Europeiska unionen - svenska - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuri, paroxysmal - selektiva immunsuppressiva medel - 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinuri, paroxysmal - immunsuppressiva - soliris är indicerat hos vuxna och barn för behandling av:paroxysmal nattlig haemoglobinuria (pnh). bevis på klinisk nytta som är visat att patienter med hemolys med kliniska symptom(s) tyder på en hög sjukdomsaktivitet, oavsett transfusion historia (se avsnitt 5. atypiska hemolytisk uremiskt syndrom (åhus). soliris är indicerat hos vuxna för behandling av:refraktära generaliserade myasthenia gravis (gmg) hos patienter som är anti-acetylkolin-receptorn (achr) antikropp-positiva (se avsnitt 5. neuromyelitis optica spectrum disorder (nmosd) hos patienter som är anti-akvaporin-4 (aqp4) antikropp-positiv med ett skovvis förlopp sjukdomen.

Europeiska unionen - svenska - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinuri, paroxysmal - immunsuppressiva - 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - hemoglobinuri, paroxysmal - immunsuppressiva - 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinuri, paroxysmal - immunsuppressiva - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). bevis på klinisk nytta som är visat att patienter med hemolys med kliniska symptom(s) tyder på en hög sjukdomsaktivitet, oavsett transfusion historia (se avsnitt 5.

Europeiska unionen - svenska - EMA (European Medicines Agency)

opk biotech netherlands bv - hemoglobinglutamer-200 (bovin) - blodsubstitut och infusionsvÄtskor - hundar - oxyglobin ger syrebärande stöd till hundar som förbättrar de kliniska tecknen på anemi under minst 24 timmar oberoende av det underliggande tillståndet.

Europeiska unionen - svenska - EMA (European Medicines Agency)

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

laboratorio reig jofre s.a. - pemetrexeddinatrium-2,5-hydrat - pulver till koncentrat till infusionsvätska, lösning - 500 mg - mannitol hjälpämne; pemetrexeddinatrium-2,5-hydrat 616,2 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

laboratorio reig jofre s.a. - pemetrexeddinatrium-2,5-hydrat - pulver till koncentrat till infusionsvätska, lösning - 100 mg - mannitol hjälpämne; pemetrexeddinatrium-2,5-hydrat 131,09 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

actavis group ptc ehf. - perindoprilarginin - filmdragerad tablett - 10 mg - laktosmonohydrat hjälpämne; perindoprilarginin 10 mg aktiv substans