Europska Unija - hrvatski - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karcinom, squamous cell - antineoplastična sredstva - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - antianemijski pripravci - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Europska Unija - hrvatski - EMA (European Medicines Agency)

ge healthcare b.v. - ioflupan (123) - tomography, emission-computed, single-photon; lewy body disease; parkinson disease; alzheimer disease - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. kasnije je dizajniran za otkrivanje gubitka funkcionalnih дофаминергических neurona u стриатуме terminali:kod odraslih pacijenata sa klinički nesigurni Паркинсонического sindromi, na primjer, s početkom simptomima, kako bi se razlikovati эссенциальный tremor od parkinsonove bolesti sindromi povezani s idiopatske parkinsonove bolesti, прогрессирующем надъядерном paralize i multiple sistemske атрофией. kasnije ne može razlikovati između parkinsonove bolesti, множественную sistem gubljenje i прогрессирующем надъядерном paralize. kod odraslih pacijenata, kako bi razlikovati vjerojatno demencije s тельцами levy od alzheimerove bolesti . kasnije nije u stanju razlikovati demencije s тельцами levi i parkinsonove bolesti s demencijom.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - 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 i 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 i 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

esteve pharmaceuticals, s.a. - duloksetin - anxiety disorders; depressive disorder, major; diabetic neuropathies - psychoanaleptics, - liječenje velikog depresivnog poremećaja;liječenje dijabetičke periferne neuropatske boli;liječenje generalizirani anksiozni poremećaj;baikal je navedeno u odraslih.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - prostatske neoplazme - endokrinska terapija - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

cis bio international - ioflupan (123) - radionuclide imaging; dementia; movement disorders - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. striascan je dizajniran za otkrivanje gubitka funkcionalnih дофаминергических neurona u стриатуме terminali:kod odraslih pacijenata sa klinički nesigurni паркинсонического sindromi, na primjer, s početkom simptomima, kako bi se razlikovati эссенциальный tremor od parkinsonove bolesti sindromi povezani s idiopatske parkinsonove bolesti, прогрессирующем надъядерном paralize i multiple sistemske атрофией. striascan nije u stanju razlikovati bolest, parkinsonova bolest, множественную sistem gubljenje i прогрессирующем надъядерном paralize. kod odraslih pacijenata, kako bi razlikovati vjerojatno demencije s тельцами levy od alzheimerove bolesti . striascan nije u stanju razlikovati između demencijom s тельцами levi i parkinsonove bolesti s demencijom.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

krka farma d.o.o. sarajevo - risperidonskoj - filmom obložena tableta - 4 mg/1 tableta - 1 filmom obložena tableta sadrži: 4 mg risperidon

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

krka farma d.o.o. sarajevo - risperidonskoj - filmom obložena tableta - 3 mg/1 tableta - 1 filmom obložena tableta sadrži: 3 mg risperidon

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

krka farma d.o.o. sarajevo - risperidonskoj - filmom obložena tableta - 2 mg/1 tableta - 1 filmom obložena tableta sadrži: 2 mg risperidon