Eiropas Savienība - horvātu - EMA (European Medicines Agency)

novartis europharm limited - ribociklib sukcinata - neoplazme dojki - antineoplastična sredstva - kisqali je indiciran za liječenje žena s hormon receptor (h)‑pozitivan, людское эпидермическое ako uređaj primatelja 2 faktor rasta (her2)‑negativan lokalno-uobičajena ili metastatskih tumora dojke u kombinaciji s inhibitor aromataze, ili fulvestrant kao izvor endokrine terapije na temelju ili u žene koje su primili do hormonske terapije. u pre‑ ili perimenopauzi, endokrini terapija mora biti u kombinaciji s luteinizirajućeg hormona releasing hormon (lhrh) agonist.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektivni imunosupresivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastična sredstva - bevacizumab u kombinaciji s kemoterapijom na bazi fluoropirimidina je indiciran za liječenje odraslih bolesnika s metastatskim karcinomom debelog crijeva ili rektuma. Бевацизумаб u kombinaciji s паклитакселом dizajniran za prvu liniju tretmana odraslih pacijenata s metastaze raka dojke . za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. Бевацизумаб u kombinaciji s капецитабином dizajniran za prvu liniju terapije bolesnika s metastaze raka dojke kod kojih je liječenje s drugim opcijama kemoterapije, uključujući таксаны ili антрациклины, smatra se neprikladnim. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. bevacizumab, 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 other than predominantly squamous cell histology. Бевацизумаб u kombinaciji s эрлотинибом, prikazan je za prva linija terapije kod odraslih pacijenata s нерезектабельными-najčešće metastaze ili recidivom неороговевающий немелкоклеточного raka pluća s epidermalnog faktora rasta (egfr) aktiviraju mutacije. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, 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 iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, 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 vegf inhibitors or vegf receptor-targeted agents. Бевацизумаб u kombinaciji s паклитакселом i цисплатином ili паклитакселом i топотеканом kod pacijenata koji ne mogu dobiti платиновую terapiju, indiciran za liječenje odraslih bolesnika s uporni, relaps ili метастатической карциномой grlića maternice.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

mabxience research sl - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys 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 alymsys in combination with capecitabine. alymsys, 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 other than predominantly squamous cell histology. alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, 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. alymsys, 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 vegf inhibitors or vegf receptor targeted agents. alymsys, in combination with 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. alymsys, 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.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - karcinom, ne-malih stanica pluća - antineoplastična sredstva - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

merck europe b.v.  - cetuksimab - head and neck neoplasms; colorectal neoplasms - antineoplastična sredstva - erbitux indiciran za liječenje bolesnika s receptor epidermalnog faktora rasta (РЭФР)-izraz, rasa divljeg tipa метастатический колоректальный rak:u kombinaciji s иринотеканом temelju kemoterapije;u prvoj liniji u kombinaciji s folfox;kao monoterapija kod bolesnika koji ne Оксалиплатин - i иринотекан-terapija i koji нетерпим na иринотекану. dodatne informacije potražite u odjeljku 5. erbitux indiciran za liječenje bolesnika s плоскоклеточным raka glave i vrata u kombinaciji sa terapijom zračenja pri lokalno-najčešće bolesti;u kombinaciji s kemoterapijom na bazi platine za relaps i/ili метастатической bolesti.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - neoplazme dojki - antineoplastična sredstva - piqray je navedeno u kombinaciji s fulvestrant za liječenje žena nakon menopauze, a muškaraca hormon receptor (op)-pozitivan, людское эпидермическое ako uređaj primatelja 2 faktor rasta (her2 i)-negativan, lokalno-uobičajena ili metastatskih tumora dojke s mutacija pik3ca nakon progresije bolesti nakon hormonske terapije kao monoterapija (vidi odjeljak 5.

Eiropas Savienība - horvātu - 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.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - limfom, mantel-stanica - antineoplastična sredstva - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

rhythm pharmaceuticals netherlands b.v. - setmelanotide - gojaznost - pripravci protiv pretilosti, isključujući. prehrambeni proizvodi - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.