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)

dendreon uk ltd - avtologni mononuklearnih celic periferne krvi, vključno z najmanj 50 milijonov avtologna cd54 + celice activated s prostate kisline fosfataze makrofagov granulocitne kolonije stimulirajoči faktor - prostatične neoplazme - drugi imunostimulanti - za zdravljenje asimptomatskega ali minimalno simptomatskega metastatskega (nestardalnega) kastratnega odpornega raka na prostati pri odraslih moških, pri katerem kemoterapija še ni klinično indicirana.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - bevacizumab - colorectal neoplasms; breast neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - zirabev v kombinaciji z fluoropyrimidine temeljijo na kemoterapijo je indiciran za zdravljenje odraslih bolnikov z metastatskim karcinom debelega črevesa in danke. zirabev v kombinaciji z paclitaxel je določen za prvo linijo za zdravljenje odraslih bolnikov z metastatskim rakom dojke,. za dodatne informacije, kot na človeško epidermalna rast factor receptor 2 (her2) stanje. zirabev, poleg platinum, ki temelji kemoterapijo, je označen za prvo linijo zdravljenja odraslih bolnikih z unresectable napredno, metastatskega ali ponavljajoče se non-small cell lung cancer razen pretežno skvamoznih celic histologija. zirabev v kombinaciji z interferonom alfa-2a, ki je navedena za prvi vrstici zdravljenje odraslih bolnikov z napredno in/ali metastatskim karcinomom raka. zirabev, v kombinaciji z paclitaxel in cisplatin, ali, alternativno, paclitaxel in topotecan pri bolnikih, ki ne morejo prejemati platinum terapija je primerna za zdravljenje odraslih bolnikov z vztrajno, periodično, ali metastatskim karcinom materničnega vratu.

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)

allergan pharmaceuticals ireland - prašek za raztopino za injiciranje - botulinski toksin

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

ceva sante animale -

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

ceva -

Evropska unija - slovenščina - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multiple myeloma - antineoplastična sredstva - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

intervet international b.v. - v živo myxoma vectored rhd virus sev 009, Živo myxoma vectored rhd virus sev mk1899 - immunologicals za leporidae - kunci - za aktivno imunizacijo kuncev od 5. tedna starosti dalje za zmanjšanje umrljivosti in kliničnih znakov miksomatoze in zajec hemoragične bolezni (rhd), ki jih povzročajo klasični rhd virus (rhdv1) in rhd tipa 2 virus (rhdv2).

Evropska unija - slovenščina - EMA (European Medicines Agency)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - drugi zdravljene bolezni prebavil in presnove izdelki, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.