Euroopa Liit - horvaadi - EMA (European Medicines Agency)

zentiva, k.s. - duloksetin - neuralgia; depressive disorder, major; anxiety disorders; diabetes mellitus - ostali antidepresivi - liječenje depresivnog poremećaja, dijabetička neuropatska bol, poremećaj anksioznosti. setin Зентива navodi u odraslih.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

pierre fabre medicament - vinorelbin - carcinoma, transitional cell; urologic neoplasms - antineoplastična sredstva - javlor je indiciran u monoterapiji za liječenje odraslih bolesnika s naprednim ili metastatskim karcinomom prijelazne stanice urotelijalnog trakta nakon neuspjeha prethodnog režima koji sadrži platinu. učinkovitost i sigurnost винфлунин nije studirao kod pacijenata s pokazateljima stanja ≥ 2.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

hra pharma rare diseases - ketokonazolom - cushingov sindrom - antimikotika za sustavnu uporabu - ketokonazol hra je indiciran za liječenje endogenog cushingovog sindroma u odraslih i adolescenata starijih od 12 godina.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - pramipeksol dihidroklorid monohidrat - restless legs syndrome; parkinson disease - antiparkinsonski lijekovi - mirapexin je indiciran za liječenje znakova i simptoma idiopatske parkinsonove bolesti, (bez levodope) ili u kombinaciji s levodopom, ja. tijekom tijeka bolesti, do kasnih faza, kada učinak levodope nestaje ili postaje nedosljedan i dolazi do fluktuacija terapeutskog učinka (kolebljivost na kraju doze ili "on-off"),. mirapexin indiciran za simptomatsko liječenje umjerene do teške idiopatskom sindrom nemirnih nogu u dozama do 0. 54 mg (0. 75 mg soli).

Euroopa Liit - horvaadi - 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.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

eli lilly nederland b.v. - duloksetin hidroklorid - urinarnu inkontinenciju, stres - psychoanaleptics, - yentreve je indiciran za žene u liječenju umjerene do teške stresne inkontinencije (sui).

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

teva pharma b.v. - pramipeksol dihidroklorid monohidrat - parkinsonova bolest - antiparkinsonski lijekovi - pramipexol teva je indiciran za liječenje znakova i simptoma idiopatske parkinsonove bolesti, samostalno (bez levodope) ili u kombinaciji s levodopom, i. tijekom tijeka bolesti, do kasnih faza, kada učinak levodope nestaje ili postaje nedosljedan i dolazi do fluktuacija terapeutskog učinka (kolebljivost na kraju doze ili "on-off"),. Прамипексол tewa prikazan kod odraslih za simptomatsko liječenje umjerene do teške idiopatska sindrom nemirnih nogu u dozama do 0. 54 mg (0. 75 mg soli) (vidi odjeljak 4.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

esteve pharmaceuticals, s.a. - duloksetin - anxiety disorders; depressive disorder, major; diabetic neuropathies - psychoanaleptics, - liječenje velikog depresivnog poremećaja;liječenje dijabetičke periferne neuropatske boli;liječenje generalizirani anksiozni poremećaj;baikal je navedeno u odraslih.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

krka, d.d., novo mesto - pramipeksol dihidroklorid monohidrat - parkinsonova bolest - antiparkinsonski lijekovi - oprymea je indiciran za liječenje znakova i simptoma idiopatske parkinsonove bolesti, (bez levodope) ili u kombinaciji s levodopom, ja. u roku od bolesti do kasnijim fazama, kada je učinak леводопы istroši ili je nedosljedan i fluktuacije terapijskog efekta (kraj dozu ili "on off" oscilacije). oprymea prikazan kod odraslih za simptomatsko liječenje umjerene do teške idiopatska sindrom nemirnih nogu u dozama do 0. 54 mg (0. 75 mg soli) (vidi odjeljak 4.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipeksol dihidroklorid monohidrat - parkinson disease; restless legs syndrome - antiparkinsonski lijekovi - pramipeksol accord je indiciran u odraslih za liječenje znakova i simptoma idiopatske parkinsonove bolesti, (bez levodope) ili u kombinaciji s levodopom, ja. tijekom tijeka bolesti, do kasnih faza, kada učinak levodope nestaje ili postaje nedosljedan i dolazi do fluktuacija terapeutskog učinka (kolebljivost na kraju doze ili "on-off"),.