Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

servier pharma d.o.o. - ivabradin, metoprololijev tartrat - filmsko obložena tableta - ivabradin 7,5 mg / 1 tableta; metoprololijev tartrat 50 mg / 1 tableta - metoprolol in ivabradin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

servier pharma d.o.o. - ivabradin; metoprololijev tartrat - filmsko obložena tableta - ivabradin 5 mg / 1 tableta  metoprololijev tartrat50 mg / 1 tableta; metoprololijev tartrat 50 mg / 1 tableta - metoprolol in ivabradin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

sanolabor, d.d. - metoprololijev tartrat - raztopina za injiciranje - metoprololijev tartrat 1 mg / 1 ml - metoprolol

Evropska unija - slovenščina - 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. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni. .

Evropska unija - slovenščina - EMA (European Medicines Agency)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - proteinska kinaza inhibitorji - imatinib medac je primerna za zdravljenje:pediatrični bolniki z na novo prijavljenih philadelphia kromosom (bcr-abl) pozitivna (ph+) kronično mieloično levkemijo (cml), za katere presaditev kostnega mozga, se ne šteje kot prva linija zdravljenja;pediatričnih bolnikih s ph+cml v kronični fazi po izpadu interferon-alfa terapije, ali v pospešeni fazi;izobraževanja odraslih in pediatričnih bolnikih s ph+cml v blastni krizi;izobraževanja odraslih in pediatričnih bolnikih, ki so na novo zboleli za philadelphia kromosom pozitivno acute lymphoblastic levkemijo (ph+all) integriran s kemoterapijo;odraslih bolnikih z relapsed ali ognjevzdržni ph+all, kot monotherapy;odraslih bolnikih z myelodysplastic/myeloproliferative bolezni (mds/mpd), ki je povezana z trombocitov, pridobljenih iz rastni dejavnik receptorjev (pdgfr) gena ponovno ureditve;za odrasle bolnike z napredovalim hypereosinophilic sindromom (hes) in/ali kronično eozinofilno levkemijo (cel) z fip1l1-pdgfra preureditev;odraslih bolnikih z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in/ali metastatskim dfsp, ki niso primerni za operacijo. učinek imatinib na izid presaditev kostnega mozga, ni bilo določeno. pri odraslih in pediatričnih bolnikih, učinkovitost imatinib temelji na splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+all, mds/mpd, na hematoloških stopnjo odziva, v hes/cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in/ali metastatskim dfsp. izkušnje z imatinib pri bolnikih z mds/mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejena. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - imatinib teva b. 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. , pediatričnih bolnikih s ph+ cml v kronični fazi po izpadu interferon-alfa terapije, ali v pospešeni fazi ali pišu krize. odrasli bolniki s ph+ cml v blastni krizi. , odraslih in pediatričnih bolnikih, ki so na novo zboleli za philadelphia kromosom pozitivno acute lymphoblastic levkemijo (ph+ all), ki je integriran z kemoterapijo. odrasli bolniki z relapsed ali ognjevzdržni ph+ all, kot monotherapy. odrasli bolniki z myelodysplastic/myeloproliferative bolezni (mds/mpd), ki je povezana z trombocitov, pridobljenih iz rastni dejavnik receptorjev (pdgfr) gena ponovno ureditev. odrasli bolniki z napredno hypereosinophilic sindromom (hes) in/ali kronično eozinofilno levkemijo (cel) z fip1l1-pdgfra preureditev. učinek imatinib na izid presaditev kostnega mozga, ni bilo določeno. imatinib teva b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). , adjuvant zdravljenje odraslih bolnikov, ki so na veliko nevarnost ponovitve naslednje resekcija kit (cd117)-pozitivno bistvo. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. , zdravljenje odraslih bolnikov z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in/ali metastatskim dfsp, ki niso primerni za operacijo. v izobraževanju odraslih in pediatričnih bolnikov, učinkovitost imatinib temelji na splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+ all, mds/mpd, na hematoloških stopnjo odziva, v hes/cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in/ali metastatskim bistvo in dfsp in na ponovitev-free survival v adjuvant bistvo. izkušnje z imatinib pri bolnikih z mds/mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejena. ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Evropska unija - slovenščina - 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 - 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. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. 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. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - gefitinib - karcinom, pljučni pljuč - antineoplastična sredstva - iressa je indiciran za zdravljenje odraslih bolnikov z lokalno napredno ali metastatskim non-small-cell lung cancer z aktiviranjem mutacije od epidermalna-rast-faktor-receptor tirozin kinaza.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi winthrop industrie - dronedaron - atrijska fibrilacija - srčna terapija - zdravilo multaq je indicirano za vzdrževanje sinusnega ritma po uspešni kardioverziji pri odraslih klinično stabilnih bolnikih s paroksizmalno ali persistentno atrijsko fibrilacijo (af). zaradi svojega varnostnega profila je treba zdravilo multaq predpisati le po preučitvi alternativnih možnosti zdravljenja. multaq ne smemo dajati bolnikom z levega prekata sistolični disfunkcija ali za bolnike s sedanjih ali prejšnjih epizod srčnega popuščanja.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

novartis pharma gmbh - terbinafin - tableta - terbinafin 250 mg / 1 tableta - terbinafin