Europos Sąjunga - kroatų - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotika za sustavnu uporabu - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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.

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

remedica ltd., aharnon street, limassol industrial estate, limassol, cipar - emtricitabin tenofovirdizoproksilsukcinat - filmom obložena tableta - 200 mg + 245 mg - urbroj: jedna filmom obložena tableta sadrži 200 mg emtricitabina i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilsukcinata)

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

medochemie ltd., constatinoupoleos str. 1-10, limassol, cipar - duloksetinklorid - želučanootporna kapsula, tvrda - 60 mg - urbroj: jedna kapsula sadrži 60 mg duloksetina (u obliku klorida)

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

medochemie ltd., constatinoupoleos str. 1-10, limassol, cipar - vorikonazol - filmom obložena tableta - 200 mg - urbroj: svaka tableta sadrži 200 mg vorikonazola

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

medochemie ltd., constatinoupoleos str. 1-10, limassol, cipar - vorikonazol - filmom obložena tableta - 50 mg - urbroj: svaka tableta sadrži 50 mg vorikonazola

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

medochemie ltd., constatinoupoleos str. 1-10, limassol, cipar - aripiprazol - tableta - 10 mg - urbroj: svaka tableta sadrži 10 mg aripiprazola

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

medochemie ltd., constatinoupoleos str. 1-10, limassol, cipar - aripiprazol - tableta - 15 mg - urbroj: svaka tableta sadrži 15 mg aripiprazola

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

medochemie ltd., constatinoupoleos str. 1-10, limassol, cipar - linezolid - filmom obložena tableta - 600 mg - urbroj: svaka tableta sadrži 600 mg linezolida

Kroatija - kroatų - HALMED (Agencija za lijekove i medicinske proizvode)

medochemie ltd., constatinoupoleos str. 1-10, limassol, cipar - ceftriaksonnatrij - prašak za otopinu za injekciju / infuziju - 1g/bočica - urbroj: 1 bočica s praškom za otopinu za injekciju/infuziju sadrži 1 g ceftriaksona u obliku ceftriaksonnatrija

Europos Sąjunga - kroatų - EMA (European Medicines Agency)

accord healthcare s.l.u. - финголимод hidroklorid - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivima selektivni imunosupresivima - istaknuo kao jedan bolest модифицирующей terapije kod visoke aktivnosti relapsing ublažavanje multiplom sklerozom za sljedećih skupina odraslih pacijenata i pedijatrijska bolesnika u dobi od 10 godina i stariji:pacijenti sa visokom aktivnošću bolesti, unatoč potpun i adekvatan tretman sa najmanje jednim bolest дорабатывая therapyorpatients s brzo razvija težak relapsing ublažavanje multiplom sklerozom određuje se 2 ili više teških recidiva u roku od jedne godine, s 1 ili više gadolinij revitalizacije lezija na mr mozga ili značajno povećanje u t2 leglo opterećenja u usporedbi s posljednjim mr.