האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - attenuated feline rhinotracheitis herpesvirus (fhv f2 strain), inactivated feline calicivirosis antigens (fcv 431 and g1 strains), attenuated feline panleucopenia virus (pli iv), felv recombinant canarypox virus (vcp97), attenuated chlamydophila felis (905 strain) - immunologicals za skupin felidae, - mačke - active immunisation of cats aged 8 weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs;against chlamydophila felis infection to reduce clinical signs;against feline panleucopenia to prevent mortality and clinical signs;against leukaemia to prevent persistent viraemia and clinical signs of the related disease. onsets of immunity are 1 week after primary vaccination course for rhinotracheitis, calicivirus, chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component. the duration of immunity is one year after the last re-vaccination for the chlamydiosis and feline leukaemia components, and one year after primary vaccination course and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

seqirus gmbh - virus influence površinskih antigenov (haemagglutinin in neuraminidase), inaktivirano, naslednjih vrst:a/california/7/2009 (h1n1)pdm09 - kot sev(a/brisbane/10/2010, divji tip)a/Švica/9715293/2013 (h3n2) - kot sev(a/južna avstralija/55/2014, divji tip)b/phuket/3073/2013–kot sev(b/utah/9/2014, divji tip) - influenza, human; immunization - cepiva - preprečevanje influence za odrasle, zlasti pa pri tistih, ki vodijo povečano tveganje za zaplete, povezane. optaflu je treba uporabljati v skladu z uradnimi smernice.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastična sredstva - glivec 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-pdgfra rearrangement. učinek glivec na izid kostnega mozga presaditev ni bilo določeno. glivec is indicated for: , 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. 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 glivec je na podlagi 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 glivec pri bolnikih z mds / mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejeno (glej poglavje 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

סלובניה - סלובנית - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

bayer -

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

novartis europharm limited  - onasemnogene abeparvovec - mišična atrofija, hrbtenica - druga zdravila za motnje mišično-skeletnega sistema - zolgensma je primerna za zdravljenje:pri bolnikih z 5q hrbtenice mišična atrofija (sma) z dvo-allelic mutacije v smn1 gena in klinično diagnozo sma tipa 1, orpatients z 5q sma z dvo-allelic mutacije v smn1 gena in do 3 kopije gena smn2.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - druga zdravila na živčnem sistemu - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateron acetat - prostatične neoplazme - endokrini terapija - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

האיחוד האירופי - סלובנית - 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.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

mylan ireland limited - abirateron acetat - prostatične neoplazme - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

krka, d.d., novo mesto - abirateron acetat - prostatične neoplazme - endokrini terapija - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.