האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

novartis europharm limited - amlodipin, валсартан, hidroklorotiazid - hipertenzija - antagonisti angiotenzina ii u kombinaciji, agenti koji djeluju na ренин-ангиотензиновую sustav, antagonisti angiotenzina ii i antagonisti kalcija - liječenje esencijalne hipertenzije kao zamjena terapija u odraslih bolesnika čiji krvni tlak odgovarajuće kontroliran na kombinaciji amlodipin, valsartan i hidroklorotiazid (hct), uzeti kao tri pojedinačnih formulacije ili je dvojan-komponenta i pojedinačnih formulacija.

האיחוד האירופי - קרואטית - 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.

האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

genzyme europe bv - sevelamer hidroklorid - hyperphosphatemia; renal dialysis - svi ostali terapeutski proizvodi - tasermititet je indiciran za kontrolu hiperfosfatemije u odraslih bolesnika koji primaju hemodijalizu ili peritonealnu dijalizu. sevelamer hidroklorida treba koristiti u kontekstu više terapijskih pristupa, koji mogu uključivati kalcij dodataka, 1,25 dihidroksi vitamina d3 ili jedan od svojih analoga kontrolirati razvoj bolesti bubrega kostiju.

קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

pfizer croatia d.o.o., slavonska avenija 6, zagreb, hrvatska - metilprednizolon - tableta - 16 mg - urbroj: jedna tableta sadrži 16 mg metilprednizolona

קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

pfizer croatia d.o.o., slavonska avenija 6, zagreb, hrvatska - metilprednizolon - tableta - 32 mg - urbroj: jedna tableta sadrži 32 mg metilprednizolona

קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

pfizer croatia d.o.o., slavonska avenija 6, zagreb, hrvatska - metilprednizolon - tableta - 4 mg - urbroj: jedna tableta sadrži 4 mg metilprednizolona

קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

fresenius medical care hrvatska d.o.o., savska opatovina 36, zagreb, hrvatska - natrijev klorid kalcijev klorid dihidrat magnezijev klorid heksahidrat natrijev laktat, otopina glukoza hidrat - otopina za peritonejsku dijalizu - 5,786 g + 0,1838 g + 0,1017 g + 7,85 g + 16,50 g/1000 ml - urbroj: 1000 ml otopine sadrži 5,786 g natrijeva klorida, 0,1838 g kalcijeva klorid dihidrata, 0,1017 g magnezijeva klorid heksahidrata, 7,85 g otopine natrijeva laktata i 16,50 g glukoza hidrata

קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

fresenius medical care hrvatska d.o.o., savska opatovina 36, zagreb, hrvatska - natrijev klorid kalcijev klorid dihidrat magnezijev klorid heksahidrat natrijev laktat, otopina glukoza hidrat - otopina za peritonejsku dijalizu - 5,786 g + 0,1838 g + 0,1017 g + 7,85 g + 46,75 g/1000 ml - urbroj: 1000 ml otopine sadrži 5,786 g natrijeva klorida, 0,1838 g kalcijeva klorid dihidrata, 0,1017 g magnezijeva klorid heksahidrata, 7,85 g otopine natrijeva laktata i 46,75 g glukoza hidrata

קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

fresenius medical care hrvatska d.o.o., savska opatovina 36, zagreb, hrvatska - natrijev klorid kalcijev klorid dihidrat magnezijev klorid heksahidrat natrijev laktat, otopina glukoza hidrat - otopina za peritonejsku dijalizu - 5,786 g + 0,1838 g + 0,1017 g + 7,85 + 25,00 g/1000 ml - urbroj: 1000 ml otopine sadrži 5,786 g natrijeva klorida, 0,1838 g kalcijeva klorid dihidrata, 0,1017 g magnezijeva klorid heksahidrata, 7,85 g otopine natrijeva laktata i 25,00 g glukoza hidrata

קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

pfizer croatia d.o.o., slavonska avenija 6, zagreb, hrvatska - metilprednizolonacetat - suspenzija za injekciju - 40 mg/ml - urbroj: jedna bočica (1 ml) sadrži 40 mg metilprednizolonacetata