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

berlin chemie / menarini bh d.o.o. sarajevo - pankreatin - želučanootporna tableta - 160 mg/1 tableta 222,22 mg/1 tableta - 1 želučanootporna tableta sadrži 160 mg 222,22 mg pancreas praška sa minimalnom aktivnosti: lipaza 20 000 ph.eur. jedinica; amilaza 12 000 ph.eur. jedinica; proteaza 900 ph.eur. jedinica

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

berlin-chemie menarini hrvatska d.o.o., horvatova 80a, zagreb, hrvatska - gušterača, prašak - želučanootporna kapsula, tvrda - najmanje 10 000 ph. eur. jedinica lipolitičke aktivnosti / kapsuli - urbroj: jedna tvrda kapsula sa želučanootpornim minitabletama sadrži 153,5 mg praška gušterače što odgovara najmanje 10 000 ph. eur. jedinica lipolitičke aktivnosti, 9 000 ph. eur. jednica amilolitičke aktivnosti i 500 ph. eur. jedinica proteolitičke aktivnosti

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

berlin-chemie menarini hrvatska d.o.o., horvatova 80a, zagreb, hrvatska - gušterača, prašak - želučanootporna kapsula, tvrda - najmanje 25 000 ph. eur. jedinica lipolitičke aktivnosti/kapsuli - urbroj: jedna tvrda kapsula sa želučanootpornim minitabletama sadrži 356,1 mg praška gušterače što odgovara najmanje 25 000 ph. eur. jedinica lipolitičke aktivnosti, 22 500 ph. eur. jednica amilolitičke aktivnosti i 1250 ph. eur. jedinica proteolitičke aktivnosti

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

bosnalijek d.d. - okskarbazepin - tableta - 600 mg/1 tableta - 1 tableta sadrži: 600 mg okskarbazepina

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

bosnalijek d.d. - okskarbazepin - tableta - 300 mg/1 tableta - 1 tableta sadrži: 300 mg okskarbazepina

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti. .

Europska Unija - hrvatski - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. iskustvo s иматинибом u bolesnika s mds/rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen. nema kontroliranih istraživanja pokazuju kliničku korist ili povećanje preživljavanja za te bolesti.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viatris healthcare limited - tolkapon - parkinsonova bolest - anti-parkinsonove bolesti lijekovima, drugim дофаминергических posrednika - tasmar je indiciran u kombinaciji s levodopom / benserazide ili levodope / carbidopa bolesnicima s levodope reagira idiopatske parkinsonove bolesti i motoričke fluktuacije, koji nisu ili se ne podnose druge catechol-o-methyltransferase (comt) inhibitori. zbog rizika od potencijalno smrtonosne, akutnog oštećenja jetre, tasmar ne treba shvatiti kao prizemlju, kuhinju, blagovaonu-linija terapije za леводопы / бенсеразида ili леводопы / карбидопы. s tasmar treba koristiti samo u kombinaciji s lijekovima леводопы / бенсеразида i леводопы / карбидопы da se informacije o učinku tih lijekova леводопы i odnosi se na njihova istodobna primjena s tasmar.

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

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - okskarbazepin - filmom obložena tableta - 300 mg - urbroj: jedna filmom obložena tableta sadrži 300 mg okskarbazepina