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.

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

imatinib - filmsko obložena tableta - imatinib 400 mg / 1 tableta - imatinib

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

imatinib - filmsko obložena tableta - imatinib 100 mg / 1 tableta - imatinib

Evropska unija - slovenščina - EMA (European Medicines Agency)

lupin europe gmbh - mexiletine hydrochloride - myotonic motnje - srčna terapija - namuscla je primerna za simptomatsko zdravljenje myotonia pri odraslih bolnikih z ne-dystrophic myotonic motnje.

Evropska unija - slovenščina - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituksimab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastična sredstva - rituzena je navedeno v odraslih za naslednje indikacije:ne-hodgkinova limfomi (nhl)rituzena je primerna za zdravljenje predhodno nezdravljenih bolnikov s fazo iii iv folikularni limfom v kombinaciji s kemoterapijo. rituzena monotherapy je indiciran za zdravljenje bolnikov z faza iii iv folikularni limfom, ki so kemo odporne ali so v drugi ali poznejši ponovitve po kemoterapijo. rituzena je indiciran za zdravljenje bolnikov z cd20 pozitivni razpršenih velika b celic, ki niso hodgkinova limfom v kombinaciji z chop (ciklofosfamid, doxorubicin, vincristine, prednizolon) kemoterapijo. kronično limfocitno levkemijo (cll)rituzena v kombinaciji s kemoterapijo je indiciran za zdravljenje bolnikov z predhodno nezdravljenih in relapsed/ognjevzdržni cll. samo omejeni so na voljo podatki o učinkovitosti in varnosti za bolnike predhodno zdravljenih z monoklonalna protitelesa, vključno z rituzenaor bolnikov, ognjevzdržni, da prejšnji rituzena plus kemoterapijo. granulomatosis z polyangiitis in mikroskopsko polyangiitisrituzena, v kombinaciji z glucocorticoids, je primerna za indukcijo remisije pri odraslih bolnikih s hudo, aktivno granulomatosis z polyangiitis (wegener) (gpa) in mikroskopsko polyangiitis (mpa).

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

novartis pharma gmbh - letrozol - filmsko obložena tableta - letrozol 2,5 mg / 1 tableta - letrozol

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

mylan healthcare d.o.o. - trandolapril; verapamil - tableta s podaljšanim sproščanjem - trandolapril 2 mg / 1 tableta  verapamil222,19 mg / 1 tableta; verapamil 222,19 mg / 1 tableta - trandolapril in verapamil

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

teva gmbh - glatiramer - raztopina za injiciranje v napolnjeni injekcijski brizgi - glatiramer 18 mg / 1 ml - glatiramerijev acetat

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

teva gmbh - glatiramer - raztopina za injiciranje - glatiramer 36 mg / 1 ml - glatiramerijev acetat

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

novartis pharma gmbh - oktreotid - prašek in vehikel za suspenzijo za injiciranje - oktreotid 10 mg / 1 viala - oktreotid