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)

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)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib-tewa indiciran za liječenje ofadult i pedijatrijska bolesnika s je prvi put dijagnosticiran Филадельфийской hromozoma (na bcr‑abl), koji je pozitivan (ph+) kronične mijeloične leukemije (kml), za koje je transplantacija koštane srži ne smatra se kao prva linija liječenja. za odrasle i pedijatrijska bolesnika s ph+ kml u fazi kroničnog neučinkovitosti interferon‑alfa terapija, ili u ubrzanu fazu ili бластного kriza. i pedijatrijski bolesne odrasle osobe s prvi put utvrđenom pozitivnom akutne limfoblastične leukemije Филадельфийская kromosom (ph+ all) u kombinaciji s kemoterapijom. za odrasle pacijenata s relaps ili vatrostalne ph+ all u monoterapiji. odraslih pacijenata s миелодиспластический/миелопролиферативными bolesti (mds/rafinerija), povezanim sa бляшк-выведенное ako uređaj primatelja faktor rasta (pdgfr) promjena u kromosomu preustroj. kod odraslih pacijenata sa sindromom napredno гиперэозинофильный (hes) i/ili kronične eozinofilni leukemije (osobe) sa fip1l1-pdgfra preokret. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib teva 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)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - inhibitori протеинкиназы - Иматиниба medak je propisan za liječenje:pedijatrijska bolesnika s je prvi put dijagnosticiran Филадельфийской hromozoma (bcr-abl), koji je pozitivan (ph+) kronične mijeloične leukemije (kml), za koje je transplantacija koštane srži ne smatra se kao prva linija liječenja;pedijatrijska bolesnika s ph+kml u fazi kroničnog neučinkovitosti interferon-alfa terapija, ili u ubrzanu fazu;obrazovanje odraslih i pedijatrijska bolesnika s ph+kml u бластный kriza;obrazovanje za odrasle i pedijatrijska bolesnika s prvi put utvrđenom pozitivnom akutne limfoblastične leukemije Филадельфийская kromosom (ph+all) integrirani s kemoterapijom;za odrasle pacijenata s relaps ili vatrostalne ph+all u monoterapiji;kod odraslih pacijenata s миелодиспластических/миелопролиферативных bolesti (mds/rafinerija), povezanim sa бляшк-выведенное ako uređaj primatelja faktor rasta (pdgfr) gen permutacije;za odrasle pacijente s прогрессирующим гиперэозинофильным sindrom (hps) i/ili kronične eozinofilni leukemije (osobe) sa fip1l1-pdgfra se okupile;za odrasle pacijente s метастатической выбухающей dermatofibrosarcoma (dfsp) i odraslih pacijenata s relaps i/ili метастатической dfsp, koji nemaju pravo na operaciju. učinak иматиниба na ishod transplantacije koštane srži nije određena. u odrasle osobe i pedijatrijska bolesnika, učinkovitost иматиниба se temelji na zajedničkim гематологических i цитогенетических odgovora i preživljavanja bez progresije kod kml, na гематологический i цитогенетический odgovor cijene na ph+all, mds/rafinerija, na гематологические indikatori odgovora u hes/cel i objektivnih odgovora kod odraslih pacijenata s operirati i/ili метастатической dfsp. iskustvo s иматинибом u bolesnika s mds/rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

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

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - imatinibum - filmom obložena tableta - 100 mg - urbroj: svaka filmom obložena tableta sadrži 119,5 mg imatinibmesilata što odgovara 100 mg imatiniba

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

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - imatinibum - filmom obložena tableta - 200 mg - urbroj: svaka filmom obložena tableta sadrži 239 mg imatinibmesilata što odgovara 200 mg imatiniba

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

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - imatinibum - filmom obložena tableta - 300 mg - urbroj: svaka filmom obložena tableta sadrži 358,5 mg imatinibmesilata što odgovara 300 mg imatiniba

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

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - imatinibum - filmom obložena tableta - 400 mg - urbroj: svaka filmom obložena tableta sadrži 478 mg imatinibmesilata što odgovara 400 mg imatiniba

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

cipla europe nv, uitbreidingstraat 80, antwerpen, belgija - imatinibum - kapsula, tvrda - 100 mg - urbroj: jedna tvrda kapsula sadrži 100 mg imatiniba (u obliku mesilata)