Euroopan unioni - suomi - EMA (European Medicines Agency)

bavarian nordic a/s - vibrio cholerae, kanta cvd-103-hgr, live - kolera - rokotteet - vaxchora is indicated for active immunisation against disease caused by vibrio cholerae serogroup o1 in adults and children aged 2 years and older. tätä rokotetta on käytettävä virallisten suositusten mukaisesti.

Euroopan unioni - suomi - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - kystinen fibroosi - muut hengitysteiden tuotteet - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anemia, sickle cell - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Euroopan unioni - suomi - EMA (European Medicines Agency)

aimmune therapeutics ireland limited - defatted powder of arachis hypogaea l., semen (peanuts) - peanut hypersensitivity - allergens - palforzia is indicated for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. palforzia may be continued in patients 18 years of age and older. palforzia should be used in conjunction with a peanut-avoidant diet.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pacira ireland limited - bupivacaine - acute pain - amides, anesthetics, local - exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Euroopan unioni - suomi - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - emapalumab - immune system diseases - gamifant is indicated for the treatment of paediatric patients aged under 18 years with primary haemophagocytic lymphohistiocytosis (hlh).

Euroopan unioni - suomi - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - insuliini aspart - diabetes mellitus - diabeetilla käytettävät lääkkeet - kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Euroopan unioni - suomi - EMA (European Medicines Agency)

tetris pharma b.v - glukagonin - diabetes mellitus - haiman hormonit, hormonit glycogenolytic - ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

Euroopan unioni - suomi - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedeema, perinnöllinen - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Euroopan unioni - suomi - EMA (European Medicines Agency)

advicenne s.a. - potassium citrate monohydrated, potassium hydrogen carbonate - acidosis, renal tubular - mineral supplements - sibnayal is indicated for the treatment of distal renal tubular acidosis (drta) in adults, adolescents and children aged one year and older.