Union européenne - slovène - 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.

Union européenne - slovène - EMA (European Medicines Agency)

pfizer europe ma eeig - somatrogon - growth and development - hipofiza in hypothalamic hormoni in analogi - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.

Union européenne - slovène - EMA (European Medicines Agency)

ascendis pharma endocrinology division a/s - lonapegsomatropin - growth and development - hipofize in hipotalamični hormoni in analogi - growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [ghd]),.

Union européenne - slovène - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastična sredstva - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

fresenius kabi deutschland gmbh - linezolid - raztopina za infundiranje - linezolid 2 mg / 1 ml - linezolid

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

fresenius kabi deutschland gmbh - linezolid - raztopina za infundiranje - linezolid 2 mg / 1 ml - linezolid

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

intervet international -

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

boehringer ingelheim vetmedica gmbh 55216 ingelheim/rhein nemČija 2 -

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka, d.d., novo mesto - amoksicilin, klavulanska kislina - prašek za peroralno suspenzijo - amoksicilin 400 mg / 5 ml; klavulanska kislina 57 mg / 5 ml - amoksicilin in zaviralec laktamaz beta

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka -