Европска Унија - Словачки - EMA (European Medicines Agency)

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.

Европска Унија - Словачки - EMA (European Medicines Agency)

advicenne s.a. - potassium citrate monohydrated, potassium hydrogen carbonate - acidosis, renal tubular - mineral supplements - sibnayal is indicated for the treatment of distal renal tubular acidosis (drta) in adults, adolescents and children aged one year and older.

Европска Унија - Словачки - EMA (European Medicines Agency)

serb sas - glucarpidase - metabolic side effects of drugs and substances - všetky ostatné terapeutické produkty - voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.

Европска Унија - Словачки - EMA (European Medicines Agency)

amivas ireland ltd - artesunate - malárie - antiprotozoalů - artesunate amivas is indicated for the initial treatment of severe malaria in adults and children. je treba vziať do úvahy oficiálne usmernenie o vhodnom používaní antimalarial agentov.

Европска Унија - Словачки - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinúria, paroxysmálna - imunosupresíva - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.

Европска Унија - Словачки - EMA (European Medicines Agency)

stada arzneimittel ag - budesonide, micronised - glomerulonephritis, iga - antidiarrheals, črevné protizápalové / antiinfective agentov - kinpeygo is indicated for the treatment of primary immunoglobulin a (iga) nephropathy (igan) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (upcr) ≥1. 5 g/gram.

Европска Унија - Словачки - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - viacnásobný myelóm - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Европска Унија - Словачки - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - aminokyselinový metabolizmus, vrodené chyby - 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.

Европска Унија - Словачки - EMA (European Medicines Agency)

biomarin international limited - valoctocogene roxaparvovec - antihemoragiká - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Европска Унија - Словачки - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - viacnásobný myelóm - antineoplastické činidlá - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.