Unituxin Európska únia - slovenčina - EMA (European Medicines Agency)

unituxin

united therapeutics europe ltd - dinutuximab - neuroblastómu - antineoplastické činidlá - unituxin je indikovaný ako liečba vysokorizikových neuroblastóm u pacientov vo veku 12 mesiacov až 17 rokov, ktorí predtým dostali indukčná chemoterapia a dosiahnuť aspoň čiastočnú odpoveď, nasleduje myeloablatívnu terapiu a kmeňových buniek transplantáciu (asct). sa podáva v kombinácii s granulocytov makrofágov faktor stimulujúci kolónie (gm-csf), interleukín-2 (il-2) a izotretinoínu..

Symtuza Európska únia - slovenčina - EMA (European Medicines Agency)

symtuza

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infekcie - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza je indikovaný na liečbu vírusu ľudskej imunodeficiencie typu 1 infekcie (hiv‑1) u dospelých a dospievajúcich (vo veku 12 rokov a starších s telesná hmotnosť aspoň 40 kg). genotypic testing should guide the use of symtuza.

Rozlytrek Európska únia - slovenčina - EMA (European Medicines Agency)

rozlytrek

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastické činidlá - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Orladeyo Európska únia - slovenčina - EMA (European Medicines Agency)

orladeyo

biocryst ireland limited - berotralstat dihydrochloride - angioedémy, dedičné - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.