Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

akcea therapeutics ireland limited - volanesorsen sodíka - hyperlipoproteinémia typu i - iných lipidov úprava agentov - waylivra je uvedené ako doplnok k strave dospelých pacientov s geneticky potvrdené, rodinné chylomicronemia syndróm (fcs) a na vysoké riziko pankreatitídy, v ktorých odpoveď na stravu a triglyceridov zníženie terapia bola neprimeraná.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

biomarin international limited - pegvaliase - phenylketonurias - ostatné produkty tráviaceho traktu a metabolizmu - palynziq je indikovaný na liečbu pacientov s fenylketonúria (pku) vo veku 16 rokov a starších, ktorí majú nedostatočné krvi fenylalanínu kontroly (krvné hladiny fenylalanínu väčšou ako 600 micromol/l), napriek tomu, pred manažmentu dostupné možnosti liečby.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - leukémia, myeloidná, akútna - antineoplastické činidlá - xospata je označené ako monotherapy na liečbu dospelých pacientov, ktorí majú relapsed alebo žiaruvzdorné akútna myeloidná leukémia (aml) s flt3 mutácie.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

scipharm sàrl - treprostinil sodíka - hypertenzia, pľúca - antitrombotické činidlá - 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.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

recordati rare diseases - osilodrostat fosfát - cushingov syndróm - kortikosteroidy na systémové použitie - isturisa je indikovaný na liečbu endogénnych cushing syndróm u dospelých.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

novartis europharm limited  - onasemnogene abeparvovec - svalová atrofia, spinálna - iné lieky na poruchy muskuloskeletálneho systému - zolgensma je indikovaný na liečbu:pacienti s 5q chrbtice svalová atrofia (sma) s bi-allelic mutácia v smn1 génu, a klinická diagnóza sma typ 1, orpatients s 5q sma s bi-allelic mutácia v smn1 génu, a až 3 kópie smn2 génu.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

pfizer europe ma eeig - glasdegib maleate - leukémia, myeloidná, akútna - antineoplastické činidlá - daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (aml) in adult patients who are not candidates for standard induction chemotherapy.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

sanofi winthrop industrie - isatuximab - viacnásobný myelóm - antineoplastické činidlá - sarclisa is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi) and have demonstrated disease progression on the last therapy. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystická fibróza - ostatné produkty dýchacej sústavy - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Kesatuan Eropah - Slovak - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - viacnásobný myelóm - antineoplastické činidlá - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.