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)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastična sredstva - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastična sredstva - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - karcinom, ne-malih stanica pluća - antineoplastična sredstva - tremelimumab astrazeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly nederland b.v. - inzulin glargin - Šećerna bolest - lijekovi koji se koriste u dijabetesu - liječenje dijabetes melitusa kod odraslih, adolescenata i djece u dobi od 2 godine i više.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafil - hipertenzija, plućna - urologicals - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. učinkovitost je pokazana u idiopatskom pah (ipah) i pah povezanoj na vaskularnu bolest kolagena. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ratiopharm gmbh - dcsloratadin - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistaminici za sistemsku primjenu, - desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician.

Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis b površinski antigen - hepatitis b; immunization - cjepiva - fendrix je indiciran u adolescenata i odraslih osoba u dobi od 15 godina pa nadalje za aktivnu imunizaciju protiv infekcije virusom hepatitisa b (hbv) uzrokovane svih poznatih podvrsta u bolesnika s bubrežnom insuficijencijom (uključujući pre-hemodijaliza i hemodijalizi bolesnika).

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (kao fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastična sredstva - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Полицитемия vjera (mf)jakavi indiciran za liječenje odraslih bolesnika s полицитемия vjera, koje su otporne na ili netoleranciju hidroksiurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ucb pharma sa - levetiracetam - epilepsija - antiepileptici sredstva, - keppra je indicirana kao monoterapija u liječenju parcijalnih napadaja sa ili bez sekundarne generalizacije u bolesnika od 16 godina starosti s novodijagnosticiranom epilepsijom. Кеппра drugačije kao pomoćna terapija u liječenju parcijalnih napadaja napad sa ili bez sekundarne generalizacije kod odraslih, djece i beba u dobi od jednog mjeseca epilepsije;u liječenju миоклонические grčevi kod odraslih i adolescenata od 12 godina, s maloljetnika миоклоническая epilepsija;u liječenju primarne генерализованных тонико-клонические napadaja kod odraslih i adolescenata od 12 godina starosti sa idiopatskom epilepsijom postati generalizirani.