Kogenate Bayer Európai Unió - magyar - EMA (European Medicines Agency)

kogenate bayer

bayer ag  - octocog alfa - hemofília a - antihaemorrhagiás - a vérzés kezelése és megelőzése az a haemophilia (veleszületett viii faktor hiány) betegeknél. ez a készítmény nem tartalmaz von willebrand-faktort, ezért nem javallott a von willebrand-féle betegség.

Lynparza Európai Unió - magyar - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - petefészekrákos daganatok - daganatellenes szerek - petefészek cancerlynparza az monoterápiában a:fenntartó kezelésére felnőtt betegek speciális (figo stádium iii-iv) brca1/2-mutáns (germline és/vagy szomatikus) magas minőségű epithelialis petefészek, petevezeték cső vagy elsődleges peritoneális rák, akik a válasz (teljes vagy részleges) elvégzését követő első-sorban a platina-alapú kemoterápiához. 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 és 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. a betegek korábban már kezelt antraciklin egy taxane a (neo)adjuváns vagy áttétes beállítás, kivéve, ha a betegek nem voltak alkalmasak ezek a kezelések (lásd 5. betegek hormon receptor (hr)-pozitív emlőrák is előrehaladtak-jén vagy azt követően előzetes endokrin terápia, vagy tekinteni alkalmatlan az endokrin terápia. 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.

Xaluprine (previously Mercaptopurine Nova Laboratories) Európai Unió - magyar - EMA (European Medicines Agency)

xaluprine (previously mercaptopurine nova laboratories)

nova laboratories ireland limited - 6-merkapto-purin-monohidrátot - leukémia, limfóma - daganatellenes szerek - a xaluprine felnőttek, serdülők és gyermekek akut lymphoblastic leukémia (all) kezelésére javallt.

Xtandi Európai Unió - magyar - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamide - prosztatikus daganatok - endokrin terápia - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Upstaza Európai Unió - magyar - EMA (European Medicines Agency)

upstaza

ptc therapeutics international limited - eladocagene exuparvovec - az aminosav metabolizmus, az inborn hibák - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.