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

faslodex

astrazeneca ab - fulvestrant od - neoplazme dojki - endokrini terapija, anti-estrogeni - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. u pre - ili perimenopauzi, u sveobuhvatnoj liječenju s palbociclib treba kombinirati s luteinizirajućeg hormona releasing hormon (lhrh) agonist.

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

forxiga

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. osim drugih lijekova za liječenje šećerne bolesti tipa 2 . for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Iressa Europska Unija - hrvatski - 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 Europska Unija - hrvatski - 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.

Lynparza Europska Unija - hrvatski - 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.

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

tagrisso

astrazeneca ab - osimertinib mesilate - karcinom, ne-malih stanica pluća - drugi antitumorski lijekovi, inhibitori протеинкиназы - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

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

xigduo

astrazeneca ab - метформина hidroklorid, monohidrat dapagliflozin пропандиол - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo prikazan kod odraslih za liječenje dijabetesa tipa 2 kao dodatak prehrani i vježbe:• kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой dozi samo метформина • u kombinaciji s drugim lijekovima za liječenje šećerne bolesti kod pacijenata, nedovoljno kontroliranim metforminom i ovi lijekovi• kod pacijenata koji su već лечившихся kombinacijom dapagliflozin i метформина kao zasebne tableta. prema rezultatima istraživanja u odnosu na kombinovanu terapiju, utjecaj na glikemijski kontrolu i kardiovaskularnih događaja, a u ispitivanih skupina, vidi 4. 4, 4. 5 i 5.

Onglyza Europska Unija - hrvatski - 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.

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

fasenra

astrazeneca ab - benralizumab - astma - lijekovi za opstruktivne plućne bolesti dišnih putova, - fasenra navodi kao dodatne terapije kod odraslih pacijenata s teškim eozinofilni astmom, adekvatno kontrolirati, bez obzira na visoke doze udahnuti glukokortikoidi plus dugog djelovanja β-адреномиметиков.

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

lokelma

astrazeneca ab - циркониевые cyclosilicate korisnih natrija - hiperkalijemija - svi ostali terapeutski proizvodi - lokelma indiciran za liječenje гиперкалиемию kod odraslih pacijenata.