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

cyramza

eli lilly nederland b.v. - ramucirumab - neoplazme želuca - antineoplastična sredstva - cancercyramza želuca u kombinaciji s paklitaksel je indiciran za liječenje odraslih bolesnika s rakom želuca ili gastro-пищеводная аденокарцинома veze s napredovanje bolesti nakon prethodnog platine i fluoropyrimidine kemoterapije. cyramza монотерапия indiciran za liječenje odraslih bolesnika s rakom želuca ili gastro-пищеводный razdvajanje аденокарцинома s napredovanje bolesti nakon prethodnog platine ili fluoropyrimidine kemoterapije, za koje je terapija u kombinaciji s паклитакселом ne odgovara. cancercyramza debelog crijeva, u kombinaciji s folfiri (иринотекан, фолиновой kiselina i 5‑fluorouracil), indiciran za liječenje odraslih bolesnika s metastaze колоректальным raka (mcrc) s napredovanje bolesti tijekom ili nakon prethodne terapije бевацизумабом, Оксалиплатин i fluoropyrimidine. non-mali cancercyramza pluća stanice u kombinaciju sa docetaxel indiciran za liječenje odraslih bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća s napredovanje bolesti nakon kemoterapije платиносодержащей. Гепатоцеллюлярная carcinomacyramza монотерапия indiciran za liječenje odraslih bolesnika s preliminarnim ili operirati гепатоцеллюлярной karcinom, koji imaju u serumu, alfa-фетопротеина (АФП) iznosi ≥ 400 ng/ml, a koje su prethodno liječenih Сорафениб.

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

darzalex

janssen-cilag international n.v. - daratumumab - multipli mijelom - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. u kombinaciji s бортезомибом, талидомидом i дексаметазоном za liječenje odraslih bolesnika s prvi put utvrđenom multiplog mijeloma, koji imaju pravo za obavljanje autologna transplantacija matičnih stanica . u kombinaciji s леналидомидом i дексаметазоном i бортезомибом i дексаметазоном za liječenje odraslih bolesnika s multiplog mijeloma, koji je dobio barem jedne prethodne terapije. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. u monoterapiji za liječenje odraslih bolesnika s ponavljajućom i uporan multiplog mijeloma, čija je ranije terapija je uključivala inhibitor протеасом i иммуномодулирующего agent i koji je pokazao napredovanje bolesti na zadnje terapije. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

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

daxas

astrazeneca ab - roflumilast - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - daxas je indiciran za terapiju održavanja teške kronične opstruktivne plućne bolesti (kopb) (fev1 manji od 50% predvidjeti) povezane s kroničnim bronhitisom kod odraslih bolesnika s učestalim egzacerbacijama u anamnezi kao dodatak bronhodilatacijska terapija.

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

esbriet

roche registration gmbh - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - imunosupresivi - esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.

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%.

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

velcade

janssen-cilag international nv - bortezomib - multipli mijelom - antineoplastična sredstva - velcade kao monoterapija ili u kombinaciji s pegiliranim liposomalnim doksorubicinom ili deksametazon je indiciran za liječenje odraslih bolesnika s progresivnim multiplog mijeloma koji su primili najmanje 1 prethodne terapije i koji su prošli ili su neprikladan za hematopoetskih matičnih stanica. Велкейда u kombinaciji s мелфаланом i преднизолоном indiciran za liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma koji se ne mogu tvrditi da su visoke doze kemoterapije s transplantacije matičnih stanica hematopoetske . Велкейд u kombinaciji s дексаметазон, deksametazona i талидомида je za indukcije liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma, koji imaju pravo na высокодозную kemoterapiju s transplantacije matičnih stanica hematopoetske . Велкейд u kombinaciji s rituksimab, ciklofosfamid, doksorubicin i prednizolona indiciran za liječenje odraslih bolesnika s prethodno liječenih liječenje limfoma iz stanica plašt, koji nisu spremni za transplantaciju гемопоэтических matičnih stanica .

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

solymbic

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - imunosupresivi - molimo pogledajte odjeljak 4. 1 sažetak značajki proizvoda u dokumentu o informacijama o proizvodu.

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

torisel

pfizer europe ma eeig - Темсиролимус - carcinoma, renal cell; lymphoma, mantle-cell - antineoplastična sredstva - Почечно-stanični carcinomatorisel indiciran za prva linija terapije kod odraslih pacijenata s česta почечно-клеточным raka (pkr), koji imaju najmanje tri od šest prognostičke faktore rizika . Мантийно-stanica lymphomatorisel indiciran za liječenje odraslih bolesnika s ponavljajućom i / ili vatrostalne мантийно-stanica limfoma (Μl).

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

vectibix

amgen europe b.v. - panitumumab - kolorektalne neoplazme - antineoplastična sredstva - vectibix is indicated for the treatment of adult patients with wild-type ras metastatic colorectal cancer (mcrc): , in first-line in combination with folfox or folfiri. u drugom redu u kombinaciji s folfiri za pacijente koji su primili prve linije fluoropyrimidine temelju kemoterapije (osim иринотекан). u monoterapiji neučinkovitosti fluoropyrimidine-, Оксалиплатин-i иринотекан-sadrže načina kemoterapije .

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

dupixent

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agenti za dermatitis, isključujući kortikosteroide - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.