Eladynos Evropska unija - slovenščina - EMA (European Medicines Agency)

eladynos

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - kalcij homeostaza - zdravljenje osteoporoze pri ženskah po menopavzi pri večjem tveganju zloma.

Luxturna Evropska unija - slovenščina - EMA (European Medicines Agency)

luxturna

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna je indiciran za zdravljenje odraslih in pediatričnih bolnikih z izgubo vida zaradi dedne očesne mrežnice distrofija, ki jih povzročajo potrdili biallelic rpe65 mutacije in ki imajo dovolj preživetja celic mrežnice.

Kalydeco Evropska unija - slovenščina - EMA (European Medicines Agency)

kalydeco

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi dihal - 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 in 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 in 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.

Kaftrio Evropska unija - slovenščina - EMA (European Medicines Agency)

kaftrio

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistična fibroza - drugi proizvodi dihal - 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.

Bexsero suspenzija za injiciranje v napolnjeni injekcijski brizgi Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

bexsero suspenzija za injiciranje v napolnjeni injekcijski brizgi

gsk vaccines srl - beljakovina nhba iz neisseria meningitidis skupine b, rekombinantna, fuzijska, beljakovina nada iz neisseria meningitidis skupine b, rekombinantna, beljakovina fhbp iz neisseria meningitidis skupine b, rekombinantna, fuzijska, vezikli zunanje membrane iz neisseria meningitidis skupine b sev nz98/254 - suspenzija za injiciranje - beljakovina nhba iz neisseria meningitidis skupine b, rekombinantna, fuzijska 50 µg / 0,5 ml; beljakovina nada iz neisseria meningitidis skupine b, rekombinantna 50 µg / 0,5 ml; beljakovina fhbp iz neisseria meningitidis skupine b, rekombinantna, fuzijska 50 µg / 0,5 ml; vezikli zunanje membrane iz neisseria meningitidis skupine b sev nz98/254 25 µg / 0,5 ml - večkomponentno cepivo proti meningokokom b

Procomvax Evropska unija - slovenščina - EMA (European Medicines Agency)

procomvax

sanofi pasteur msd, snc - polyribosylribitol fosfat iz haemophilus influenzae tipa b, kot prp-ompc, zunanja membrana, beljakovine kompleks neisseria meningitidis (zunanje membrane protein complex v b11 sev neisseria meningitidis podskupini b), adsorbira hepatitis b surface antigen, proizvedene v rekombinantne kvasovke celic (saccharomyces cerevisiae) - hepatitis b; meningitis, haemophilus; immunization - cepiva - procomvax je indicirano za cepljenje proti invazivni bolezni, ki povzroča haemophilus influenzae tipa b in proti okužbi, zaradi vseh znanih podtipov virusa hepatitisa b pri dojenčkih 6 tednov do 15 mesecev starosti.

Xenical Evropska unija - slovenščina - EMA (European Medicines Agency)

xenical

cheplapharm arzneimittel gmbh - orlistat - debelost - preparati za zaščito proti sončenju, prehrambeni izdelki - xenical je navedena v povezavi z rahlo hypocaloric dieto za zdravljenje debelih bolnikov s a indeks telesne mase (itm) večje ali enako 30 kg/m2 ali bolniki prekomerno telesno težo (itm > 28 kg/m2) z povezanih dejavnikov tveganja. zdravljenje z orlistat, je treba prekiniti po 12 tednih, če bolniki niso mogli izgubiti vsaj 5% telesne teže, kot je izmerjena na začetku terapije.