Sorafenib Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

sorafenib accord

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastična sredstva - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Dimethyl fumarate Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

dimethyl fumarate accord

accord healthcare s.l.u. - dimetil fumarat - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Docetaxel Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

docetaxel accord

accord healthcare s.l.u. - docetaksel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastična sredstva - grudi cancerdocetaxel akord u kombinaciji s doksorubicin i ciklofosfamid je indiciran za adjuvantne terapije pacijenata s:aktivni čvor-pozitivan rak dojke;aktivni čvor-negativnim rakom dojke . za pacijente s операбельным čvor-negativnim rakom dojke, adjuvantne terapije trebalo bi biti ograničeno pravo bolesnika na primanje kemoterapije po međunarodnim kriterijima na primarne terapije ranog raka dojke . akord доцетаксел u kombinaciji s doksorubicin je namijenjen za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke, prethodno liječenih цитотоксической terapija za ovo stanje. Доцетаксел pristanka monoterapija namijenjen je za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti terapije цитотоксической. prethodne kemoterapije moraju uključivati антрациклиновый ili алкилирующий agent. Доцетаксел pristanka u kombinaciji s трастузумабом namijenjen je za liječenje bolesnika s metastatskih tumora dojke, tumora kojima je prisutna gena her2, a koji ranije nisu primali kemoterapiju o popularnog bolesti. akord доцетаксела u kombinaciji s капецитабином namijenjen je za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti цитотоксической kemoterapije. prethodna terapija mora sadržavati антрациклиновый. non-mali-stanice cancerdocetaxel pluća pristanka indiciran za liječenje bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным od raka pluća neučinkovitosti ranije kemoterapije. akord доцетаксела u kombinaciji s цисплатином namijenjen je za liječenje bolesnika s нерезектабельным, lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća kod pacijenata koji nisu prethodno tretirani i kemoterapiju za ove uvjete. prostate cancerdocetaxel accord u kombinaciji s преднизоном ili преднизолоном indiciran za liječenje bolesnika s hormon vatrostalna метастатического raka prostate . Želučani akord adenocarcinomadocetaxel u kombinaciji s цисплатином i 5-фторурацилом namijenjen je za liječenje bolesnika s метастатической аденокарциномой želuca, uključujući i gušterače adenokarcinom пищеводно-želučani tranzicije, koji nisu primili ranije kemoterapije za метастатической bolesti. glava i vrat cancerdocetaxel accord u kombinaciji s цисплатином i 5-фторурацилом za indukcijska terapija bolesnika s lokalno-najčešći плоскоклеточным raka glave i vrata.

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

vegzelma

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma 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. vegzelma 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 anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, 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. vegzelma, 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.

Teriflunomide Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

teriflunomide accord

accord healthcare s.l.u. - teriflunomide - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivima selektivni imunosupresivima - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Dabigatran Etexilate Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

dabigatran etexilate accord

accord healthcare s.l.u. - Дабигатрана этексилат мезилат - venous thromboembolism; arthroplasty, replacement - antitrombotska sredstva - prevention of venous thromboembolic events.

Degarelix Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

degarelix accord

accord healthcare s.l.u. - degarelix acetate - prostatske neoplazme - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Entecavir Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

entecavir accord

accord healthcare s.l.u. - Энтекавир - hepatitis b, kronični - antivirusni lijekovi za sustavnu uporabu - entecavir accord is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. , dekompenziranom bolesti jetre . kao компенсированные i dekompenziranom bolesti jetre, ovaj pokazatelj temelji se na podacima iz kliničkih istraživanja u naivnih pacijenata nukleozida s pozitivnim rezultatom testa na hbeag i hbeag-negativni hbv-infekcije. Što se tiče bolesnika s refluksom hepatitis b lamivudina. Энтекавир accord je također indiciran za liječenje kronične hbv-infekcije u nukleozida naivan pedijatrijska bolesnika od 2 do.

Lenalidomide Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

lenalidomide accord

accord healthcare s.l.u. - lenalidomid - multipli mijelom - imunosupresivi - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) indiciran za liječenje odraslih bolesnika s ranije нелеченной multiplog mijeloma koji se ne oslanja transplantacije. akord леналидомид u kombinaciji s дексаметазоном indiciran za liječenje multiple myeloma kod odraslih pacijenata koji su primili barem jedan tečaj terapija. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Icatibant Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

icatibant accord

accord healthcare s.l.u. - icatibant acetate - angioedemas, nasljedni - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.