Euroopan unioni - suomi - EMA (European Medicines Agency)

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - valmisteet haavojen ja haavaumien hoitoon - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

Euroopan unioni - suomi - EMA (European Medicines Agency)

warner chilcott uk ltd. - testosteroni - seksuaaliset toimintahäiriöt, psykologinen - sukupuolihormonit ja genitaalijärjestelmään vaikuttavat aineet, - intrinsa on tarkoitettu kohtelu hypoaktiivisen seksuaalisen halun häiriö (hsdd) kahden oophorectomised- ja hysterectomised (kirurgisesti aiheuttama menopaussi) naiset saavat samanaikainen estrogeenihoito.

Euroopan unioni - suomi - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - systeemiset bakteerilääkkeet, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. on otettava huomioon viralliset ohjeet antibioottien tarkoituksenmukaisesta käytöstä.

Euroopan unioni - suomi - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lisäkilpirauhashormoni - hypoparatyreoosi - kalsiumin homeostaasi - natpar on ilmoitettu lisähoitona aikuispotilailla, joilla on krooninen hypoparathyroidism joka ei voida asianmukaisesti hallita tavanomaista hoitoa yksin.

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)

ferring pharmaceuticals a/s - follitropiini delta - anovulation - sukupuolihormonit ja genitaalijärjestelmään vaikuttavat aineet, - ohjattu munasarjojen stimulaatiota kehittämiseksi useiden munarakkuloiden naisten käynnissä avusteiset lisääntymismenetelmät (art) kuten koeputkihedelmöitys (ivf) tai siittiön injektio (icsi) aikana.

Euroopan unioni - suomi - EMA (European Medicines Agency)

idorsia pharmaceuticals deutschland gmbh - daridorexant hydrochloride - unihäiriöiden ja ylläpidon häiriöt - psyykenlääkkeiden - quviviq is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan pharmaceuticals limited - duloksetiini - neuralgia; diabetic neuropathies; depressive disorder, major; anxiety disorders - psychoanaleptics, - kohtelu masennustila;hoito perifeerisen diabeettisen neuropatiakivun;yleistyneen ahdistuneisuushäiriön hoito;duloxetine mylan on tarkoitettu aikuisten.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Suomi - suomi - Fimea (Suomen lääkevirasto)

dsm sinochem pharmaceuticals nethelands bv - amoxicillinum trihydricum - dispergoituva tabletti - 750 mg - amoksisilliini