Europska Unija - hrvatski - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - antineoplastična sredstva - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Europska Unija - hrvatski - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psorijaza - imunosupresivi - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplazme jajnika - antineoplastična sredstva - jajnika cancerlynparza prikazan kao monoterapija za:podržava liječenje odraslih bolesnika s поздними (figo faze iii i iv) u genima brca1/2-mutirani (зародышевой linije i/ili somatskih) brzorezni epitela jajnika, masterbatch cijevi ili primarni перитонеальный rak, koji u odgovor (potpuno ili djelomično) nakon završetka prve linije na bazi platine kemoterapije. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 i 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacijenti moraju prethodno bile tretirane s антрациклина i таксана u (neo)adjuvantne ili метастатический, ako pacijenti nisu prikladni za tih postupaka (vidi odjeljak 5. pacijenti s receptore hormona (h)-pozitivnog raka dojke treba također razvili ili nakon pre-hormonska terapija, ili se smatraju neprikladnim za endokrine terapije. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly nederland b.v. - ramucirumab - neoplazme želuca - antineoplastična sredstva - cancercyramza želuca u kombinaciji s paklitaksel je indiciran za liječenje odraslih bolesnika s rakom želuca ili gastro-пищеводная аденокарцинома veze s napredovanje bolesti nakon prethodnog platine i fluoropyrimidine kemoterapije. cyramza монотерапия indiciran za liječenje odraslih bolesnika s rakom želuca ili gastro-пищеводный razdvajanje аденокарцинома s napredovanje bolesti nakon prethodnog platine ili fluoropyrimidine kemoterapije, za koje je terapija u kombinaciji s паклитакселом ne odgovara. cancercyramza debelog crijeva, u kombinaciji s folfiri (иринотекан, фолиновой kiselina i 5‑fluorouracil), indiciran za liječenje odraslih bolesnika s metastaze колоректальным raka (mcrc) s napredovanje bolesti tijekom ili nakon prethodne terapije бевацизумабом, Оксалиплатин i fluoropyrimidine. non-mali cancercyramza pluća stanice u kombinaciju sa docetaxel indiciran za liječenje odraslih bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća s napredovanje bolesti nakon kemoterapije платиносодержащей. Гепатоцеллюлярная carcinomacyramza монотерапия indiciran za liječenje odraslih bolesnika s preliminarnim ili operirati гепатоцеллюлярной karcinom, koji imaju u serumu, alfa-фетопротеина (АФП) iznosi ≥ 400 ng/ml, a koje su prethodno liječenih Сорафениб.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences international ltd  - emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - eviplera je indiciran za liječenje odraslih okužen sa virus humane imunodeficijencije tipa 1 (hiv-1) bez poznatih mutacija povezanih s rezistencijom na nenukleozidne reverzne transkriptaze (nnrti) inhibitora klasa, tenofovir ili emtricitabin, i uz virusne opterećenja ≤ 100 000 hiv-1 rna kopija/ml. kao i kod drugih antiretrovirusnih lijekova, genotipske otpor testiranja i/ili povijesnih otpora podataka treba voditi korištenje eviplera.

Europska Unija - hrvatski - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - afatinib - karcinom, ne-malih stanica pluća - antineoplastična sredstva - giotrif u monoterapiji namijenjen za liječenje ofepidermal ako uređaj primatelja faktor rasta (РЭФР) тки-naivnih odraslih pacijenata sa lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća (НМРЛ) koja aktivira mutacije РЭФР (- s);lokalno-uobičajena ili metastatskih НМРЛ pločastih stanica гистологии napreduje ili nakon kemoterapije платиносодержащей.

Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - ambrisentan - hipertenzija, plućna - Гипотензивные, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - imunosupresivi - molimo pogledajte odjeljak 4. 1 sažetak značajki proizvoda u dokumentu o informacijama o proizvodu.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - karcinom, ne-malih stanica pluća - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multipli mijelom - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.