Tecentriq Euroopa Liit - eesti - EMA (European Medicines Agency)

tecentriq

roche registration gmbh - atezolüsumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastilised ained - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq nagu monotherapy on näidustatud ravi täiskasvanud patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi pärast eelnevat keemiaravi. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq nagu monotherapy on näidustatud ravi täiskasvanud patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi pärast eelnevat keemiaravi. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Pemetrexed Baxter Euroopa Liit - eesti - EMA (European Medicines Agency)

pemetrexed baxter

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastilised ained - malignant pleural mesotheliomapemetrexed baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5. pemetrexed baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5. pemetrexed baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.

Elaprase Euroopa Liit - eesti - EMA (European Medicines Agency)

elaprase

takeda pharmaceuticals international ag ireland branch - idursulfaas - mukopolüsahhariidoos ii - muud alimentary seedetrakti ja ainevahetust tooted, - elaprase on näidustatud hunteri sündroomiga (mukopolüsahhariidoos ii, mps ii) patsientide pikaajaliseks raviks. kliinilistes uuringutes ei uuritud heterosügootseid emasid.

Faslodex Euroopa Liit - eesti - EMA (European Medicines Agency)

faslodex

astrazeneca ab - fulvestrant - rinnanäärmed - endokriinse ravi, anti-östrogeene - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. , pre - või perimenopausal naiste kombineeritud ravi palbociclib tuleks koos luteiniseeriva hormooni vabastav hormoon (lhrh) agonist.

Reconcile Euroopa Liit - eesti - EMA (European Medicines Agency)

reconcile

forte healthcare limited - fluoksetiin - psühhoanaleptikumid - koerad - kui abi ravi eraldamine seotud häired koertel avaldub hävitamine ja sobimatu käitumise (vocalisation ja sobimatu roojamine ja / või urineerimine) ja ainult koos käitumis-muutmise tehnikad.

Intuniv Euroopa Liit - eesti - EMA (European Medicines Agency)

intuniv

takeda pharmaceuticals international ag ireland branch - guanfatsiinvesinikkloriid - tähelepanupuudulikkuse häire koos hüperaktiivsusega - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv tuleb kasutada osana ulatuslikust adhd ravi programm, tavaliselt sealhulgas psühholoogilisi, pedagoogilisi ja sotsiaalseid meetmeid,.

Ivabradine Anpharm Euroopa Liit - eesti - EMA (European Medicines Agency)

ivabradine anpharm

"anpharm" przedsiębiorstwo farmaceutyczne s.a. - ivabradiin - angina pectoris; heart failure - muud kardiaalsed preparaadid - sümptomaatiline ravi kroonilise stabiilse stenokardia pectorisivabradine on näidustatud sümptomaatiline ravi kroonilise stabiilse stenokardia puhul südame isheemiatõbi täiskasvanud normaalse siinus rütm ja pulss on ≥ 70 l / min. ivabradine on näidustatud:täiskasvanud suuda taluda või contra-tähise kasutamise beeta-blockersor kombinatsioonis beeta-blokaatorite patsientidel, ebapiisavalt kontrollitud optimaalne annus betablocker. ravi kroonilise südame failureivabradine on näidustatud kroonilise südamepuudulikkuse nyha ii-iv klassi süstoolne düsfunktsioon, patsientidel, siinus rütm ning kelle südame löögisagedus on ≥ 75 l / min, koos standard ravi, sh beeta-blokaatorid ravi või kui beeta-blokaatorid ravi on vastunäidustatud või ei ole talutav.

Kalydeco Euroopa Liit - eesti - EMA (European Medicines Agency)

kalydeco

vertex pharmaceuticals (ireland) limited - ivakaftoor - tsüstiline fibroos - muud hingamisteede tooted - 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.