Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

remedia d.o.o. sarajevo - simoktokog alfa - prašak i rastvarač za rastvor za injekciju - 250 i.j./1 bočica - 1 bočica praška za rastvor za injekciju sadrži: 250 i.j. humani faktor koagulacije viii (rdnk), simoktokog alfa (100 i.j. / ml nakon rekonstitucije)

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

remedia d.o.o. sarajevo - simoktokog alfa - prašak i rastvarač za rastvor za injekciju - 2000 i.j./1 bočica - 1 bočica sa praškom za rastvor za injekciju sadrži: 2000 i.j. humanog faktora koagulacije viii (rdnk), simoktokog alfa (800 i.j./ml nakon rekonstitucije)

Crna Gora - hrvatski - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"medica" d.o.o. za proizvodnju, trgovinu na veliko i malo, export-import, podgorica - proteini plazme, humani - rastvor za infuziju - 45-70mg/ml

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz gmbh - rituksimab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antineoplastična sredstva - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. postoje samo ograničeni podaci o učinkovitosti i sigurnosti bolesnika prethodno liječenih monoklonsko antitijelo, uključujući rituksimab ili bolesne, vatrostalne standardnim tretmanima na prethodnu rituksimab + kemoterapija. cm. odjeljak 5. 1 za daljnje informacije. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituksimab je pokazala da smanjuje brzinu progresije oštećenja zglobova kao što se mjeri x-ray i poboljšati fizičku funkciju, prilikom raspoređivanja u kombinaciji s metotreksatom. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

octapharma (ip) sprl, allee de la recherche 65, anderlecht, belgija - адррес proteini ljudske plazme koji djeluju protiv inhibitora koagulacijskog faktora viii u - otopina za infuziju - 45-70 mg/ml - urbroj: 1 ml otopine za infuziju sadrži 45-70 mg proteina ljudske plazme

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

jana pharm d.o.o., lopašićeva 6, zagreb, hrvatska - koagulacijski faktor viii, ljudski - prašak i otapalo za otopinu za injekciju - 1000 iu/bočici - urbroj: svaka bočica nominalno sadrži 1000 iu ljudskog koagulacijskog faktora viii

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

jana pharm d.o.o., lopašićeva 6, zagreb, hrvatska - koagulacijski faktor viii, ljudski - prašak i otapalo za otopinu za injekciju - 250 iu/bočici - urbroj: svaka bočica nominalno sadrži 250 iu ljudskog koagulacijskog faktora viii

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

jana pharm d.o.o., lopašićeva 6, zagreb, hrvatska - koagulacijski faktor viii, ljudski - prašak i otapalo za otopinu za injekciju - 500 iu/bočici - urbroj: svaka bočica nominalno sadrži 500 iu ljudskog koagulacijskog faktora viii

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

octapharma (ip) sprl, allee de la recherche 65, anderlecht, belgija - ljudska plazma - prašak i otapalo za otopinu za infuziju - urbroj: jedna bočica s praškom sadrži 9 - 14 g proteina ljudske plazme specifičnih za krvne grupe ab0. nakon rekonstitucije sa 190 ml otapala, otopina sadrži 45-70 mg/ml proteina ljudske plazme specifičnih za krvne grupe ab0

Europska Unija - hrvatski - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hidroklorid - kolorektalne neoplazme - antineoplastična sredstva - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.