Upstaza Den Europæiske Union - ungarsk - 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.

Xromi Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

xromi

nova laboratories ireland limited - hidroxi- - anémia, sarlósejt - daganatellenes szerek - megelőzés, a vaso-elnyelő szövődmények a sarlósejtes betegség, a betegek több mint 2 év.

Luxturna Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

luxturna

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna kezelésére javallt, a felnőtt, gyermek betegek látás elvesztése miatt öröklött retina dystrophia által okozott megerősítette, biallelic rpe65 mutációk, akik elegendő életképes retinális sejtek.

Revolade Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

revolade

novartis europharm limited - eltrombopag - purpura, trombocitopén, idiopátiás - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 és 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 és 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Zepatier Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

zepatier

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitis c, krónikus - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 és 5. a hepatitis c vírus (hcv) genotípus specifikus tevékenység, lásd 4. 4 és 5.

Pirfenidone axunio (previously Pirfenidone AET) Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

pirfenidone axunio (previously pirfenidone aet)

axunio pharma gmbh - pirfenidone - idiopátiás pulmonáris fibrózis - immunszuppresszánsok - pirfenidone aet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Scemblix Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

scemblix

novartis europharm limited - asciminib hydrochloride - leukémia, mielogén, krónikus, bcr-abl pozitív - daganatellenes szerek - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Pirfenidone Viatris Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

pirfenidone viatris

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunszuppresszánsok - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Humira Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

humira

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - immunszuppresszánsok - kérjük, olvassa el a termékinformációs dokumentumot.

Zynlonta Den Europæiske Union - ungarsk - EMA (European Medicines Agency)

zynlonta

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - daganatellenes szerek - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.