Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

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.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - paklitaksela - breast neoplasms; pancreatic neoplasms; carcinoma, non-small-cell lung - antineoplastična sredstva - abraxane монотерапия indiciran za liječenje метастатического raka dojke kod odraslih pacijenata, koji ne prizemlju, kuhinju, blagovaonu-linija za obradu metastatic bolesti, a za koga standardni, антрациклин-sadrži terapija nije naveden. abraxane u kombinaciji s гемцитабин indiciran za prva linija terapije kod odraslih pacijenata s метастатической gušterače adenokarcinom gušterače. abraxane u kombinaciji s карбоплатином indiciran za prvu liniju liječenja немелкоклеточного raka pluća kod odraslih pacijenata koji nisu kandidati na potencijalno ljekovita kirurgije i/ili radioterapije.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastična sredstva - hormon-receptor pozitivnim čest grudi cancerafinitor indiciran za liječenje hormon-receptor pozitivan, i her2/neu-negativan preliminarnim raka dojke, u kombinaciji s exemestane, u post-menopausal žene bez simptomatske brutalna patologije nakon recidiva ili progresije bolesti nakon non-steroidal i abs битор. Нейроэндокринные tumora gušterače originafinitor indiciran za liječenje operirati ili метастатической, dobro ili umjereno diferencirani нейроэндокринные tumora gušterače podrijetla u odraslih s прогрессирующим bolest. Нейроэндокринные tumora gastrointestinalnog trakta ili pluća originafinitor indiciran za liječenje operirati ili метастатической dobro diferenciranih (klase 1 ili klase 2) нефункционирующие нейроэндокринные tumora gastrointestinalnog ili plućne bolesti podrijetla u odraslih s прогрессирующим bolest. Почечно-stanični carcinomaafinitor indiciran za liječenje bolesnika s prevladava почечно-stanica karcinoma, bolesti koje развивало nakon obrade na vegf-таргетной terapija.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

baxter holding b.v. - doksorubicin hidroklorid - sarcoma, kaposi; multiple myeloma; ovarian neoplasms; breast neoplasms - antineoplastična sredstva - caelyx пегилированный liposomal glasi:kao monoterapija u bolesnika s metastaze raka dojke, gdje postoji povećan rizik od srčanih bolesti., za liječenje popularnog raka jajnika kod žena koje nisu uspjeli u prvoj liniji na bazi platine kemoterapije terapije, u kombinaciji s бортезомибом za liječenje progresivne multiple myeloma kod bolesnika koji su primili barem jedan tečaj terapija i koji su već prošli ili neprikladan za transplantacije koštane srži;za liječenje povezanih sa aids-om kaposijev sarkom (sk) u bolesnika s niskim cd4 (.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

merck europe b.v.  - cetuksimab - head and neck neoplasms; colorectal neoplasms - antineoplastična sredstva - erbitux indiciran za liječenje bolesnika s receptor epidermalnog faktora rasta (РЭФР)-izraz, rasa divljeg tipa метастатический колоректальный rak:u kombinaciji s иринотеканом temelju kemoterapije;u prvoj liniji u kombinaciji s folfox;kao monoterapija kod bolesnika koji ne Оксалиплатин - i иринотекан-terapija i koji нетерпим na иринотекану. dodatne informacije potražite u odjeljku 5. erbitux indiciran za liječenje bolesnika s плоскоклеточным raka glave i vrata u kombinaciji sa terapijom zračenja pri lokalno-najčešće bolesti;u kombinaciji s kemoterapijom na bazi platine za relaps i/ili метастатической bolesti.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

roche registration gmbh - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastična sredstva - grudi cancermetastatic grudi cancerherceptin indiciran za liječenje bolesnika s her2 pozitivnim metastaze raka dojke:u monoterapiji za liječenje pacijenata koji su primili najmanje dva načina kemoterapije za метастатической bolesti. prije kemoterapije moraju biti uključena barem антрациклина i таксана, ako pacijenti nisu prikladni za tih postupaka. hormon-receptor-pozitivnih bolesnika također mora biti hormonske terapije, ako pacijenti nisu prikladni za takav tretman, u kombinaciji s паклитакселом za liječenje onih pacijenata koji nisu primili kemoterapiju za метастатической bolesti i za koga антрациклиновый ne odgovara;u kombinaciju sa docetaxel za liječenje bolesnika koji nisu primali kemoterapiju za метастатической bolesti;u kombinaciji s inhibitor aromataze za liječenje pacijenata u postmenopauzi s hormon-receptor pozitivnim metastaze raka dojke, ne ranije liječenih трастузумаб. rano majčino cancerherceptin indiciran za liječenje bolesnika s her2 pozitivnim rani rak dojke:nakon operacije, kemoterapije (неоадъювантной ili adjuvantne) i radioterapije (ako je primjenjivo);nakon adjuvantne kemoterapije doksorubicin i ciklofosfamid, u kombinaciji s паклитакселом ili docetaxel, u kombinaciji s adjuvantne kemoterapije, koji se sastoji od доцетаксела i карбоплатина;u kombinaciji s неоадъювантной kemoterapije, nakon čega slijedi adjuvantne terapije Герцептин, za lokalno-popularnog (uključujući i upalne bolesti ili tumora >2 cm u promjeru. Герцептин treba koristiti samo u bolesnika s metastaze ili ranog raka dojke, tumora kojih je bilo her2 i гиперэкспрессии ili амплификации gena her2, kako se određuje točan i dokazani анализами. Метастатические cancerherceptin želuca u kombinaciji s Капецитабин ili 5-fluorouracil i cisplatine indiciran za liječenje bolesnika s her2 pozitivnog метастатического raka želuca ili пищеводно-želučani tranzicije, koji nisu primili do antitumorski lijek метастатической bolesti. Герцептин treba koristiti samo u bolesnika s metastaze raka želuca, bolesti koje imaju гиперэкспрессию her2 i kako se određuje ihc2+ i prateću СИШ ili rezultat ribom, ili ihc3+ rezultat. treba koristiti točne i dokazane metode analize .

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - topotekan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - antineoplastična sredstva - hycamtin kapsule su indiciran kao monoterapija u liječenju odraslih bolesnika s relapsnim karcinom pluća malih stanica (sclc) kojima ponovno liječenje s prve linije režim ne smatra odgovarajućim. Топотекан indiciran za liječenje bolesnika s metastaze raka jajnika nakon neuspjeha prve linije ili naknadne terapije. hycamtin kapsule su indiciran kao monoterapija u liječenju odraslih bolesnika s relapsnim karcinom pluća malih stanica (sclc) kojima ponovno liječenje s prve linije režim ne smatra odgovarajućim.

Avrupa Birliği - Hırvatça - 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.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastična sredstva - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Avrupa Birliği - Hırvatça - EMA (European Medicines Agency)

teva b.v. - topotekan - ovarian neoplasms; 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. , 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 . pacijenti s preliminarnim utjecajem cisplatinu, zahtijevaju stalnu besplatno liječenje interval, da se opravda liječenje kombinacije.