Ultomiris Uniunea Europeană - română - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinurie, paroxismal - imunosupresoare selective - 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.

Epysqli Uniunea Europeană - română - EMA (European Medicines Agency)

epysqli

samsung bioepis nl b.v. - eculizumab - hemoglobinurie, paroxismal - imunosupresoare - 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.

Bekemv Uniunea Europeană - română - EMA (European Medicines Agency)

bekemv

amgen technology (ireland) uc - eculizumab - hemoglobinurie, paroxismal - imunosupresoare - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). dovezi de beneficii clinice este demonstrată la pacienții cu hemoliză cu simptom clinic(s) indică un grad înalt de activitate a bolii, indiferent de transfuzie istorie (a se vedea secțiunea 5.

Procomvax Uniunea Europeană - română - EMA (European Medicines Agency)

procomvax

sanofi pasteur msd, snc - polyribosylribitol fosfat de haemophilus influenzae tip b, ca prp-ompc, membrana exterioara complex de proteine de neisseria meningitidis (outer membrane protein complex de b11 tulpini de neisseria meningitidis subgrupul b) adsorbit, hepatita b antigen de suprafață recombinant produsă în celule de drojdie (saccharomyces cerevisiae) - hepatitis b; meningitis, haemophilus; immunization - vaccinuri - procomvax este indicat pentru vaccinare împotriva bolii invazive cauzate de haemophilus influenzae tip b şi impotriva infectiilor cauzate de toate subtipurile cunoscute ale virusului hepatitic b la nou-născuţi 6 săptămâni de la vârsta de 15 luni.

ROVAMYCINE 1,5 Mil. UI România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

rovamycine 1,5 mil. ui

famar lyon - franta - spiramycinum - compr. film. - 1,5 mil.u.i. - macrolide, lincosamide si streptogramine macrolide