Norvegia - norvegese - Statens legemiddelverk

cheplapharm arzneimittel gmbh - kvetiapinfumarat - depottablett - 400 mg

Unione Europea - norvegese - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuri, paroksysmal - selektive immunosuppressiva - 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.

Norvegia - norvegese - Statens legemiddelverk

medical valley invest ab - kvetiapinfumarat - depottablett - 300 mg

Norvegia - norvegese - Statens legemiddelverk

medical valley invest ab - kvetiapinfumarat - depottablett - 50 mg

Norvegia - norvegese - Statens legemiddelverk

medical valley invest ab - kvetiapinfumarat - depottablett - 150 mg

Norvegia - norvegese - Statens legemiddelverk

medical valley invest ab - kvetiapinfumarat - depottablett - 200 mg

Norvegia - norvegese - Statens legemiddelverk

medical valley invest ab - kvetiapinfumarat - depottablett - 400 mg

Unione Europea - norvegese - EMA (European Medicines Agency)

idorsia pharmaceuticals deutschland gmbh - daridorexant hydrochloride - søvninitiasjon og vedlikeholdssykdommer - psykoleptiske - quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

Unione Europea - norvegese - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - hemoglobinuri, paroksysmal - immunsuppressive - 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.

Unione Europea - norvegese - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinuri, paroksysmal - immunsuppressive - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). dokumentasjon av klinisk nytte er vist hos pasienter med haemolysis med kliniske symptom(s) en indikasjon på høy sykdomsaktivitet, uavhengig av transfusjon historie (se punkt 5..