Eesti - eesti - Ravimiamet

aventis pharma international sa - busereliin - ninasprei, lahus - 0,15mg 1annus 10ml 2tk

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatiniib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatiniib - 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. välja arvatud äsja diagnoositud kroonilise faasi cml, ei ole kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused. .

Euroopa Liit - eesti - EMA (European Medicines Agency)

teva b.v. - imatiniib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva on näidustatud ravi ofadult ja pediaatrilised patsiendid, kellel on äsja diagnoositud philadelphia kromosoomi (bcr‑abl) positiivse (ph+) krooniline müeloidne leukeemia (cml) ja kelle jaoks luuüdi siirdamine ei loeta esimese rea ravi. täiskasvanud ja pediaatriliste patsientide puhul, mille ph+ cml krooniline faas pärast rikke interferoon‑alfa ravi, või kiirendatud faasi või lööklaine kriis. täiskasvanute ja laste patsientidel, kellel on äsja diagnoositud philadelphia kromosoom positiivne ägeda lümfoblastilise leukeemia (ph+ all) integreeritud keemiaravi. täiskasvanud patsientidel, kellel on taastekkinud või tulekindlad ph+ kÕik nagu monotherapy. täiskasvanud patsientidel, kellel müelodüsplastiline/myeloproliferative haiguste (mds/mpd), mis on seotud trombotsüütide saadud kasvufaktori retseptori (pdgfr) geen uuesti kord. täiskasvanud patsientidel, kellel on arenenud hypereosinophilic sündroomi (hes) ja/või kroonilise eosinophilic leukeemia (cel) koos fip1l1-pdgfra ümberasetusega. mõju imatinib tulemuste kohta luuüdi siirdamine ei ole kindlaks. 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. patsientidel, kellel on madal või väga madal risk kordumise ei tohiks saada abiaine ravi. 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. välja arvatud äsja diagnoositud kroonilise faasi cml, ei ole kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused.

Euroopa Liit - eesti - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastilised ained - 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. patsientidel, kellel on madal või väga madal risk kordumise ei tohiks saada abiaine ravi. 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. välja arvatud äsja diagnoositud kroonilise faasi cml, ei ole kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused.

Euroopa Liit - eesti - EMA (European Medicines Agency)

actavis group ptc ehf - imatiniib - 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. mõju imatinib tulemuste kohta luuüdi siirdamine ei ole kindlaks. 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. kogemus imatinib patsientidel mds/mpd seotud pdgfr geeni taas-kord on väga piiratud. puuduvad kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radionukliidi pildistamine - diagnostilised radiofarmatseutilised ühendid - see ravim on mõeldud ainult diagnostiliseks kasutamiseks. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - imatiniib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastilised ained - glivec 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-pdgfra rearrangement. mõju glivec tulemuste kohta luu-üdi siirdamine ei ole kindlaks. glivec is indicated for: , 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. patsientidel, kellel on madal või väga madal risk kordumise ei tohiks saada abiaine ravi; ravi täiskasvanud patsientidel, kellel unresectable dermatofibrosarcoma protuberans (dfsp) ja täiskasvanud patsientidel korduva ja / või metastaatilise dfsp, kes ei ole abikõlblikud operatsioon. , täiskasvanud ja pediaatriliste patsientide, tõhususe glivec põhineb üldine hematoloogiline ja tsütogeneetiline ravivastus, ja progression-free survival in cml, hematoloogiline ja tsütogeneetiline ravivastus, ph+ all, mds / mpd, hematoloogiline ravivastus, in hes / cel ja objektiivne ravivastus, täiskasvanud patsientidel unresectable ja / või metastaatilise pÕhisisu ja dfsp ja kordumise-free survival in abiaine pÕhilised. kogemus glivec patsientidel mds / mpd seotud pdgfr geeni taas-kord on väga piiratud (vt lõik 5. välja arvatud äsja diagnoositud kroonilise faasi cml, ei ole kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused.

Euroopa Liit - eesti - EMA (European Medicines Agency)

medac - imatiniib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - protein kinase inhibiitorid - imatinib medac on näidustatud ravi:pediaatrilised patsiendid, kellel on äsja diagnoositud philadelphia kromosoomi (bcr-abl) positiivse (ph+) krooniline müeloidne leukeemia (cml) ja kelle jaoks luuüdi siirdamine ei loeta esimese rea ravi;pediaatriliste patsientide puhul, mille ph+cml krooniline faas pärast rikke interferoon-alfa ravi, või kiirendatud etapp;täiskasvanud ja pediaatriliste patsientide puhul, mille ph+cml lööklaine kriis;täiskasvanute ja laste patsientidel, kellel on äsja diagnoositud philadelphia kromosoom positiivne ägeda lümfoblastilise leukeemia (ph+all) integreeritud keemiaravi;täiskasvanud patsientidel, kellel on taastekkinud või tulekindlad ph+kÕik nagu monotherapy;täiskasvanud patsientidel müelodüsplastiline/myeloproliferative haiguste (mds/mpd), mis on seotud trombotsüütide saadud kasvufaktori retseptori (pdgfr) geen uuesti korra;täiskasvanud patsientidel, kellel on arenenud hypereosinophilic sündroomi (hes) ja/või kroonilise eosinophilic leukeemia (cel) fip1l1-pdgfra ümberasetusega;täiskasvanud patsientidel unresectable dermatofibrosarcoma protuberans (dfsp) ja täiskasvanud patsientidel korduva ja/või metastaatilise dfsp, kes ei ole abikõlblikud operatsioon. mõju imatinib tulemuste kohta luuüdi siirdamine ei ole kindlaks. täiskasvanud ja pediaatriliste patsientide, tõhususe imatinib põhineb üldine hematoloogiline ja tsütogeneetiline ravivastus, ja progression-free survival in cml, hematoloogiline ja tsütogeneetiline ravivastus, ph+all, mds/mpd, hematoloogiline ravivastus, in hes/cel ja objektiivne ravivastus, täiskasvanud patsientidel unresectable ja/või metastaatilise dfsp. kogemus imatinib patsientidel mds/mpd seotud pdgfr geeni taas-kord on väga piiratud. välja arvatud äsja diagnoositud kroonilise faasi cml, ei ole kontrollitud uuringud, mis näitab kliiniline kasu või suurenenud ellujäämise eest need haigused.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dasatiniib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastilised ained - sprycel on näidustatud ravi pediaatrilised patsiendid:äsja diagnoositud philadelphia-kromosoom-positiivse kroonilise müeloidse leukeemia kroonilise faasi (ph+ cml cp) või ph+ cml cp resistentsed või talumatus eelneva ravi (sh imatinib. äsja diagnoositud ph+ ägeda lümfoblastilise leukeemia (all) kombinatsioonis keemiaraviga. sprycel on näidustatud ravi täiskasvanud patsientidel, kellel on:äsja diagnoositud philadelphia-kromosoom-positiivse (ph+) kroonilise müeloidse leukeemia (cml) kroonilise faasi;krooniline, kiirendatud või lööklaine faasis cml, mille resistentsus või talumatus eelneva ravi (sh imatinib mesilate;ph+ ägeda lümfoblastilise leukeemia (all) ja lümfisüsteemi lööklaine cml, mille resistentsus või talumatus eelneva ravi. sprycel on näidustatud ravi pediaatrilised patsiendid:äsja diagnoositud ph+ cml krooniline faas (ph+ cml-cp) või ph+ cml-cp resistentsed või talumatus eelneva ravi (sh imatinib.

Euroopa Liit - eesti - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - muud antineoplastilised ained - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.