Europska Unija - hrvatski - EMA (European Medicines Agency)

koanaa healthcare gmbh - иматиниба мезилат - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastična sredstva - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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. pacijenti koji imaju niske ili vrlo nizak rizik od recidiva, ne bi trebali primati adjuvantne terapije. 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. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. 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)

viatris healthcare limited - fenofibrate, simvastatin - dislipidemije - sredstva za modifikaciju lipida - cholib je indiciran kao dodatna terapija dijeti i tjelovježbi u odraslih bolesnika visokim s mješovitim dislipidemijom za smanjenje triglicerida i povećanje razine hdl c kad ldl c razinama adekvatno upravlja pomoću odgovarajuće doze monoterapije simvastatinom.

Europska Unija - hrvatski - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - ziconotide - injections, spinal; pain - analgetici - zikonotid je indiciran za liječenje teške, kronične boli u bolesnika koji zahtijevaju intratekalnu (it) analgeziju.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - fampridine - multipla skleroza - ostali lijekovi protiv živčanog sustava - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7).

Europska Unija - hrvatski - EMA (European Medicines Agency)

forte healthcare limited - fluoksetin - psychoanaleptics - psi - kao pomoćno sredstvo u liječenju podjela ovisi o bolesti kod pasa se očituje uništavanja i neadekvatnih oblika ponašanja (govor i neprimjereno stolicu i / ili mokrenje), a tek u kombinaciji s bihevioralne modifikacije metode.

Europska Unija - hrvatski - EMA (European Medicines Agency)

1 a pharma gmbh - rivastigmin - alzheimer disease; dementia; parkinson disease - psychoanaleptics, - simptomatsko liječenje blage do umjereno teške alzheimerove demencije. simptomatsko liječenje blage do umjereno teške demencije kod pacijenata sa idiopatskom parkinsonovom bolešću.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ratiopharm gmbh - memantin hidroklorid - alzheimerova bolest - psychoanaleptics, - liječenje bolesnika s umjerenom ili teškom alzheimerovom bolesti.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz gmbh - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bayer animal health gmbh - флорфеникол, terbinafine hidroklorid, mometasone фуроат - otologicals, kortikosteroidi i противоинфекционные u kombinaciji - psi - za liječenje akutnih pas отита ili akutni i pogoršanja рецидивирующих отитов uzrokovane miješanim infekcijama, osjetljivim sojevima bakterija, osjetljivi na флорфениколу (pseudintermedius aureus) i gljivice je osjetljiva na тербинафину (kvasac je vrsta malassezia pachydermatis).

Europska Unija - hrvatski - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.