Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - niveltulehdus, nivelreuma - immunosuppressantit - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 ja 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Euroopan unioni - suomi - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - niveltulehdus, nivelreuma - immunosuppressantit - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiantia voidaan käyttää monoterapiana tai yhdistelmänä metotreksaatin kanssa. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Suomi - suomi - Fimea (Suomen lääkevirasto)

baxalta innovations gmbh - tekijä viii: n estäjä ohittaen toimintaa - infuusiokuiva-aine ja liuotin, liuosta varten - 25 u/ml - hyytymistekijä viii:n vasta-aineen ohittava aine

Suomi - suomi - Fimea (Suomen lääkevirasto)

baxalta innovations gmbh - tekijä viii: n estäjä ohittaen toimintaa - infuusiokuiva-aine ja liuotin, liuosta varten - 50 u/ml - hyytymistekijä viii:n vasta-aineen ohittava aine

Euroopan unioni - suomi - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - kystinen fibroosi - muut hengitysteiden tuotteet - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 ja 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the 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. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 ja 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Euroopan unioni - suomi - EMA (European Medicines Agency)

cis bio international - depreotiditrifluoriasetaatti - radionuklidien kuvantaminen - diagnostiset radiofarmaseuttiset valmisteet - tämä lääkevalmiste on tarkoitettu vain diagnostiseen käyttöön. sillä skintigrafiset kuvantaminen epäillään pahanlaatuisia kasvaimia alkututkimuksen jälkeen, yhdessä kanssa tietokonetomografian tai keuhkoröntgenin kanssa potilailla, joilla on yksittäisiä keuhkonoduluksia.

Suomi - suomi - Fimea (Suomen lääkevirasto)

ge healthcare limited - kalsium trinatrii pentetas - valmisteyhdistelmä radioaktiivista lääkettä varten - 20.6 mg - teknetium(99mtc)pentetaatti

Suomi - suomi - Fimea (Suomen lääkevirasto)

cis bio international - albumin, human - valmisteyhdistelmä radioaktiivista lääkettä varten - 10 mg - ihmisen teknetium(99mtc) ihmisen albumiini

Suomi - suomi - Fimea (Suomen lääkevirasto)

cis bio international - calcium trisodium pentetate - valmisteyhdistelmä radioaktiivista lääkettä varten - teknetium(99mtc)pentetaatti

Suomi - suomi - Fimea (Suomen lääkevirasto)

cis bio international - dimercaptosuccinic acid - valmisteyhdistelmä radioaktiivista lääkettä varten - 1 mg - teknetium(99mtc)suksimeeri