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)

roche registration gmbh - erlotinib - carcinoma, non-small-cell lung; pancreatic neoplasms - antineoplastična sredstva - Немелкоклеточный rak pluća (НМРЛ)Тарцева i ukazuje na popravak prekidača liječenja u bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća sa egfr aktiviranje перегласовки i stabilan bolesti nakon kemoterapije prvoj liniji. Тарцева je također indiciran za liječenje bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća nakon neuspjeha barem jedne prethodne kemoterapije shema. kod pacijenata s tumorima bez РСКФ aktiviraju mutacije, Тарцева drugačije, kada su druge mogućnosti liječenja ne raspravlja. prilikom imenovanja Тарцевы, čimbenike vezane uz dugotrajan opstanak treba uzeti u obzir. nikakva prednost opstanak ili drugi klinički značajne efekte liječenja su pokazali da je kod pacijenata sa epidermalnog faktora rasta (egfr)-ВВК - negativnih tumora. cancertarceva gušterače u kombinaciji s гемцитабином indiciran za liječenje bolesnika s metastaze raka gušterače . prilikom imenovanja Тарцевы, čimbenike vezane uz dugotrajan opstanak treba uzeti u obzir.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ratiopharm gmbh - paklitaksela - neoplazme dojki - antineoplastična sredstva - pazenir 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. pazenir 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.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

apomedical d.o.o. - paklitaksel - prašak za suspenziju za infuziju - 5 mg/1 ml - 1 ml suspenzije sadrži: 5 mg paklitaksela

Europska Unija - hrvatski - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - mogamulizumab - sezary syndrome; mycosis fungoides - antineoplastična sredstva - poteligeo indiciran za liječenje odraslih bolesnika s kandidijaza usne šupljine (mf) ili sindrom sézary (ss), koji je dobio barem jedan prije sistemske terapije.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

pliva d.o.o.sarajevo - erlotinib - film tableta - 25 mg/1 tableta - 1 film tableta sadrži: 25 mg erlotiniba (u obliku erlotinib hidrohlorida )

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

pliva d.o.o.sarajevo - erlotinib - film tableta - 100 mg/1 tableta - 1film tableta sadrži: 100mg erlotiniba (u obliku erlotinib hidrohlorida)

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

pliva d.o.o.sarajevo - erlotinib - film tableta - 150 mg/1 tableta - 1film tableta sadrži: 150 mg erlotiniba (u obliku erlotinib hidrohlorida)

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - erlotinibum - filmom obložena tableta - 100 mg - urbroj: jedna filmom obložena tableta sadrži 100 mg erlotiniba (u obliku erlotinibklorida)

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - erlotinibum - filmom obložena tableta - 150 mg - urbroj: jedna filmom obložena tableta sadrži 150 mg erlotiniba (u obliku erlotinibklorida)