Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mukositt - alle andre terapeutiske produkter - kepivance er angitt for å senke forekomsten, varighet og alvorlighetsgrad av muntlig mukositt hos voksne pasienter med hematologisk malignitet mottar myeloablative radiochemotherapy knyttet til en høy forekomst av alvorlig mukositt og krever autologous-haematopoietic-stilk-cellen støtte.

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab - kollagenase clostridium histolyticum - dupuytren contracture - andre legemidler for forstyrrelser i muskel-skjelettsystemet - , the treatment of dupuytren’s contracture in adult patients with a palpable cord. behandling av voksne menn med peyronies sykdom med en håndgripelig plakk og kurvatur misdannelse av minst 30 grader ved start av behandling.

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - trombocytopeni - antihemoragika - doptelet er angitt for behandling av alvorlig trombocytopeni hos voksne pasienter med kronisk leversykdom som er planlagt å gjennomgå en invasiv prosedyre. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosteroider, immunglobuliner).

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab - loncastuximab tesirine - lymphoma, large b-cell, diffuse; lymphoma, b-cell - antineoplastiske midler - zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl), after two or more lines of systemic therapy.

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - eftrenonacog alfa - hemofili b - k-vitamin og andre hemostatics, blodkoagulering faktorer - behandling og profylakse av blødning hos pasienter med hemofili b (medfødt faktor ix-mangel).

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - efmoroctocog alfa - hemofili a - antihemoragika - behandling og profylakse av blødning hos pasienter med hemofili a (medfødt faktor viii-mangel). elocta kan brukes for alle aldersgrupper.

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - immunsuppressive - rheumatoid arthritis (ra)kineret is indicated in adults for the treatment of the signs and symptoms of ra in combination with methotrexate, with an inadequate response to methotrexate alone. covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml. periodic fever syndromeskineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:cryopyrin-associated periodic syndromes (caps)kineret is indicated for the treatment of caps, including:neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca)muckle-wells syndrome (mws)familial cold autoinflammatory syndrome (fcas)familial mediterranean fever (fmf)kineret is indicated for the treatment of familial mediterranean fever (fmf). kineret bør gis i kombinasjon med colchicine, hvis det er aktuelt. still’s diseasekineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of still’s disease, including systemic juvenile idiopathic arthritis (sjia) and adult-onset still’s disease (aosd), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (nsaids) or glucocorticoids. kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (dmards).

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinone - tyrosinemias - andre alimentary tract and metabolism products, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinuri, paroksysmal - immunsuppressive - 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.

Den europeiske union - norsk - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - leddgikt, reumatoid - immunsuppressive - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.