Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

stemline therapeutics b.v. - tagraxofusp - lymphoma - antineoplastická činidla - elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (bpdcn).

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - další léky na nervový systém - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - pexidartinib - giant cell tumor of tendon sheath; synovitis, pigmented villonodular - antineoplastická činidla - treatment of tenosynovial giant cell tumour.

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedémy, dědičné - 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.

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - svalová atrofie, spinální - jiné léky na poruchy muskuloskeletálního systému - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - antineoplastická činidla - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

novo nordisk a/s - somapacitan - růst - hypofýzy a hypotalamické hormony a analogy - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

diurnal europe b.v. - hydrokortison - adrenal hyperplasia, congenital - kortikosteroidy pro systémové použití - treatment of congenital adrenal hyperplasia (cah) in adolescents aged 12 years and over and adults.

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - imunosupresiva - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Den Europæiske Union - tjekkisk - EMA (European Medicines Agency)

biomarin international limited - vosoritide - achondroplasia - léky na léčbu nemocí kostí - voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. the diagnosis of achondroplasia should be confirmed by appropriate genetic testing.