欧州連合 - クロアチア語 - 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.

欧州連合 - クロアチア語 - EMA (European Medicines Agency)

sandoz gmbh - ibandroninska kiselina - breast neoplasms; neoplasm metastasis; fractures, bone - pripravci za liječenje bolesti kostiju, bisfosfonatima - ibandronatna kiselina sandoz je indiciran za sprječavanje koštanih poremećaja (patološki prijelomi, komplikacije na kostima koje zahtijevaju radioterapiju ili operaciju) u bolesnika s dojke rak i koštanim metastazama.

欧州連合 - クロアチア語 - EMA (European Medicines Agency)

bayer ag - telmisartan, hydrochlorothiazide - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije. kinzalkomb s fiksnom kombinacijom doze (40 mg телмисартана / 12. 5 mg hidroklorotiazid, 80 mg телмисартана / 12. 5 mg hidroklorotiazid) prikazan pacijentima, kod kojih je krvni pritisak nije dovoljno prati na телмисартан sami. kinzalkomb s fiksnom kombinacijom doza (80 mg телмисартан / hidroklorotiazid 25 mg) prikazan pacijentima, kod kojih je krvni pritisak nije dovoljno prati na kinzalkomb (80 mg телмисартана / 12. 5 mg hidroklorotiazid) ili bolesnika, koji su prethodno bili su uhvaćeni na телмисартана ili hidroklorotiazid odvojeno.

欧州連合 - クロアチア語 - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - karcinom, ne-malih stanica pluća - Антинеопластические i иммуномодулирующие agenti, monoklonsko antitijelo - nivolumab bms je indiciran za liječenje lokalno avanziranog ili metastatskog skvamoznog ne-malih stanica raka pluća (nsclc) nakon prethodne kemoterapije kod odraslih.

欧州連合 - クロアチア語 - 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.

欧州連合 - クロアチア語 - EMA (European Medicines Agency)

nova laboratories ireland limited - 6-merkaptopurin monohidrat - leukemija, limfoid - antineoplastična sredstva - xaluprin je indiciran za liječenje akutne limfoblastične leukemije (all) u odraslih, adolescenata i djece.

欧州連合 - クロアチア語 - EMA (European Medicines Agency)

eli lilly nederland b.v. - necitumumab - karcinom, ne-malih stanica pluća - antineoplastična sredstva - portrazza u kombinaciji s gemcitabinom i cisplatinom kemoterapija je indicirana za liječenje odraslih bolesnika s lokalno uznapredovalim ili metastatskim epidermalnog čimbenika rasta receptora (egfr) izražava pločastih ne-malih stanica raka pluća ne primali kemoterapiju za ovo stanje.

欧州連合 - クロアチア語 - EMA (European Medicines Agency)

biogen netherlands b.v. - peginterferon beta-la - multipla skleroza - Иммуностимуляторы, - liječenje recidivnog remitiranja multiple skleroze u odraslih bolesnika.

欧州連合 - クロアチア語 - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - Ипилимумаб - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastična sredstva - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 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 (see sections 4. 4 i 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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%.

欧州連合 - クロアチア語 - 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.