Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateron acetat - prostatske neoplazme - endokrinska terapija - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan ireland limited - abirateron acetat - prostatske neoplazme - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Europska Unija - hrvatski - EMA (European Medicines Agency)

krka, d.d., novo mesto - abirateron acetat - prostatske neoplazme - endokrinska terapija - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

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)

bristol-myers squibb pharma eeig - Талидомид - multipli mijelom - imunosupresivi - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab ведотин - limfom, b-stanični - antineoplastična sredstva - Полевий u kombinaciji s Бендамустин i rituksimab je indiciran za liječenje odraslih bolesnika s ponavljajućom/uporan da bi se raspršili u-крупноклеточной limfoma (ДВККЛ), koji nisu kandidati za transplantaciju гемопоэтических transplantacija matičnih stanica. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Europska Unija - hrvatski - EMA (European Medicines Agency)

lipomed gmbh - Талидомид - multipli mijelom - imunosupresivi - thalidomide lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. thalidomide lipomed is prescribed and dispensed in accordance with the thalidomide lipomed pregnancy prevention programme (see section 4.

Europska Unija - hrvatski - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - docetaksel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastična sredstva - grudi cancerdocetaxel Каби u kombinaciji s doksorubicin i ciklofosfamid je indiciran za adjuvantne terapije pacijenata s:aktivni čvor-pozitivan rak dojke;aktivni čvor-negativnim rakom dojke . za pacijente s операбельным čvor-negativnim rakom dojke, adjuvantne terapije trebalo bi biti ograničeno pravo bolesnika na primanje kemoterapije po međunarodnim kriterijima na primarne terapije ranog raka dojke . Каби доцетаксел u kombinaciji s doksorubicin je namijenjen za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke, prethodno liječenih цитотоксической terapija za ovo stanje. Доцетаксел Каби monoterapija namijenjen je za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti terapije цитотоксической. prethodne kemoterapije moraju uključivati антрациклиновый ili алкилирующий agent. Каби доцетаксела u kombinaciji s трастузумабом namijenjen je za liječenje bolesnika s metastaze raka dojke, bolesti kojima je prisutna gena her2, a koji ranije nisu primali kemoterapiju o popularnog bolesti. Каби доцетаксела u kombinaciji s капецитабином namijenjen je za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti цитотоксической kemoterapije. prethodna terapija mora sadržavati антрациклиновый. non-mali-stanice cancerdocetaxel Каби pluća indiciran za liječenje bolesnika s местнораспространенным ili metastatskih немелкоклеточным od raka pluća neučinkovitosti ranije kemoterapije. Каби доцетаксела u kombinaciji s цисплатином namijenjen je za liječenje bolesnika s нерезектабельным, lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća kod pacijenata koji nisu prethodno tretirani i kemoterapiju za ove uvjete. prostate cancerdocetaxel kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. Доцетаксел Каби u kombinaciji s androgen-депривационная terapija (АДТ), sa ili bez преднизоном ili преднизолоном indiciran za liječenje bolesnika s metastaze hormon-senzitivni rak prostate . Želudac adenocarcinomadocetaxel Каби u kombinaciji s цисплатином i 5-фторурацилом namijenjen je za liječenje bolesnika s метастатической аденокарциномой želuca, uključujući i gušterače adenokarcinom пищеводно-želučani tranzicije, koji nisu primili ranije kemoterapije za метастатической bolesti. glava i vrat cancerdocetaxel Каби u kombinaciji s цисплатином i 5-фторурацилом dizajniran za indukcijska terapija bolesnika s lokalno-najčešći плоскоклеточным raka glave i vrata.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bayer ag - radium (223ra) dichloride - prostatske neoplazme - terapeutski radiofarmaceutski pripravci - xofigo je indiciran za liječenje odraslih osoba s karcinomom prostate otpornih na kastriranje, simptomatskim koštanim metastazama i bez poznatih visceralnih metastaza.

Europska Unija - hrvatski - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - imunosupresivi - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) indiciran za liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma koji se ne oslanja transplantacije. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) indiciran za liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma koji se ne oslanja transplantacije. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).