Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - arzenov trioksid - levkemija, promyelocytic, akutna - antineoplastična sredstva - arzenov trioksid, ki je primerna za indukcijo remisije, in konsolidacije pri odraslih bolnikih z:novo diagnosticiranih nizko-za-srednje tveganje akutna promyelocytic levkemijo (apl) (belih krvnih telesc, ≤ 10 x 103/µl) v kombinaciji z all-trans-retinojske kisline (atra)relapsed/ognjevzdržni akutna promyelocytic levkemijo (apl)(prejšnje zdravljenje mora imeti vključen retinoid in kemoterapijo) značilna prisotnost t(15;17) translokacija in/ali prisotnosti promyelocytic levkemijo/retinojske kisline-receptor-alfa (pml/rar-alfa) gena. odgovor stopnja drugih akutnih myelogenous levkemijo podtipov, da arzenov trioksid, ki še niso bili pregledani.

Evropska unija - slovenščina - EMA (European Medicines Agency)

theratechnologies europe limited - ibalizumab - okužbe z virusom hiv - antivirusi za sistemsko uporabo - trogarzo, v kombinaciji z drugimi protiretrovirusnimi(s), je indiciran za zdravljenje odraslih, okuženih z multidrug odporne hiv-1 okužbe, za katero je drugače ni mogoče zgraditi supresivno protivirusno režim.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited  - siponimod fumaric acid - multiplo sklerozo, recidivno-nakazila - selektivni imunosupresivi - mayzent je indiciran za zdravljenje odraslih bolnikov s sekundarno progresivno multiplo sklerozo (spms), ki imajo aktivno bolezen, dokazuje zagonov ali slikovne funkcije vnetne aktivnosti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ireland limited - arzenov trioksid - levkemija, promyelocytic, akutna - antineoplastična sredstva - arzenov trioksid mylan je primerna za indukcijo remisije, in konsolidacije pri odraslih bolnikih z:- na novo diagnosticirana nizko ali srednje tveganje akutna promyelocytic levkemijo (apl) (belih krvnih telesc, ≤ 10 x 103/µl) v kombinaciji z vsemi trans retinojske kisline (atra)- relapsed/ognjevzdržni akutna promyelocytic levkemijo (apl) (prejšnje zdravljenje mora imeti vključen retinoid in kemoterapijo)značilna prisotnost t(15;17) translokacija in/ali prisotnosti promyelocytic levkemijo/retinojske kisline receptorjev alfa (pml/rar alfa) gena. odgovor stopnja drugih akutnih myelogenous levkemijo podtipov, da arzenov trioksid ni beenexamined.

Evropska unija - slovenščina - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arzenov trioksid - levkemija, promyelocytic, akutna - antineoplastična sredstva - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene. odgovor stopnja drugih akutnih myelogenous levkemijo podtipov, da arzenov trioksid, ki še niso bili pregledani.

Evropska unija - slovenščina - EMA (European Medicines Agency)

stemline therapeutics b.v. - tagraxofusp - lymphoma - antineoplastična sredstva - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

Evropska unija - slovenščina - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - okužbe z virusom hiv - antivirusi za sistemsko uporabo - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Evropska unija - slovenščina - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - tiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastična sredstva - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Evropska unija - slovenščina - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - psi - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.