Yervoy Europska Unija - hrvatski - EMA (European Medicines Agency)

yervoy

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%.

Tarceva Europska Unija - hrvatski - EMA (European Medicines Agency)

tarceva

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.

Topotecan Actavis Europska Unija - hrvatski - EMA (European Medicines Agency)

topotecan actavis

actavis group ptc ehf - topotekan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastična sredstva - monoterapija topotekan je indicirana za liječenje bolesnika s relapsirajućim karcinomom pluća malih stanica [sclc] za koje ponovno liječenje s režimom prvog reda nije prikladno. 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.

Topotecan Hospira Europska Unija - hrvatski - EMA (European Medicines Agency)

topotecan hospira

pfizer europe ma eeig - topotekan - uterine cervical neoplasms; small cell lung carcinoma - drugi antineoplastični agensi - monoterapija topotekan je indicirana za liječenje bolesnika s recidiviranim karcinomom pluća malih stanica (sclc) za koje ponovno liječenje s režimom prve linije ne smatra prikladnim. 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 zahtijeva dugotrajno liječenje-free interval za osnovu tretmana sa kombinacijom.

Yondelis Europska Unija - hrvatski - EMA (European Medicines Agency)

yondelis

pharma mar s.a. - trabectedin - ovarian neoplasms; sarcoma - antineoplastična sredstva - yondelis je indiciran za liječenje bolesnika s naprednim sarkom mekog tkiva, nakon neuspjeha anatraciklinima, i ili nezgodan za primanje tih agenata su. podaci o učinkovitosti temelje se uglavnom na bolesnika s liposarkom i leiomyosarcomom. Йонделис u kombinaciji s пегилированным липосомальным doksorubicin (fpga) indiciran za liječenje pacijenata s relaps платино osjetljivi raka jajnika .

Axumin Europska Unija - hrvatski - EMA (European Medicines Agency)

axumin

blue earth diagnostics ireland ltd - fluciclovine (18f) - prostatic neoplasms; radionuclide imaging - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. axumin indiciran za pozitronska emisijska tomografija (pet) ct za otkrivanje recidiva raka prostate kod odraslih muškaraca sumnja na recidiv, na temelju povišeni krvni razine specifičnog antigena prostate (psa) nakon primarnog liječenja.

Braftovi Europska Unija - hrvatski - EMA (European Medicines Agency)

braftovi

pierre fabre medicament - encorafenib - melanoma; colorectal neoplasms - antineoplastična sredstva - encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, who have received prior systemic therapy.

Carmustine medac (previously Carmustine Obvius) Europska Unija - hrvatski - EMA (European Medicines Agency)

carmustine medac (previously carmustine obvius)

medac gesellschaft für klinische spezialpräparate mbh - кармустином - hodgkin disease; lymphoma, non-hodgkin - antineoplastična sredstva - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

Phelinun Europska Unija - hrvatski - EMA (European Medicines Agency)

phelinun

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - antineoplastična sredstva - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Jemperli Europska Unija - hrvatski - EMA (European Medicines Agency)

jemperli

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.