Euroopan unioni - suomi - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektiiviset immunosuppressantit - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd. - klormetiini - mycosis fungoides - antineoplastiset aineet - ledaga on tarkoitettu paikalliseen hoitoon mycosis fungoides-tyyppinen ihon taaksekallistuma (mf-tyyppi ctcl) aikuisilla.

Suomi - suomi - Fimea (Suomen lääkevirasto)

mylan ireland limited mylan ireland limited - bendamustinum hydrochloridum - kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos - 2.5 mg/ml - bendamustiini

Euroopan unioni - suomi - EMA (European Medicines Agency)

recordati rare diseases - osilodrostat fosfaatti - cushing-oireyhtymä - kortikosteroidit systeemiseen käyttöön - isturisa on tarkoitettu hoitoon endogeeninen cushingin oireyhtymä aikuisilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunosuppressantit - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Euroopan unioni - suomi - EMA (European Medicines Agency)

alnylam netherlands b.v. - patisiran natrium - amyloidoosi, perinnöllinen - muut hermoston huumeet - onpattro on tarkoitettu hoitoon perinnöllinen transthyretin-välitteisen amyloidoosi (hattr amyloidoosi) aikuisilla potilailla, joilla on vaiheen 1 tai vaiheen 2 polyneuropatia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sonidegib-difosfaatti - karsinooma, basal cell - antineoplastiset aineet - odomzo on tarkoitettu hoidettaessa aikuispotilaita, joilla on paikallisesti kehittynyt basesolukarsinooma (bcc), jotka eivät ole alttiita lääketieteelliselle leikkaukselle tai sädehoidolle.

Suomi - suomi - Fimea (Suomen lääkevirasto)

viatris oy - tobramycin - sumutinliuos - 300 mg / 5 ml - tobramysiini

Euroopan unioni - suomi - EMA (European Medicines Agency)

endoceutics s.a. - prasterone - postmenopause - muut sukupuolihormonit ja genitaalijärjestelmään vaikuttavat aineet - intrarosa on tarkoitettu vulvari- ja emättimen atrofian hoitoon postmenopausaalisilla naisilla, joilla on keskivaikeita tai vaikeita oireita.

Euroopan unioni - suomi - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatidi - osteoporosis; osteoporosis, postmenopausal - kalsiumin homeostaasi - teriparatide sun is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.