Eiropas Savienība - latviešu - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - degarelix - prostatas audzēji - endokrīnā terapija - firmagon is a gonadotrophin releasing hormone (gnrh) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistiskā fibroze - other respiratory system products - 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 un 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 un 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - follitropin delta - anovulācija - dzimumhormoni un dzimumsistēmas modulatori dzimumorgānu sistēma, - kontrolētas olnīcu stimulācijas vairāku folikulu galīgās atbalstāmajos reproduktīvās tehnoloģijas (art), piemēram in vitro apaugļošanas (ivf) vai intracytoplasmic spermas injekcija (icsi) cikls sieviešu attīstībai.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistiskā fibroze - other respiratory system products - orkambi tabletes ir indicēts, lai ārstētu cistiskā fibroze (cf) pacientiem vecumā no 6 gadiem un vecākiem, kas ir homozygous par f508del cftr mutācija gēnu. 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zoledronic acid - lūzumi, kauls - zāles kaulu slimību ārstēšanai - profilakses skeleta saistīti notikumi (patoloģisku lūzumu, mugurkaula kompresiju, starojuma vai operācijas, kaulu, vai audzēja izraisītu hypercalcaemia) pieaugušiem pacientiem ar progresējošu ļaundabīgu audzēju, iesaistot kaulu;ārstēšana pieaugušiem pacientiem ar audzēju izraisītu hypercalcaemia (tih).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - cannabidiol - lennox gastaut syndrome; epilepsies, myoclonic - antiepileptics, - epidyolex ir norādīti izmantot kā adjunctive terapijas konfiskāciju, kas saistīts ar lennox gastaut sindroma (lgs) vai dravet sindroms (ds), kopā ar klobazāms, pacientiem 2 gadu vecuma un vecāki.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistiskā fibroze - other respiratory system products - 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomīds - multiplā skleroze, recidivējoši-pārskaitot - imūnsupresanti - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipine besilate, valsartan - hipertensija - agents, kas iedarbojas uz renīna-angiotenzīna sistēmu - esenciālas hipertensijas ārstēšana. amlodipine/valsartan mylan ir norādīts pieaugušajiem, kuru asinsspiedienu nevar pienācīgi kontrolēt uz amlodipine vai valsartan monotherapy.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psihoterapija - aripiprazole mylan pharma ir indicēts šizofrēnijas ārstēšanai pieaugušajiem un pusaudžiem vecumā no 15 gadiem. aripiprazole mylan pharma ir indicēts, lai ārstētu vidēji smagu vai smagu mānijas epizodes bipolāru i traucējumu un novērstu jaunas mānijas epizode pieaugušajiem, kas ir piedzīvojuši galvenokārt mānijas epizodes un kuru mānijas epizodes atbildēja uz aripiprazole ārstēšana. aripiprazole mylan pharma ir indicēts, lai ārstētu līdz 12 nedēļām par vidēji smagu vai smagu mānijas epizodes bipolāru i traucējumu pusaudžiem vecumā no 13 gadiem un vecāki.