconazolum 100 mg, acidi methacrylici et ethylis acrylatis polymerisatum 1:1, triethylis citras, xylitolum, hydroxypropylcellulosum, e 310, cellulosum microcristallinum, silica colloidalis anhydrica, carmellosum natricum conexum, natrii stearylis fumaras, Überzug: poly(alcohol vinylicus), e 171, macrogolum 3350, talcum, e 172 (flavum), pro compresso obducto corresp. natrium 2.4 mg. - pilzinfektionen - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

accord healthcare ag - posaconazolum - suspension zum einnehmen - posaconazolum 200 mg, macrogolglyceroli hydroxystearas 25 mg, natrii citras dihydricus, acid citricum monohydricum, dimeticonum, silica colloidalis hydrica, methylcellulosum, säure sorbicum, polysorbatum 65, macrogoli stearas, xanthani kaugummi, traubenzucker-flüssigkeit, 1.75 g, glycerolum, säure benzoicum < 12 µg, säure sulfuricum, sind (erdbeeraroma), propylenglycolum 10.86 mg, e 171, e-211 11.4 mg, aqua purificata, um die suspension für 5 ml endwerte., natrium 2.52 mg. - antimykotikum - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

devatis ag - posaconazolum - suspension zum einnehmen - posaconazolum 200 mg, polysorbatum 80, xanthani gummi, natrii benzoas 10 mg, acidum citricum monohydricum, natrii citras dihydricus, glycerolum, glucosum liquidum 1750 mg, e 171, simeticonum, polysorbatum 65, methylcellulosum, macrogoli stearas, mono/diglycerida, e 200, e 210 0.045 mg, acidum sulfuricum, aromatica (kirschen) cum propylenglycolum 14.35 mg, aqua purificata ad suspensionem pro 5 ml corresp. natrium 3.4 mg. - pilzinfektionen - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

viatris pharma gmbh - posaconazolum - suspension zum einnehmen - posaconazolum 200 mg, acidum citricum monohydricum, natrii dihydrogenocitras anhydricus, natrii benzoas 10 mg, natrii laurilsulfas, simeticonum, methylcellulosum, acidum sorbicum, xanthani gummi, glycerolum, glucosum liquidum 2108.5 mg, e 171, aromatica (kirschen), aqua purificata ad suspensionem pro 5 ml corresp. natrium 5.91 mg. - pilzinfektionen - synthetika

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

1a pharma gmbh - posaconazol -