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

advate

takeda manufacturing austria ag - octocog alfa - hemofília a - antihaemorrhagiás - a vérzés kezelése és megelőzése az a haemophilia (veleszületett viii faktor hiány) betegeknél. az advate-et nem tartalmaz von willebrand-faktort, a farmakológiailag hatásos mennyiségben, ezért nem javallott a von willebrand-betegség.

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

trepulmix

scipharm sàrl - treprostinil nátrium - magas vérnyomás, pulmonalis - antitrombotikus szerek - treatment of adult patients with who functional class (fc) iii or iv and:inoperable chronic thromboembolic pulmonary hypertension (cteph), orpersistent or recurrent cteph after surgical treatmentto improve exercise capacity.

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

zercepac

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - daganatellenes szerek - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. előzetes kemoterápia kell bele legalább egy antraciklin egy taxane, kivéve, ha a betegek nem kezelhetők ezek a kezelések. hormon receptor-pozitív betegek is kudarcot vallott, hormonális kezelés, kivéve, ha a betegek nem kezelhetők ezek a kezelések.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. kombinálva a docetaxel kezelés azoknál a betegeknél, akik nem kaptak kemoterápiát, a metasztatikus betegség. kombinálva egy aromatáz gátló kezelés a posztmenopauzában lévő betegek hormon-receptor pozitív mbc, korábban nem kezelt trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). következő műtét, kemoterápia (neoadjuváns vagy adjuváns), illetve sugárkezelés (ha alkalmazható). következő adjuváns kemoterápia a doxorubicin, ciklofoszfamid, kombinálva a paklitaxel vagy a docetaxel. kombinálva adjuváns kemoterápia álló docetaxel, karboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. pontos, hitelesített vizsgálat módszereket kell alkalmazni.

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

ayvakyt

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinal stromal tumorok - egyéb daganatellenes szerek, a protein kináz inhibitorok - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

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

zynrelef

heron therapeutics, b.v. - bupivacaine, meloxicam - fájdalom, postoperatív - aneszteziológia - zynrelef is indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults (see section 5.

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

jemperli

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

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

kerendia

bayer ag - finerenone - renal insufficiency, chronic; diabetes mellitus, type 2 - a renin-angiotenzin rendszerre ható szerek - kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

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

pylclari

curium pet france - piflufolastat (18f) - prosztatikus daganatok - diagnosztikai radiofarmakonok - ez a gyógyszer csak diagnosztikai célra használható. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).