Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

animedica gmbh (8031253) - all-rac-alpha-tocopherolacetat (ph.eur.); retinolpalmitat; colecalciferol - injektionslösung - all-rac-alpha-tocopherolacetat (ph.eur.) (00328) 50 milligramm; retinolpalmitat (00832) 176,47 milligramm; colecalciferol (00615) 2,5 milligramm - ferkel; rind; schwein; ziege; schaf; hund; pferd

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

bela-pharm gmbh & co.kg (3072170) - all-rac-alpha-tocopherolacetat (ph.eur.); Ölige lösungen von colecalciferol; Ölige lösung von synthetischem vitamin a ((mindestens 500 000 ie vitamin a je gramm)) - emulsion - all-rac-alpha-tocopherolacetat (ph.eur.) (00328) 30 milligramm; Ölige lösungen von colecalciferol (00369) 5 milligramm; Ölige lösung von synthetischem vitamin a ((mindestens 500 000 ie vitamin a je gramm)) (00335) 20 milligramm - pferd; huhn; schwein; rind

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

serumwerk bernburg ag (4020169) - retinolpalmitat; colecalciferol; all-rac-alpha-tocopherolacetat (ph.eur.); ascorbinsäure - lösung - retinolpalmitat (00832) 30 milligramm; colecalciferol (00615) 0,125 milligramm; all-rac-alpha-tocopherolacetat (ph.eur.) (00328) 30 milligramm; ascorbinsäure (00040) 100 milligramm - taube; schwein; katze; kalb; kaninchen; schaf; huhn; hund; gans; ziege; nerz; pferd; wachtel; truthuhn; ente; strauß

Austria - Jerman - AGES (Agentur für Gesundheit und Ernährungssicherheit)

gilvasan pharma gmbh - heparin natrium - heparin group

Austria - Jerman - AGES (Agentur für Gesundheit und Ernährungssicherheit)

zoetis Österreich gmbh - alpha-tocopherolacetat; colecalciferol; retinol propionat -

Austria - Jerman - AGES (Agentur für Gesundheit und Ernährungssicherheit)

medicamentum pharma gmbh - heparin natrium -

Austria - Jerman - AGES (Agentur für Gesundheit und Ernährungssicherheit)

medicamentum pharma gmbh - heparin natrium -

Austria - Jerman - AGES (Agentur für Gesundheit und Ernährungssicherheit)

chanelle pharmaceuticals manufacturing limited - pentobarbital natrium -

Uni Eropa - Jerman - 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.

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

bela-pharm gmbh & co.kg (3072170) - retinolpalmitat; Ölige lösungen von colecalciferol; all-rac-alpha-tocopherolacetat (ph.eur.) - injektionslösung - retinolpalmitat (00832) 176,46 milligramm; Ölige lösungen von colecalciferol (00369) 100 milligramm; all-rac-alpha-tocopherolacetat (ph.eur.) (00328) 50 milligramm - pferd; rind; hund; schwein