Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - levkemija, limfocitna, kronična, b-celica - monoklonska protitelesa - predhodno nezdravljenih kronično limfocitno levkemijo (cll): arzerra v kombinaciji z chlorambucil ali bendamustine je indiciran za zdravljenje bolnikov z cll, ki še niso prejeli pred terapijo in ki niso upravičeni do fludarabine, ki temelji terapija. relapsed cll: arzerra je navedeno v kombinaciji z fludarabine in ciklofosfamid za zdravljenje odraslih bolnikov z relapsed cll. ognjevzdržni cll: arzerra je primerna za zdravljenje cll pri bolnikih, ki so utrjene, da fludarabine in alemtuzumab.

Evropska unija - slovenščina - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurija, paroksizmal - selektivni imunosupresivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Evropska unija - slovenščina - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinurija, paroksizmal - imunosupresivi - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.

Evropska unija - slovenščina - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - imunosupresivi - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis serogroup b fhbp (rekombinantni lipidirani fhbp (faktor h vezavni protein)) poddružina a; neisseria meningitidis serogroup b fhbp (rekombinantni lipidirani fhbp (faktor h vezavnega proteina)) podfamil b - meningitis, meningokokni - bacterial vaccines, meningococcal vaccines - trumenba je indicirana za aktivno imunizacijo posameznikov, starih 10 let in več, da preprečijo invazivno meningokokno bolezen, ki jo povzroča serotipa b neisseria meningitidis. uporaba tega cepiva mora biti v skladu z uradnimi priporočili.

Evropska unija - slovenščina - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - drugi antineoplastiki - removab je indiciran za intraperitonealno zdravljenje malignih ascitesov pri bolnikih s pozitivnimi karcinomom epcam, pri katerih standardna terapija ni na voljo ali ni več izvedljiva.

Evropska unija - slovenščina - EMA (European Medicines Agency)

gsk vaccines s.r.l. - zunanjo membrano semenskih mešičkov iz neisseria meningitidis skupina b (sev nz 98/254), rekombinantne neisseria meningitidis skupina b fhbp fuzijski protein, rekombinantne neisseria meningitidis skupina b nada beljakovin, rekombinantne neisseria meningitidis skupina b nhba fuzijski protein - meningitis, meningokokni - meningococcal cepiva - aktivna imunizacija proti invazivni bolezni, ki jo povzročajo sevi neisseria meningitidis serogroup-b.

Evropska unija - slovenščina - EMA (European Medicines Agency)

gsk vaccines s.r.l. - konjugirano cepivo proti meningokokom skupine a, c, w-135 in y - immunization; meningitis, meningococcal - bakterijska cepiva - vialsmenveo je označen za aktivno imunizacijo otrok (od dveh let starosti), mladostnikom in odraslim na tveganje izpostavljenosti neisseria meningitidis skupine a, c, w135 in y, za preprečevanje invazivnih bolezni. uporaba tega cepiva mora biti v skladu z uradnimi priporočili.

Evropska unija - slovenščina - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinurija, paroksizmal - imunosupresivi - soliris je navedeno pri odraslih in otrocih za zdravljenje:paroxysmal nočne haemoglobinuria (pnh). dokazila o kliničnih koristi je dokazana pri bolnikih z haemolysis z klinični simptom(i) okvirni visoke aktivnosti bolezni, ne glede na to, transfuzijo zgodovine (glej poglavje 5. netipične haemolytic uremic sindrom (ahus). soliris je navedeno pri odraslih za zdravljenje:ognjevzdržni splošnih myasthenia gravis (gmg) pri bolnikih, ki so anti-receptorjev acetilholina (achr) protitelesa-pozitivna (glej poglavje 5. neuromyelitis optica spectrum disorder (nmosd) pri bolnikih, ki so anti-aquaporin-4 (aqp4) protitelesa-pozitivno z recidivno potek bolezni.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - druga zdravila na živčnem sistemu - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.