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)

biopartners gmbh - somatropin - turner syndrome; dwarfism, pituitary - hipofize in hipotalamični hormoni in analogi - pediatrični poulationlong-izraz zdravljenje otrok (od 2 do 11 let) in mladostnikih (od 12 do 18 let), z rastjo okvare zaradi neustreznega izločanja normalno endogeno rastni hormon. zdravljenje nižje rasti pri otrocih z sindrom turner, potrjeno z analizo kromosomske. zdravljenje rasti v maternici v pre-pubertete otrok s kronično ledvično insuficienco. odraslih patientsreplacement terapija pri odraslih z izrazito rastni hormon pomanjkljivosti bodisi otroštva, ali za odrasle-nastop aetiology. bolniki s hudo pomanjkanje rastnega hormona v odraslost so opredeljene kot bolnikih z znano hypothalamic-hipofiza patologija in vsaj eno dodatno znane pomanjkljivosti, a hormon hipofize, ne bi prolaktina. ti bolniki morajo opraviti eno dinamični test za diagnosticiranje ali izključi pomanjkanje rastnega hormona. pri bolnikih s otroštva-nastop izoliranih rastni hormon pomanjkljivosti (ni dokazov o hypothalamic-hipofiza bolezni ali lobanjski obsevanje), dveh dinamičnih preskusov je treba priporočljivo, razen za tiste, ki imajo nizko inzulinu podoben rastni faktor-1 (igf-1) koncentracije (< 2 standardni odklon točk (sds)),, ki se lahko šteje za en test. cut-off point dinamični preskus je treba strogo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - fampridine - multiple skleroza - druga zdravila na živčnem sistemu - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7).

Evropska unija - slovenščina - EMA (European Medicines Agency)

bayer animal health gmbh - florfenicol, terbinafine hidroklorid, mometasone furoate - otologicals, kortikosteroidi in antiinfectives v kombinaciji - psi - za zdravljenje akutnih udarci otitis externa ali akutno exacerbations ponavljajočih se otitis, ki jih povzročajo mešane okužbe dovzetni sevov bakterije občutljive za florfenicol (staphylococcus pseudintermedius) in gliv, občutljiv na terbinafine (malassezia pachydermatis).

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

fresenius kabi deutschland gmbh - meropenem - prašek za raztopino za injiciranje/infundiranje - meropenem 1 g / 1 steklenica - meropenem

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

fresenius kabi deutschland gmbh - meropenem - prašek za raztopino za injiciranje/infundiranje - meropenem 1 g / 1 steklenica - meropenem

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

fresenius kabi deutschland gmbh - meropenem - prašek za raztopino za injiciranje/infundiranje - meropenem 500 mg / 1 steklenica - meropenem

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

fresenius kabi deutschland gmbh - meropenem - prašek za raztopino za injiciranje/infundiranje - meropenem 500 mg / 1 steklenica - meropenem