România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

gilead sciences ireland uc - irlanda - amphotericinum b - conc. pt. dispersie perf.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

gilead sciences ireland uc - irlanda - amphotericinum b - pulb. pt. conc. pt. dispersie perf. - antimicotice de uz sistemic

Uniunea Europeană - română - EMA (European Medicines Agency)

merck sharp and dohme b.v - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimicotice pentru uz sistemic - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 și 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 și 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. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. 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 și 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 și 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 și 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. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. 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 și 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 și 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. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. 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):- aspergiloză invazivă la pacienții cu boală rezistentă la amfotericina b sau itraconazol sau la pacienți care nu tolerează aceste medicamente;- fuzarioză la pacienții cu boală rezistentă la amfotericina b sau itraconazol sau la pacienți care nu tolerează amfotericina b;- cromoblastomicoză și micetom la pacienții cu boală rezistentă la itraconazol sau la pacienți care prezintă intoleranță la itraconazol;- coccidioidomicoză la pacienții cu boală rezistentă la amfotericina b, itraconazol sau fluconazol sau la pacienții care au intoleranță la aceste medicamente;- candidoza oro-faringiană: ca terapie de prima linie la pacienții care au boli grave sau sunt imunocompromiși, în care, ca răspuns la terapia topică este de așteptat să fie săraci. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. 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.

Uniunea Europeană - română - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazol - micozele - antimicotice pentru uz sistemic - posaconazole accord is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis;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. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. posaconazole accord este, de asemenea, indicat pentru profilaxia infecțiilor fungice sistemice la următorii pacienți: pacienții care au primit iertarea-chimioterapie de inducție pentru leucemie mieloidă acută (lma) sau în sindroamele mielodisplazice (smd) de așteptat apariția neutropeniei prelungite și care prezintă un risc ridicat de a dezvolta infecții fungice invazive;transplant de celule stem hematopoietice (tcsh) beneficiarii care sunt în curs de doze mari de terapie imunosupresoare pentru boala grefă contra gazdă și care sunt la risc ridicat de a dezvolta infecții fungice invazive.

Uniunea Europeană - română - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimicotice pentru uz sistemic - 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 seven 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.

Uniunea Europeană - română - EMA (European Medicines Agency)

schering-plough europe - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimicotice pentru uz sistemic - posaconazol sp este indicat pentru utilizarea în tratamentul următoarelor infecții fungice la adulți (vezi secțiunea 5. 1):- aspergiloză invazivă la pacienții cu boală rezistentă la amfotericina b sau itraconazol sau la pacienți care nu tolerează aceste medicamente;- fuzarioză la pacienții cu boală rezistentă la amfotericina b sau itraconazol sau la pacienți care nu tolerează amfotericina b;- cromoblastomicoză și micetom la pacienții cu boală rezistentă la itraconazol sau la pacienți care prezintă intoleranță la itraconazol;- coccidioidomicoză la pacienții cu boală rezistentă la amfotericina b, itraconazol sau fluconazol sau la pacienții care au intoleranță la aceste medicamente;- candidoza oro-faringiană: ca terapie de prima linie la pacienții care au boli grave sau sunt imunocompromiși, în care, ca răspuns la terapia topică este de așteptat să fie săraci. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. posaconazole sp este, de asemenea, indicat pentru profilaxia infecțiilor fungice sistemice la următorii pacienți:- pacienți care primesc iertarea-chimioterapie de inducție pentru leucemie mieloidă acută (lma) sau în sindroamele mielodisplazice (smd) de așteptat apariția neutropeniei prelungite și care areat risc ridicat de a dezvolta infecții fungice invazive;- transplant de celule stem hematopoietice (tcsh) beneficiarii care sunt în curs de doze mari de terapie imunosupresoare pentru boala grefă contra gazdă și care sunt la risc ridicat de a dezvolta infecții fungice invazive.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

zentiva s.a. - romania - voriconazolum - compr. film. - 200mg - antimicotice de uz sistemic derivati de triazol

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

anfarm hellas s.a. - grecia - voriconazolum - pulb. pt. sol. perf. - 200mg - antimicotice de uz sistemic derivati de triazol

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

rompharm company s.r.l. - romania - voriconazolum - pulb. pt. conc. pt. sol. perf. - 200mg - antimicotice de uz sistemic derivati de triazol

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

rompharm company s.r.l. - romania - ganciclovirum - pulb. pt. conc. pt. sol. perf. - 500mg - antivirale cu actiune directa nucleozide & nucleotide excl inhib. si reverstranscriptei