Raptiva Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

raptiva

serono europe limited - efalizumab - psoriaza - imunosupresivi - zdravljenje odraslih bolnikov z zmerno do hudo kronično psoriaze, ki se niso odzvali na ali ki so kontraindikacija za, ali so prenašali na druge sistemske terapije, vključno z ciklosporin se, metotreksatom in puva (glej oddelek 5. 1 - klinična učinkovitost).

Spevigo Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

spevigo

boehringer ingelheim international gmbh - spesolimab - psoriaza - imunosupresivi - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

Xolair Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

xolair

novartis europharm limited - omalizumab - asthma; urticaria - zdravila za obstruktivne pljučne bolezni, - alergijske asthmaxolair je navedeno pri odraslih, mladostnikih in otrocih (6 do.

Epysqli Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

epysqli

samsung bioepis nl b.v. - eculizumab - hemoglobinurija, paroksizmal - imunosupresivi - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Soliris Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

soliris

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.

Bekemv Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

bekemv

amgen technology (ireland) uc - eculizumab - hemoglobinurija, paroksizmal - imunosupresivi - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal 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.

Ultomiris Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

ultomiris

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.

Aspaveli Ευρωπαϊκή Ένωση - Σλοβενικά - EMA (European Medicines Agency)

aspaveli

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.