Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - vildagliptiini, metformiinihydrokloridia - diabetes mellitus, tyyppi 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 ja 5. 1 käytettävissä olevista tiedoista eri yhdistelmistä).

Euroopan unioni - suomi - EMA (European Medicines Agency)

jenson pharmaceutical services limited - dekstrometorfaani, kinidiini - neurobehavioral ilmenemismuodot - muut hermoston huumeet - nuedexta on tarkoitettu aikuisten pseudobulbaari-vaikutuksen (pba) oireenmukaiseen hoitoon. tehoa on tutkittu vain potilailla, joilla on amyotrofinen lateraaliskleroosi tai multippeliskleroosi.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited  - vildagliptiini, metformiinihydrokloridia - diabetes mellitus, tyyppi 2 - diabeetilla käytettävät lääkkeet - zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.

Euroopan unioni - suomi - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - kystinen fibroosi - muut hengitysteiden tuotteet - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Euroopan unioni - suomi - EMA (European Medicines Agency)

nova laboratories ireland limited - hydroksikarbamidi - anemia, sickle cell - antineoplastiset aineet - ehkäisy vaso-okklusiiviseen komplikaatioita sirppisoluanemia potilailla, jotka olivat yli 2-vuotiaille.

Euroopan unioni - suomi - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunosuppressantit - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Euroopan unioni - suomi - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - hiv-infektiot - antiviraalit systeemiseen käyttöön - atatsanaviiri mylan, co-pieniannoksisen ritonaviirin kanssa on tarkoitettu hiv-1-tartunnan saaneille aikuisille ja lapsipotilaille suositellaan 6-vuotiaille ja sitä vanhemmille yhdessä muiden antiretroviraalisten lääkevalmisteiden. perustuu käytettävissä virologinen ja kliininen tietoja aikuisille potilaille, mitään hyötyä ei ole odotettavissa potilailla, joilla on kantoja, jotka kestävät useita proteaasi-inhibiittoreita (≥ 4 pi-mutaatiota). alle 6-vuotiaille alle 18-vuotiaille lapsille on hyvin vähän tietoja. valinta atatsanaviiri mylan-hoitoa kokenut aikuis-ja lapsipotilailla olisi perustuttava yksittäisten virusresistenssitestauksen ja potilaan hoidon historia.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - immunosuppressantit - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. nivelpsoriaasin arthritiscosentyx, yksin tai yhdessä metotreksaatin (mtx), on tarkoitettu hoitoon aktiivisen psoriaasiartriitin hoitoon aikuisilla silloin, kun vaste aikaisempiin disease modifying anti-rheumatic lääke (dmard) hoito on ollut riittämätöntä. aksiaalinen spondyloartriitti (axspa)selkärankareuma (as, radiograafinen aksiaalinen spondyloartriitti)cosentyx on tarkoitettu hoitoon aktiivisen selkärankareuman hoitoon aikuisilla, jotka ovat vastanneet huonosti tavanomaiseen hoitoon. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan pharmaceuticals limited - duloksetiini - neuralgia; diabetic neuropathies; depressive disorder, major; anxiety disorders - psychoanaleptics, - kohtelu masennustila;hoito perifeerisen diabeettisen neuropatiakivun;yleistyneen ahdistuneisuushäiriön hoito;duloxetine mylan on tarkoitettu aikuisten.