Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen-cilag international n.v.   - macitentan - hypertensio, keuhkokuume - verenpainelääkkeet, - opsumit monoterapiana tai yhdistelmänä on tarkoitettu pulmonaalihypertensiota (pah) pitkäaikaiseen hoitoon who: n funktionaalisen luokan (fc) ii-iii aikuisilla potilailla. teho on osoitettu in pah väestöön, mukaan lukien idiopaattinen ja periytyviä pah, pah, johon liittyy sidekudoksen sairaudet, ja pah-korjattu yksinkertainen synnynnäinen sydänvika.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pharmathen s.a. - memantiinihydrokloridia - alzheimerin tauti - psychoanaleptics, , muut dementialääkkeet - alzheimerin taudin keskivaikean tai vaikean potilaan hoito.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - narkolepsia - muut hermoston huumeet - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - beclometasone dipropionate, formoteroli fumarate dihydraatti, glykopyrroniumbromidi - keuhkosairaus, krooninen obstruktiivinen - obstruktiivisten hengitystiesairauksien lääkkeet, - maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. copdmaintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5. asthmamaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - glycopyrronium bromide, indacaterol (acetate), mometasone furoate - astma - obstruktiivisten hengitystiesairauksien lääkkeet, - maintenance treatment of asthma in adults whose disease is not adequately controlled.

Euroopan unioni - suomi - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripipratsolia - skitsofrenia - psyykenlääkkeiden - skitsofrenian ylläpitohoito aikuisilla potilailla stabiloitui oraalisella aripipratsolilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

janssen cilag international nv - selexipag - hypertensio, keuhkokuume - antitromboottiset aineet - uptravi on tarkoitettu pitkän aikavälin hoitoa pulmonaalihypertensio (pah) aikuisilla kuka toiminnallinen luokka (fc) ii – iii, joko yhdistelmähoito potilailla, joilla on riittävästi hallinnassa endoteliini reseptorin antagonisti (era) ja/tai fosfodiesteraasi tyyppi 5 (pde-5) estäjä tai monoterapiana potilailla, jotka eivät ole hakeneet näitä hoitoja. teho on osoitettu in pah väestöön, mukaan lukien idiopaattinen ja periytyviä pah, pah, johon liittyy sidekudoksen sairaudet, ja pah-korjattu yksinkertainen synnynnäinen sydänvika.

Euroopan unioni - suomi - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - anagrelidi - trombosytemia, essential - antineoplastiset aineet - xagrid on merkitty vähentämistä kohonnut verihiutaleiden määrä riskiryhmään eteerinen thrombocythaemia (et) potilailla, jotka eivät siedä niiden nykyinen hoito tai joiden kohonnut verihiutaleiden ei vähennä hyväksyttävälle tasolle niiden nykyinen hoito. riski patientan at-risk et on määritelty yksi tai useampi seuraavista ominaisuuksista:>60-vuotias tai;verihiutaleiden määrä >1000 x 109/l;historia thrombohaemorrhagic tapahtumia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelidi hydrochloride - trombosytemia, essential - antineoplastiset aineet - anagrelidi on tarkoitettu vähentämään kohonnut verihiutaleiden määrän vaarassa essentiaalista trombosytemiaa (et) potilailla, jotka eivät siedä heidän nykyistä hoitoa tai joiden kohonnut trombosyyttiarvo ole vähennetty hyväksyttävälle tasolle niiden nykyinen hoito. an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.

Euroopan unioni - suomi - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - dermatiittiautia lukuun ottamatta kortikosteroideja - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.