Europäische Union - Finnisch - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabiini - prekursori t-solulymfoblastinen leukemia-lymfooma - antineoplastiset aineet - nelarabiini on tarkoitettu niiden potilaiden hoitoon akuutin t-lymfoblastisen leukemian (t-all) ja t-lymfoblastisen lymfooman (t-lbl), joiden tauti ei ole reagoinut tai on uusiutunut hoidon jälkeen vähintään kaksi solunsalpaajahoito. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Europäische Union - Finnisch - EMA (European Medicines Agency)

medimmune llc - reassortant influenssa virus (elävä heikennetty) seuraavista viruskannoista:a/california/7/2009 (h1n1)pdm09-kaltainen kanta, a/victoria/361/2011 (h3n2) - kaltainen kanta, b/massachusetts/2/2012-kaltainen kanta - influenza, human; immunization - rokotteet - profylaksia influenssan yksilöiden 24 kk alle 18-vuotiaat. fluenz-valmisteen käytön tulisi perustua virallisiin suosituksiin.

Europäische Union - Finnisch - EMA (European Medicines Agency)

astrazeneca ab - a/darwin/9/2021 (h3n2) - like strain (a/norway/16606/2021, medi 355293) / a/victoria/2570/2019 (h1n1)pdm09 - like strain (a/victoria/1/2020, medi 340505) / b/austria/1359417/2021 - like strain (b/austria/1359417/2021, medi 355292) / b/phuket/3073/2013 - like strain (b/phuket/3073/2013, medi 306444) - influenssa, ihminen - influenssa influenssa, elävä heikennetty - prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. fluenz tetran käytön olisi perustuttava virallisiin suosituksiin.

Europäische Union - Finnisch - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, trombosytopeeninen, idiopaattinen - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 ja 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 ja 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Europäische Union - Finnisch - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - astma - obstruktiivisten hengitystiesairauksien lääkkeet, - fasenra on merkitty add huolto hoito aikuisilla potilailla, joilla on vaikea eosinofiilinen astma on riittävästi hallinnassa huolimatta korkea-annos inhaloitavat kortikosteroidit plus pitkävaikutteista β-agonistit.

Europäische Union - Finnisch - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - antiviraalit systeemiseen käyttöön - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

Europäische Union - Finnisch - 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.

Europäische Union - Finnisch - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolaktoni - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 ja 5.

Europäische Union - Finnisch - EMA (European Medicines Agency)

bavarian nordic a/s - muunnettu vaccinia ankara - baijerin pohjoismainen (mva-bn) -virus - smallpox vaccine; monkeypox virus - muut virusrokotteet, - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4. 4 ja 5. käyttö tämä rokote tulee virallisten suositusten mukaisesti.

Europäische Union - Finnisch - EMA (European Medicines Agency)

prevtec microbia gmbh - elävä ei-patogeeninen escherichia coli o8: k87 - immunologicals for suidae, live bacterial vaccines, pig - siat - aktiivinen immunisointi sikoja vastaan enterotoksigeeninen f4-positiivista escherichia coli, jotta voidaan vähentää esiintyvyys on kohtalainen tai vaikea post-vieroituksen escherichia coli-bakteerin aiheuttama ripuli (pwd) sioilla;vähentää asuttaminen sykkyräsuoli ja fekaaliset irtoaminen enterotoksigeeninen f4-positiivista escherichia coli-tartunnan saaneiden sikojen.