Credelio Unia Europejska - słoweński - EMA (European Medicines Agency)

credelio

elanco gmbh - lotilaner - ectoparasiticides za sistemsko uporabo, isoxazolines - dogs; cats - za zdravljenje bolh in klopi infestations. bolhe in klopi mora priložiti gostiteljice in začne hranjenje, da bi izpostavljene aktivni snovi,. zdravilo za uporabo v veterinarski medicini se lahko uporablja kot del strategije zdravljenja za nadzor alergijskega dermatitisa bolha (fad). dogsthis zdravila zagotavlja takojšnje in dolgotrajne ubijanje dejavnosti za 1 mesec za bolhe (ctenocephalides felis in c. canis) in klopi (rhipicephalus sanguineus, ixodes ricinus, i. hexagonus in dermacentor reticulatus). catsthis zdravila zagotavlja takojšnje in dolgotrajne ubijanje dejavnosti za 1 mesec pred bolhe (ctenocephalides felis in c. canis) in klopi (ixodes ricinus).

Masican Unia Europejska - słoweński - EMA (European Medicines Agency)

masican

masitinib - gastrointestinalni stromalni tumorji - proteinska kinaza inhibitorji - zdravljenje unresectable in/ali metastatskim maligni gastrointestinal stromal tumorjev (bistvo).

Cervarix Unia Europejska - słoweński - EMA (European Medicines Agency)

cervarix

glaxosmithkline biologicals s.a. - človekove papillomavirus1 tip 16 l1 beljakovin, human papillomavirus 18. vrsta beljakovine l1 - papillomavirus infections; uterine cervical dysplasia; immunization - cepiva - cervarix je cepivo za uporabo v starosti od 9 let za preprečevanje predrakave ano-genitalne poškodbe (materničnega vratu, vulve, vaginalni in analni) in raka materničnega vratu in analni vzročno povezane z določeno oncogenic humani papiloma virus (hpv). glej poglavja 4. 4 in 5. 1 za pomembne podatke o podatkih, ki podpirajo to indikacijo. uporaba cervarix je treba v skladu z uradnimi priporočili.

Imatinib Accord Unia Europejska - słoweński - EMA (European Medicines Agency)

imatinib accord

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. .