Inrebic Uniunea Europeană - română - EMA (European Medicines Agency)

inrebic

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - agenți antineoplazici - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Innovax-ND-IBD Uniunea Europeană - română - EMA (European Medicines Agency)

innovax-nd-ibd

intervet international b.v. - celule asociate viu recombinant turcia herpesvirus (tulpina hvp360), exprimarea proteinei de fuziune a nd virus și vp2 proteine de ibd virus - aviare, virusul herpes (marek boala lui) + virusul bursitei infecțioase aviare (boala de gumboro) + virusul bolii de newcastle/paramixovirus - chicken; embryonated chicken eggs - for active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (ibd) virus,to reduce mortality, clinical signs and lesions caused by marek’s disease (md) virus.

Breyanzi Uniunea Europeană - română - EMA (European Medicines Agency)

breyanzi

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - agenți antineoplazici - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Kolbam Uniunea Europeană - română - EMA (European Medicines Agency)

kolbam

retrophin europe ltd - acidul cholic - metabolismul, erorile înnăscute - terapia cu bila și cu ficatul - acid colic fgk este indicat pentru tratamentul de erori innascute de primar sinteza acizilor biliari, de la sugari la vârsta de o lună continuă pe tot parcursul vieții tratament prin maturitate, care să cuprindă următoarele singură enzimă defecte:sterol 27-hidroxilaza (prezentarea ca cerebrotendinous xanthomatosis, ctx) deficiență;2- (sau alfa-) methylacyl-coa racemase (amacr) deficiență;colesterol 7-alfa-hidroxilaza (cyp7a1) deficit.

Orphacol Uniunea Europeană - română - EMA (European Medicines Agency)

orphacol

theravia - acidul cholic - digestive system diseases; metabolism, inborn errors - acizii biliari și derivaților - orphacol este indicat pentru tratamentul de înnăscută de erori în sinteza de acid biliar primar din cauza deficientei 3β-hidroxi-Δ5-c27-steroizi oxidoreductase sau Δ4-3-oxosteroid-5β-reductazei deficienta la sugari, copii şi adolescenţi în vârstă de o lună de la 18 ani şi adulti.

Yescarta Uniunea Europeană - română - EMA (European Medicines Agency)

yescarta

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - agenți antineoplazici - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Kinpeygo Uniunea Europeană - română - EMA (European Medicines Agency)

kinpeygo

stada arzneimittel ag - budesonide, micronised - glomerulonephritis, iga - antidiareice, antiinflamatoare intestinale / antiinfective agenți - 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.

Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) Uniunea Europeană - română - EMA (European Medicines Agency)

chenodeoxycholic acid leadiant (previously known as chenodeoxycholic acid sigma-tau)

leadiant gmbh - chenodeoxycholic acid - xanthomatosis, cerebrotendinous; metabolism, inborn errors - terapia cu bila și cu ficatul - acidul chenodeoxycholic este indicat pentru tratamentul de erori înnăscută de sinteza acizilor primare din cauza sterol 27 fenilalaninhidroxilazei deficit (prezentarea ca cerebrotendinous xanthomatosis (ctx)) la sugari, copii şi adolescenţi în vârstă de 1 lună de la 18 ani şi adulti.

Flebogamma DIF (previously Flebogammadif) Uniunea Europeană - română - EMA (European Medicines Agency)

flebogamma dif (previously flebogammadif)

instituto grifols s.a. - imunoglobulina umană normală - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - seruri imune și imunoglobuline, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.