Evropska unija - slovenščina - EMA (European Medicines Agency)

alexion europe sas - sebelipaza alfa - lipidna metabolizem, urogenitalne napake - drugi zdravljene bolezni prebavil in presnove izdelki, - kanuma je indiciran za dolgoročno encimsko nadomestno terapijo (ert) pri bolnikih vseh starosti z lizosomsko kislinsko lipazo (lal).

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)

alexion europe sas - asfotaza alfa - hipofosfatazija - drugi zdravljene bolezni prebavil in presnove izdelki, - strensiq je indicirano za dolgotrajno encimska nadomestna terapija pri bolnikih s pediatrijo nastopom hypophosphatasia za zdravljenje kosti manifestacije bolezni.

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.

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

alexion europe s.a.s. - koncentrat za raztopino za infundiranje - -

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - andexanet alfa - drog stranske učinke in neželene učinke - vsi drugi terapevtski izdelki - pri odraslih bolnikih z neposrednim faktorja xa (fxa) serotonina (apixaban ali rivaroxaban), ko odprave antikoagulacijo je potrebna zaradi smrtno nevarno ali nenadzorovana krvavitev.

Evropska unija - slovenščina - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - imepitoin - drugi antiepileptics, antiepileptics - psi - za zmanjšanje pogostnosti splošnih napadov zaradi idiopatske epilepsije pri psih za uporabo po skrbni oceni alternativnih možnosti zdravljenja.

Evropska unija - slovenščina - EMA (European Medicines Agency)

clinuvel europe limited - afamelanotid - protoporfrija, eritropoetik - sproščevalce in zaščitne predmete - preprečevanje fototoksičnosti pri odraslih bolnikih z eritropoetično protoporfirijo (epp).

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

injekcije

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

injekcije