Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan ireland limited - abirateroniasetaatti - prostatiset kasvaimet - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

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)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - kystinen fibroosi - muut hengitysteiden tuotteet - orkambi-tabletit on tarkoitettu kystisen fibroosin (cf) potilailla, jotka ovat iältään 6 vuotta ja vanhemmat, jotka ovat homotsygoottisia f508del-mutaation cftr geeni. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Suomi - suomi - Fimea (Suomen lääkevirasto)

jazz pharmaceuticals ireland limited - delta-9-tetrahydrocannabinol, cannabidiol, cannabis extract - sumute suuonteloon, liuos - kannabinoidit

Suomi - suomi - Fimea (Suomen lääkevirasto)

orion oyj - hydrocortisoni natrii succinas - injektiokuiva-aine - 100 mg - hydrokortisoni

Suomi - suomi - Fimea (Suomen lääkevirasto)

orion oyj - hydrocortisoni natrii succinas - injektiokuiva-aine - hydrokortisoni

Suomi - suomi - Fimea (Suomen lääkevirasto)

neofarma - hydrocortisonum - tabletti - 20 mg - hydrokortisoni

Suomi - suomi - Fimea (Suomen lääkevirasto)

neofarma - hydrocortisonum - tabletti - 10 mg - hydrokortisoni

Suomi - suomi - Fimea (Suomen lääkevirasto)

merck sharp & dohme b.v. - hydrocortisonum - emulsiovoide - 1 % - hydrokortisoni

Suomi - suomi - Fimea (Suomen lääkevirasto)

merck sharp & dohme b.v. - hydrocortisonum - voide - 1 % - hydrokortisoni