Europska Unija - hrvatski - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib-tewa indiciran za liječenje ofadult i pedijatrijska bolesnika s je prvi put dijagnosticiran Филадельфийской hromozoma (na bcr‑abl), koji je pozitivan (ph+) kronične mijeloične leukemije (kml), za koje je transplantacija koštane srži ne smatra se kao prva linija liječenja. za odrasle i pedijatrijska bolesnika s ph+ kml u fazi kroničnog neučinkovitosti interferon‑alfa terapija, ili u ubrzanu fazu ili бластного kriza. i pedijatrijski bolesne odrasle osobe 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. odraslih pacijenata s миелодиспластический/миелопролиферативными bolesti (mds/rafinerija), povezanim sa бляшк-выведенное ako uređaj primatelja faktor rasta (pdgfr) promjena u kromosomu preustroj. kod odraslih pacijenata 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 teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacijenti koji imaju niske ili vrlo nizak rizik od recidiva, ne bi trebali primati adjuvantne terapije. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

Europska Unija - hrvatski - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing limited - mcloksikam - oxicams, anti-inflammatory and anti-rheumatic products, non-steroids - dogs; horses; cats; cattle; pigs - dogsalleviation upale i bolova u akutni i kronični mišićno-koštanog sustava u pasa. da bi se smanjila sobu za intenzivnu njegu bol i upalu nakon ortopedskih i operacije mekih tkiva. catsreduction postoperativni bol nakon овариогистерэктомии i male operacije mekih tkiva . ublažavanje blage do umjerene postoperativni bol i upale nakon kirurške intervencije kod mačaka, e. ortoza i operacije mekih tkiva . olakšanje boli i upale kod akutne i kronične bolesti mišićno-koštanog sustava kod mačaka. koristiti cattlefor prilikom akutne infekcije respiratornog odgovarajuće antibiotske terapije za smanjenje kliničkih znakova. za korištenje kod proljeva u kombinaciji s oralnu регидрационной terapija za smanjenje kliničkih znakova kod teladi u roku od jednog tjedna, u dobi i mladi, ne-mliječne krave. za pomoćnu terapiju u liječenju akutnog mastitisa, u kombinaciji s antibiotskom terapijom. koristiti pigsfor u неинфекционной bolestima mišićno-koštanog sustava za ublažavanje simptoma hromost i upale. za pomoćnu terapiju u liječenju puerperalne septikemije i toksemije (mastitis-metritis-agalaktia sindrom) s odgovarajućom terapijom antibioticima. za olakšanje postoperativne boli povezane s manjim mekim tkivom kao što je kastracija. horsesalleviation upale i olakšavanja boli u akutni i kronični mišićno-koštanog sustava kod konja. za olakšanje boli povezane s kolikom kolica.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - Пембролизумаб - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastična sredstva - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacijenata sa egfr ili ala pozitivnih tumora mutacije također treba primili таргетную terapiju prije dobivanja Кейтруда. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bayer ag  - vardenafil - poremećaj erekcije - urologicals - liječenje erektilne disfunkcije kod odraslih muškaraca. disfunkcija erekcije je nemogućnost postizanja ili održavanja erekcije penisa dovoljnog za zadovoljavajuće seksualne učinke. da bi levitra bio učinkovit, potrebno seksualnu stimulaciju . levitra se ne navodi za žene.

Europska Unija - hrvatski - EMA (European Medicines Agency)

actavis group ptc ehf - topotekan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastična sredstva - topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5. Топотекана u kombinaciji s цисплатином je indiciran u bolesnika s карциномой relaps grlića maternice nakon radioterapije i za pacijente sa fazi bolesti instituta svjetske banke . patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - Спрайсел indiciran za liječenje pedijatrijska bolesnika:prvi put otkrivene philadelphia kromosoma-pozitivan kroničnog миелоидного leukemije u fazi kroničnog (ph+ kml cp) ili ph+ kml usp stabilnost ili netrpeljivosti ranije terapiju, uključujući imatinib. nedavno dijagnosticiran, ph+ akutne limfoblastične leukemije (all) u kombinaciji s kemoterapijom. Спрайсел indiciran za liječenje odraslih bolesnika s je prvi put dijagnosticiran philadelphia kromosoma-pozitivan (ph+) kronične миелоидного leukemije (kml) u fazi kroničnog;kronične, ubrzani ili eksplozije fazi kml s inzulinska ili netrpeljivosti ranije terapiju, uključujući imatinib мезилат;ph+ akutne limfoblastične leukemije (all) i лимфоидных eksplozije kml pri otpornost ili nepodnošenje prethodne terapije. Спрайсел indiciran za liječenje pedijatrijska bolesnika s je prvi put dijagnosticiran ph+ kml u kroničnu fazu (ph+ kml-cp) ili ph+ kml-cp s tolerancije ili netrpeljivosti ranije terapiju, uključujući imatinib.

Europska Unija - hrvatski - EMA (European Medicines Agency)

therakind (europe) limited - metotreksat - arthritis, psoriatic; precursor cell lymphoblastic leukemia-lymphoma; psoriasis; arthritis, rheumatoid; arthritis - antineoplastična sredstva - u ревматологические i dermatološki diseasesactive reumatoidni artritis kod odraslih pacijenata. polyarthritic oblika aktivnog, teška juvenilni idiopatska artritisa (ЮИА) kod djece i adolescenata u dobi od 3 i više godina, kada je reakcija na nesteroidni protuupalni lijekovi (nsar) je neadekvatna.. težak, tretman-тугоплавкий, isključivanje psorijaza, koji nije dovoljno odgovoriti na drugi oblici terapije, kao što su fototerapija, псоралена i uv zračenja (puva) terapija i retinoidi, i teška psorijatični artritis kod odraslih pacijenata. u oncologymaintenance liječenje akutnih лимфобластного leukemije (all) kod odraslih, djece i adolescenata u dobi od 3 i više godina.

Europska Unija - hrvatski - EMA (European Medicines Agency)

les laboratoires servier - pegaspargase - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - oncaspar je indiciran kao sastavni dio antineoplastic kombinirana terapija u akutnom limfoblastičnom leukemijom (all) u pedijatrijskih bolesnika od rođenja do 18 godina i odraslih bolesnika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly netherlands - pemetrekseda - carcinoma, non-small-cell lung; mesothelioma - antineoplastična sredstva - kancerogen плевральный mesotheliomapemetrexed lilly u kombinaciji s цисплатином indiciran za liječenje naivne kemoterapije u bolesnika s operirati raka mesothelioma плевры. Немелкоклеточного pluća cancerpemetrexed lilly u kombinaciji s цисплатином indiciran za prvu liniju terapije bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией. Пеметрексед lilly prikazan kao monoterapija za liječenje местнораспространенного ili метастатического немелкоклеточного raka pluća, druge, nego pretežno плоскоклеточного гистологии kod pacijenata, bolest kojoj se ne прогрессировало odmah nakon kemoterapije платиносодержащей. Пеметрексед lilly prikazan kao monoterapija za drugu liniju terapije kod bolesnika sa lokalno-održao ili метастатического немелкоклеточного raka pluća druge, nego u osnovi плоскоклеточной гистологией.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz gmbh - pemetreksed dinatrij hemipentahidrat - carcinoma, non-small-cell lung; mesothelioma - antineoplastična sredstva - maligni mesothelioma плевры Пеметрексед Сандоз u kombinaciji s цисплатином indiciran za liječenje naivne kemoterapije u bolesnika s operirati raka mesothelioma плевры. non-mali rak pluća stanice Пеметрексед Сандоз u kombinaciji s цисплатином indiciran za prva linija terapije u bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией. Пеметрексед Сандоз prikazan kao monoterapija za liječenje местнораспространенного ili метастатического немелкоклеточного raka pluća, druge, nego pretežno плоскоклеточного гистологии kod pacijenata, bolest kojoj se ne прогрессировало odmah nakon kemoterapije платиносодержащей. Пеметрексед Сандоз prikazan kao monoterapija za drugu liniju liječenja bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией.