Imatinib Teva B.V. 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

imatinib teva b.v.

teva b.v. - иматиниба мезилат - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - imatinib-tewa b. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. pedijatrijska bolesnika s ph+ kml u fazi kroničnog neučinkovitosti interferon-alfa terapija, ili u ubrzanu fazu ili бластного kriza. za odrasle bolesnika s ph+ kml u бластный kriza. za odrasle i pedijatrijska bolesnika s prvi put utvrđenom pozitivnom akutne limfoblastične leukemije Филадельфийская kromosom (ph+ all) u kombinaciji s kemoterapijom. za odrasle pacijenata s relaps ili vatrostalne ph+ all u monoterapiji. za odrasle pacijente s миелодиспластический/миелопролиферативными bolesti (mds/rafinerija), povezanim sa бляшк-выведенное ako uređaj primatelja faktor rasta (pdgfr) promjena u kromosomu preustroj. za odrasle pacijente sa sindromom napredno гиперэозинофильный (hes) i/ili kronične eozinofilni leukemije (osobe) sa fip1l1-pdgfra preokret. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib-tewa b. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). u adjuvantne terapije odraslih pacijenata, koji su izloženi značajnim rizikom od recidiva nakon resekcije kit (cd117)-pozitivne suština. pacijenti koji imaju niske ili vrlo nizak rizik od recidiva, ne bi trebali primati adjuvantne terapije. liječenje odraslih bolesnika s метастатической выбухающей dermatofibrosarcoma (dfsp) i odraslih pacijenata s relaps i/ili метастатической dfsp, koji nemaju pravo na operaciju. u odrasle osobe i pedijatrijska bolesnika, učinkovitost иматиниба se temelji na zajedničkim гематологических i цитогенетических odgovora i preživljavanja bez progresije kod kml, na гематологический i цитогенетический odgovor cijene na ph+ all, mds/rafinerija, na гематологические indikatori odgovora u hes/cel i objektivnih odgovora kod odraslih pacijenata s неоперабельными i/ili метастатическими gist i dfsp i na безрецидивную stopa preživljavanja pri adjuvantne bit. iskustvo s иматинибом u bolesnika s mds/rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen. nema kontroliranih istraživanja pokazuju kliničku korist ili povećanje preživljavanja za te bolesti.

Braftovi 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

braftovi

pierre fabre medicament - encorafenib - melanoma; colorectal neoplasms - antineoplastična sredstva - encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, who have received prior systemic therapy.

Ayvakyt 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

ayvakyt

blueprint medicines (netherlands) b.v. - avapritinib - tumori gastrointestinalnog stroma - drugi antitumorski lijekovi, inhibitori протеинкиназы - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Equidacent 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

equidacent

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastična sredstva - bevacizumab u kombinaciji s kemoterapijom na bazi fluoropirimidina je indiciran za liječenje odraslih bolesnika s metastatskim karcinomom debelog crijeva ili rektuma. Бевацизумаб u kombinaciji s паклитакселом dizajniran za prvu liniju tretmana odraslih pacijenata s metastaze raka dojke . za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. Бевацизумаб u kombinaciji s капецитабином dizajniran za prvu liniju terapije bolesnika s metastaze raka dojke kod kojih je liječenje s drugim opcijama kemoterapije, uključujući таксаны ili антрациклины, smatra se neprikladnim. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Бевацизумаб u kombinaciji s эрлотинибом, prikazan je za prva linija terapije kod odraslih pacijenata s нерезектабельными-najčešće metastaze ili recidivom неороговевающий немелкоклеточного raka pluća s epidermalnog faktora rasta (egfr) aktiviraju mutacije. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. Бевацизумаб u kombinaciji s паклитакселом i цисплатином ili паклитакселом i топотеканом kod pacijenata koji ne mogu dobiti платиновую terapiju, indiciran za liječenje odraslih bolesnika s uporni, relaps ili метастатической карциномой grlića maternice.

Phesgo 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

phesgo

roche registration gmbh - pertuzumab, trastuzumab - neoplazme dojki - antineoplastična sredstva - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Trodelvy 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

trodelvy

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - antineoplastična sredstva - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Kimmtrak 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

kimmtrak

immunocore ireland limited - tebentafusp - uveal neoplasms - antineoplastična sredstva - kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (hla)-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Opdualag 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

opdualag

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Pemetrexed Baxter 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

pemetrexed baxter

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastična sredstva - 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.

Imjudo 欧盟 - 克罗地亚文 - EMA (European Medicines Agency)

imjudo

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.