Европейский союз - финский - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft hylkääminen - immunosuppressantit - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Европейский союз - финский - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudiini ja raltegraviiri kaliumia - hiv-infektiot - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis on tarkoitettu käytettäväksi yhdessä muiden anti‑retroviral lääkkeiden hoitoon infektio immuunikatoviruksen (hiv‑1) aikuiset, nuoret ja lapset alle 6 vuotta ja painaa vähintään 30 kg ilman nykyisin tai aiemmin näyttöä viral vastustuskyvyn viruslääkkeiden oikeussuojakeinoista (integraasientsyymin strand siirtää estäjä) ja nrti (nucleoside käänteiskopioijaentsyymin estäjä) luokat (ks. kohdat 4. 2, 4. 4 ja 5.

Европейский союз - финский - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - diabeetilla käytettävät lääkkeet - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 ja 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Европейский союз - финский - 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.

Финляндия - финский - Fimea (Suomen lääkevirasto)

aspen pharma trading limited - azathioprine - tabletti, kalvopäällysteinen - 50 mg - atsatiopriini

Финляндия - финский - Fimea (Suomen lääkevirasto)

aspen pharma trading limited - azathioprine - tabletti, kalvopäällysteinen - 25 mg - atsatiopriini

Европейский союз - финский - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - diabeetilla käytettävät lääkkeet - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 ja 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Европейский союз - финский - EMA (European Medicines Agency)

nova laboratories ireland limited - 6-merkaptopuriinimonohydraattia - leukemia, lymfoidi - antineoplastiset aineet - xalupriini on tarkoitettu akuutin lymfoblastisen leukemian (all) hoitoon aikuisille, nuorille ja lapsille.

Европейский союз - финский - EMA (European Medicines Agency)

regeneron uk limited - rilonacept - cryopyrin liittyvien oireyhtymien - immunosuppressantit - rilonacept regeneron ilmoitetaan cryopyrin liittyvä kausittainen oireyhtymät (caps) hoitoon vakavia oireita, kuten familiaalinen kylmä auto tulehduksellinen oireyhtymä (fcas) ja muckle wells oireyhtymä (mws) aikuisilla ja 12 vuotiaat lapset ja vanhemmat.

Европейский союз - финский - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustaattia - glykogeenin varastointitaudin tyyppi ii - muut ruoansulatuskanavan ja aineenvaihduntatuotteet - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).