Uniunea Europeană - suedeză - 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.

Uniunea Europeană - suedeză - EMA (European Medicines Agency)

n.v. organon - corifollitropin alfa - reproductive techniques, assisted; ovulation induction; investigative techniques - könshormoner och modulatorer av könsorganen, - controlled ovarian stimulation (cos) in combination with a gnrh antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (art) program. elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hcg).

Uniunea Europeană - suedeză - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - hiv-infektioner - antivirala medel för systemisk användning - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Uniunea Europeană - suedeză - EMA (European Medicines Agency)

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrheals, tarm -, antiinflammatoriska / antiinfective agenter - truberzi är indicerat hos vuxna för behandling av irritabelt tarmsyndrom med diarré (ibs d).

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

map medical technologies oy - natriumjodid(i-131) - oral vätska - 0,37-740 mbq/ml - natriumjodid(i-131) 0,37 - 740 mbq aktiv substans - natriumjodid(i-131)

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

map medical technologies oy - natriumjodid(i-131) - kapsel, hård - 37-7400 mbq - natriumjodid(i-131) 37 - 7400 mbq aktiv substans - natriumjodid(i-131)

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

orifarm ab - progesteron - vaginalgel - 8 % - progesteron 90 mg aktiv substans; sorbinsyra hjälpämne; glycerol hjälpämne - progesteron

Uniunea Europeană - suedeză - EMA (European Medicines Agency)

astrazeneca ab - andexanet alfa - drog-relaterade biverkningar och biverkningar - alla andra terapeutiska produkter - för vuxna patienter som behandlas med en direkt faktor xa (fxa) - hämmare (apixaban eller rivaroxaban) när återföring av antikoagulation som behövs på grund av livshotande eller okontrollerad blödning.

Uniunea Europeană - suedeză - EMA (European Medicines Agency)

amgen europe b.v. - darbepoetin alfa - anemia; cancer; kidney failure, chronic - andra preparat antianemic - behandling av symptomatisk anemi associerad med kroniskt njursvikt (crf) hos vuxna och barn. behandling av symtomgivande anemi hos vuxna cancerpatienter med icke-myeloida maligniteter får kemoterapi.

Uniunea Europeană - suedeză - EMA (European Medicines Agency)

alexion europe sas - sebelipas alfa - lipid metabolism, inborn fel - andra matsmältningsorgan och ämnesomsättning produkter, - kanuma är indicerat för långsiktig enzymersättningsbehandling (ert) för patienter i alla åldrar med brist på lysosomalt surt lipas (lal).