Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - lakozamida - epilepsija - antiepileptici sredstva, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateron acetat - prostatske neoplazme - endokrinska terapija - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

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)

accord healthcare s.l.u. - bortezomib - multipli mijelom - antineoplastična sredstva - akord бортезомиб kao monoterapija ili u kombinaciji s пегилированным липосомальным doksorubicin i дексаметазоном indiciran za liječenje odraslih bolesnika s napreduje multiplog mijeloma, koji je dobio najmanje 1 prije početka terapije i koji su već prošli ili koji nisu prikladni za hematopoetski sustav transplantacije matičnih stanica . Бортезомиб akord u kombinaciji s мелфаланом i преднизолоном indiciran za liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma koji se ne mogu tvrditi da su visoke doze kemoterapije s transplantacije matičnih stanica hematopoetske . akord бортезомиб u kombinaciji s дексаметазоном, ili s deksametazona i талидомида je za indukcije liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma, koji imaju pravo na высокодозная kemoterapija s transplantacije matičnih stanica hematopoetske . Бортезомиб akord u kombinaciji s rituksimab, ciklofosfamid, doksorubicin i prednizolona indiciran za liječenje odraslih bolesnika s ranije neobrađeni limfoma iz stanica plašt, koji nisu spremni za transplantaciju гемопоэтических matičnih stanica .

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

accord healthcare polska sp. z o.o., ul. tasmowa 7, mazowieckie, varšava, poljska - fludarabinfosfat - koncentrat za otopinu za injekciju/infuziju - 25 mg/ml - urbroj: svaki ml sadrži 25 mg fludarabinfosfata

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

accord healthcare polska sp. z o.o., ul. lutomierska 50, pabianice, poljska - ciklofosfamid hidrat - prašak za otopinu za injekciju / infuziju - urbroj: 1 bočica 2000 mg ciklofosfamida u obliku ciklofosfamid hidrata, 1 ml rekonstituirane otopine sadrži 20 mg ciklofosfamida.

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

accord healthcare polska sp. z o.o., ul. tasmowa 7, mazowieckie, varšava, poljska - ritonavir - filmom obložena tableta - 100 mg - urbroj: jedna filmom obložena tableta sadrži 100 mg ritonavira

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

accord healthcare polska sp. z o.o., ul. tasmowa 7, mazowieckie, varšava, poljska - темсиролимус - koncentrat i otapalo za otopinu za infuziju - 30 mg - urbroj: jedna bočica koncentrata za otopinu za infuziju sadrži 30 mg temsirolimusa

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

accord healthcare polska sp. z o.o., ul. tasmowa 7, mazowieckie, varšava, poljska - mikofenolatnatrij - želučanootporna tableta - 360 mg - urbroj: jedna želučanootporna tableta sadrži 360 mg mikofenolatne kiseline u obliku mikofenolatnatrija

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

accord healthcare polska sp. z o.o., ul. tasmowa 7, mazowieckie, varšava, poljska - irinotekanklorid trihidrat - koncentrat za otopinu za infuziju - 20 mg/ml - urbroj: 1 ml koncentrata sadrži 20 mg irinotekanklorid trihidrata, što odgovara 17,33 mg irinotekana