Europeiska unionen - portugisiska - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - imune soros e imunoglobulinas, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anemia, célula falciforme - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

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

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - outros medicamentos do sistema nervoso - 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.

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

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

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - atrofia muscular, espinhal - outras drogas para distúrbios do sistema músculo-esquelético - 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.

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - agentes antineoplásicos - 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.

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

novo nordisk a/s - somapacitan - crescimento - hormonas e análises pituitárias e hipotalâmicas - 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).

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

diurnal europe b.v. - hidrocortisona - adrenal hyperplasia, congenital - corticosteróides para uso sistêmico - treatment of congenital adrenal hyperplasia (cah) in adolescents aged 12 years and over and adults.

Europeiska unionen - portugisiska - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - imunossupressores - 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.