Keytruda האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

keytruda

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.

Stivarga האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

stivarga

bayer pharma ag - regorafenib - kolorektalne neoplazme - antineoplastic agents, protein kinase inhibitors - Стиварга prikazan kao monoterapija za liječenje odraslih bolesnika s metastaze колоректальным raka (КРР), koji su ranije već bili tretirani, ili ne smatraju se kandidatima za primjenjuju metode liječenja, a među njima fluoropyrimidine na temelju kemoterapije, anti-vegf terapije i anti-egfr terapije;неоперабельными ili метастатическими гастроинтестинальными стромальными tumora (ГИСО), koji su razvili ili netolerantan na liječenje imatinib i сунитиниб;гепатоцеллюлярная karcinom (hcc), koje su prethodno liječenih Сорафениб.

Oxaliplatin Pliva 5 mg/ml koncentrat za otopinu za infuziju קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

oxaliplatin pliva 5 mg/ml koncentrat za otopinu za infuziju

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - oksaliplatin - koncentrat za otopinu za infuziju - 5 mg/ml - urbroj: 1 ml koncentrata za otopinu za infuziju sadrži 5 mg oksaliplatina

Sinoxal 50 mg prašak za otopinu za infuziju; Sinoxal 100 mg prašak za otopinu za infuziju קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

sinoxal 50 mg prašak za otopinu za infuziju; sinoxal 100 mg prašak za otopinu za infuziju

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - oksaliplatin - prašak za otopinu za infuziju - 5 mg/ml - urbroj: 1 ml rekonstituirane otopine za infuziju sadrži 5 mg oksaliplatina

Zirabev האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

zirabev

pfizer europe ma eeig - bevacizumab - colorectal neoplasms; breast neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - zirabev u kombinaciji s fluoropyrimidine temelju kemoterapija prikazana za liječenje odraslih bolesnika s метастатической карциномой kolona ili rektuma. zirabev u kombinaciji s paklitaksel je indiciran za prva linija terapije kod odraslih pacijenata s metastaze raka dojke . za više informacija kao i za ljudsko receptor epidermalnog faktora rasta 2 (her2 i) status. zirabev, osim платин-na temelju kemoterapije, dizajniran je za prvu liniju terapije odraslih pacijenata s нерезектабельными-najčešće metastaze ili recidivom немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией. zirabev u kombinaciji s interferonom alfa-2a dizajniran za prvu liniju tretmana odraslih pacijenata s raširena i/ili metastaze почечно-клеточным raka. zirabev, 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.

Oxaliplatin Kabi 5 mg/ml koncentrat za otopinu za infuziju קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

oxaliplatin kabi 5 mg/ml koncentrat za otopinu za infuziju

fresenius kabi d.o.o., radnička cesta 37a, zagreb, hrvatska - oksaliplatin - koncentrat za otopinu za infuziju - 5 mg/ml - urbroj: 1 ml koncentrata za otopinu za infuziju sadrži 5 mg oksaliplatina

Eloxatin 5 mg/ml koncentrat za otopinu za infuziju קרואטיה - קרואטית - HALMED (Agencija za lijekove i medicinske proizvode)

eloxatin 5 mg/ml koncentrat za otopinu za infuziju

sanofi-aventis croatia d.o.o., heinzelova 70, zagreb, hrvatska - oxaliplatinum - koncentrat za otopinu za infuziju - 5 mg/ml - urbroj: 1 ml koncentrata za otopinu za infuziju sadrži 5 mg oksaliplatina

Aybintio האיחוד האירופי - קרואטית - EMA (European Medicines Agency)

aybintio

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. 1 of the smpc. aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. 1 of the smpc. aybintio, 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. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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 iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the smpc). aybintio, 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. aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. 1 of the smpc). aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the smpc).