Euroopan unioni - ruotsi - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - trombocytopeni - hemostatika - doptelet är indicerat för behandling av svår trombocytopeni hos vuxna patienter med kronisk leversjukdom som är planerade att genomgå ett ingrepp. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosteroider, immunoglobuliner).

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, trombocytopenisk, idiopatisk - 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 och 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 och 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.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. (miol) - febuxostat - gikt - antigout preparat - 80 mg styrka:behandling av kronisk hyperurikemi i förhållanden där urat nedfall har redan skett (inklusive en historia, eller förekomst av, tophus och/eller gouty artrit). adenuric är indicerat hos vuxna. 120 mg styrka:adenuric är indicerat för behandling av kronisk hyperurikemi i förhållanden där urat nedfall har redan skett (inklusive en historia, eller förekomst av, tophus och/eller gouty artrit). adenuric är indicerat för prevention och behandling av hyperurikemi hos vuxna patienter som genomgår kemoterapi för haematologic maligniteter på medel till hög risk för tumör lys syndrom (tls). adenuric är indicerat hos vuxna.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

grünenthal gmbh - lesinurad - hyperurikemi - antigout preparat - zurampic, är i kombination med en xantin oxidas hämmare, indicerat till vuxna för adjuvant behandling av hyperurikemi i gikt patienter (med eller utan tophi) som inte har uppnått målet serum urinsyranivåer med en lämplig dos av ett xantin-oxidas hämmare ensam.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunsuppressiva - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekursorcell lymfoblastisk leukemi-lymfom - antineoplastiska medel - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - multipelt myelom - antineoplastiska medel - tecvayli is indicated as monotherapy 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.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - gikt - antigout preparat - krystexxa är indicerat för behandling av svår försvagande kronisk tofös gikt hos vuxna patienter som också har erosiv gemensamma engagemang och som har misslyckats med att normalisera urinsyranivån i serum med xantin-hämmare vid maximal medicinskt lämplig dos eller för vilka dessa läkemedel är kontraindicerade.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multipelt myelom - antineoplastiska medel - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

stada arzneimittel ag - budesonide, micronised - glomerulonephritis, iga - antidiarrheals, tarm -, antiinflammatoriska / antiinfective agenter - 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.