Iressa Uni Eropa - Kroasia - EMA (European Medicines Agency)

iressa

astrazeneca ab - gefitinib - karcinom, ne-malih stanica pluća - antineoplastična sredstva - Иресса indiciran za liječenje odraslih bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća s aktivacijom mutacija epidermalnog faktora rasta-рецепторных тирозинкиназ.

Komboglyze Uni Eropa - Kroasia - EMA (European Medicines Agency)

komboglyze

astrazeneca ab  - метформина hidroklorid, hidroklorid саксаглиптин - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze je indiciran kao dodatak dijeti i tjelovježbi za poboljšanje kontrole glikemije u odraslih bolesnika u dobi od 18 godina i stariji tip-2 šećerne bolesti glikemija podnošljivom dozom samog ili onih već liječeni kombinacijom saksagliptina i metformina kao zasebnih tableta. komboglyze je također indiciran u kombinaciji s inzulina (ja. trostruka kombinirana terapija) kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod odraslih pacijenata u dobi od 18 godina i stariji tip-2 dijabetesa, kada inzulina i метформина sami ne pružaju adekvatnu glikemijski kontrole.

Lifmior Uni Eropa - Kroasia - EMA (European Medicines Agency)

lifmior

pfizer europe ma eeig - etanercept - arthritis, psoriatic; spondylitis, ankylosing; psoriasis - imunosupresivi - reumatoidni artritis;juvenilni idiopatski artritis arthritispsoriatic;аксиальный спондилоартрит;Бляшковидный psorijaza;dječju бляшковидный psorijaza.

Lynparza Uni Eropa - Kroasia - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - neoplazme jajnika - antineoplastična sredstva - jajnika cancerlynparza prikazan kao monoterapija za:podržava liječenje odraslih bolesnika s поздними (figo faze iii i iv) u genima brca1/2-mutirani (зародышевой linije i/ili somatskih) brzorezni epitela jajnika, masterbatch cijevi ili primarni перитонеальный rak, koji u odgovor (potpuno ili djelomično) nakon završetka prve linije na bazi platine kemoterapije. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 i 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacijenti moraju prethodno bile tretirane s антрациклина i таксана u (neo)adjuvantne ili метастатический, ako pacijenti nisu prikladni za tih postupaka (vidi odjeljak 5. pacijenti s receptore hormona (h)-pozitivnog raka dojke treba također razvili ili nakon pre-hormonska terapija, ili se smatraju neprikladnim za endokrine terapije. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Numient Uni Eropa - Kroasia - EMA (European Medicines Agency)

numient

amneal pharma europe ltd - l-dopa, карбидопа - parkinsonova bolest - antiparkinsonski lijekovi - simptomatsko liječenje bolesnika s parkinsonovom bolešću.

Replagal Uni Eropa - Kroasia - EMA (European Medicines Agency)

replagal

takeda pharmaceuticals international ag ireland branch - agalsidaza alfa - fabry-ovu bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - replagal je indiciran za dugotrajnu terapiju zamjene enzima u bolesnika s potvrđenom dijagnozom fabryove bolesti (nedostatak α-galaktozidaze-a).

Vpriv Uni Eropa - Kroasia - EMA (European Medicines Agency)

vpriv

takeda pharmaceuticals international ag ireland branch - velagluceraza alfa - gaucherova bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - vpriv je indiciran za dugoročnu zamjensku enzimsku terapiju (ert) u bolesnika s tipom 1 gaucherove bolesti.

Revestive Uni Eropa - Kroasia - EMA (European Medicines Agency)

revestive

takeda pharmaceuticals international ag ireland branch - teduglutide - sindromi malapsorpcije - drugi gastrointestinalni trakt i metabolizam, lijekovi, - revestive je indiciran za liječenje bolesnika starijih od jedne godine i više s sindromom kratkog crijeva (sbs). pacijenti bi trebali biti stabilni nakon perioda crijevne adaptacije nakon operacije. revestive indiciran za liječenje bolesnika u dobi od 1 godine i više sa sindromom kratkog crijeva . pacijenti bi trebali biti stabilni nakon perioda crijevne adaptacije nakon operacije.

Plenadren Uni Eropa - Kroasia - EMA (European Medicines Agency)

plenadren

takeda pharmaceuticals international ag ireland branch - hidrokortizon - nedostatak nadbubrežne žlijezde - kortikosteroidi za sistemsku upotrebu - liječenje adrenalne insuficijencije kod odraslih.

Onglyza Uni Eropa - Kroasia - EMA (European Medicines Agency)

onglyza

astrazeneca ab - Саксаглиптин - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.