Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

krka, d.d., novo mesto - rivastigmin - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - simptomatsko liječenje blage do umjereno teške alzheimerove demencije. simptomatsko liječenje blage do umjereno teške demencije kod pacijenata sa idiopatskom parkinsonovom bolešću.

Avrupa Birliği - Hırvatça - 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.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

gilead sciences ireland uc - эмтрицитабин, рилпивирин hidroklorid, Тенофовир alafenamide - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - odrasli i adolescenti (u dobi od 12 godina i stariji sa tjelesne težine najmanje 35 kg) zaraženih virusom humane imunodeficijencije (hiv-a 1) 1 bez poznatih mutacija povezanih s rezistencijom na sobe nukleozida inhibitora reverzne transkriptaze (nnrti) klasa, tenofovir ili emtricitabin i uz virusne opterećenja ≤ 100 000 hiv 1 rna kopija/ml.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

novartis europharm limited  - pazopanib - karcinom, stanice bubrega - antineoplastična sredstva - Почечно srpastih stanica karcinom Вотриент (ОКВ)navodi u odraslih za prvu liniju liječenja održao почечно-stanica raka (pkr) i za pacijente koji su primili do цитокиновой terapija u kasnijim fazama bolesti. sarkom mekog tkiva (its)Вотриент indiciran za liječenje odraslih bolesnika s selektivna podtipovi modernih sarkom mekog tkiva (smt), koji je dobio ranije kemoterapije za метастатической bolesti ili koji su napredovali u roku od 12 mjeseci nakon (neo)adjuvantne terapije. učinkovitost i sigurnost je samo u nekim СЦ гистологических podtipova tumora.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

teva b.v. - Триоксид arsen - leukemija, promyelocytic, akutna - antineoplastična sredstva - Тризенокс prikazan za indukciju remisije i konsolidacije kod odraslih pacijenata s je prvi put dijagnosticiran niski i srednji rizik od akutne промиелоцитарной leukemije (ОПЛ) (bijelih krvnih stanica ≤ 10 x 103/Μl) u kombinaciji s potpuno trans‑ретиноевая kiselina (ПТРК)relapsed/тугоплавким oštar промиелоцитарный leukemije (ОПЛ) (prethodni tretman treba da sadrže retinoid i kemoterapije), karakterizira t(15;17) translokacije i/ili dostupnost, ili za pro-myelocytic Лейков/ретиноевая-kiselina-receptor alfa (od pml/rar-alfa) gena. brzina reakcije druge akutne mijeloične podtipovi leukemije do триоксида arsen ne smatra.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

novartis europharm limited - rivastigmin - alzheimer disease; parkinson disease; dementia - psychoanaleptics, - simptomatsko liječenje blage do umjereno teške alzheimerove demencije. simptomatsko liječenje blage do umjereno teške demencije kod pacijenata sa idiopatskom parkinsonovom bolešću.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

actavis group ptc ehf - rivastigmin vodik tartarat - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - simptomatsko liječenje blage do umjereno teške alzheimerove demencije. simptomatsko liječenje blage do umjereno teške demencije kod pacijenata sa idiopatskom parkinsonovom bolešću.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirenz - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - stocrin je indiciran u antivirusnom kombiniranom tretmanu odraslih, adolescenata i djece starijih od tri godine starijih od ljudske imunodeficijencije-1 (hiv-1). Стокрин nisu bili pravilno istražena u bolesnika s uznapredovalom faze infekcije hiv-om, a upravo je u bolesnika s razinom cd4 < 50 ćelija/mm3, ili nakon neuspjeha протеаза-inhibitora (pi)-sadrže sheme. iako je cross-otpornost эфавиренза sa ip nije bio registriran, trenutno nema dovoljno podataka o efikasnosti kasniju upotrebu pi na temelju kombinirane terapije neučinkovitosti sheme sadrže Стокрин.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - anagrelide - trombocitemija, esencijalna - antineoplastična sredstva - xagrid je indiciran za smanjenje povišenih trombocita u rizičnih eterično-thrombocythaemia (et) bolesnika koji ne podnose da njihova trenutna terapija ili čiji povišenih trombocita ne umanjuju na prihvatljivu razinu njihove trenutne terapije. u grupu rizika patientan na rizik i određuje jedno ili više od sljedećeg:>60 godina;broj trombocita >1000 x 109/l;ili povijest događaja thrombohaemorrhagic .

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - kapecitabin - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastična sredstva - Кселода propisan za адъювантного liječenje bolesnika nakon operacije iii faze (dukes faza c) rak debelog crijeva . Кселода propisan za liječenje метастатического raka debelog crijeva . Кселода propisan za prva linija terapije popularnog raka želuca u kombinaciji s platinum temelju stanja. Кселода u kombinaciju sa docetaxel indiciran za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti цитотоксической kemoterapije. prethodna terapija mora sadržavati антрациклиновый. Кселода je također indiciran u monoterapiji za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti Таксанов i антрациклин sadrže načina kemoterapije ili za koje antikancerogena terapija nije naveden.