Polivy Den Europæiske Union - dansk - EMA (European Medicines Agency)

polivy

roche registration gmbh - polatuzumab vedotin - lymfom, b-celle - antineoplastiske midler - polivy i kombination med bendamustine og rituximab er indiceret til behandling af voksne patienter med recidiverende/refraktær diffuse store b-celle lymfom (dlbcl), der ikke er kandidater til hæmatopoietisk stamcelletransplantation. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Blenrep Den Europæiske Union - dansk - EMA (European Medicines Agency)

blenrep

glaxosmithkline (ireland) limited - belantamab mafodotin - multipelt myelom - antineoplastiske midler - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Tepkinly Den Europæiske Union - dansk - EMA (European Medicines Agency)

tepkinly

abbvie deutschland gmbh & co. kg - epcoritamab - lymphoma, large b-cell, diffuse - antineoplastiske midler - tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) after two or more lines of systemic therapy.

Mylotarg Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylotarg

pfizer europe ma eeig - gemtuzumab ozogamicin - leukæmi, myeloid, akut - antineoplastiske midler - mylotarg er angivet for kombinationsbehandling med daunorubicin (dnr) og cytarabine (arac) til behandling af patienter, alder 15 år og derover med tidligere ubehandlet, de novo cd33-positive akut myeloid leukæmi (aml), bortset fra akut promyelocyt leukæmi (apl).

Skyrizi Den Europæiske Union - dansk - EMA (European Medicines Agency)

skyrizi

abbvie deutschland gmbh & co. kg - risankizumab - psoriasis; arthritis, psoriatic - immunosuppressiva - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). crohn's diseaseskyrizi is indicated for the treatment of adult patients with moderately to severely active crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Apexxnar Den Europæiske Union - dansk - EMA (European Medicines Agency)

apexxnar

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 8, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 10a, pneumococcal polysaccharide serotype 11a, pneumococcal polysaccharide serotype 12f, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 15b, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 22f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 33f - pneumokokinfektioner - vacciner - active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. se afsnit 4. 4 og 5. 1 for information om beskyttelse mod specifikke pneumokokserotyper. apexxnar should be used in accordance with official recommendations. .

Idefirix Den Europæiske Union - dansk - EMA (European Medicines Agency)

idefirix

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosuppressiva - 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.

Uplizna Den Europæiske Union - dansk - EMA (European Medicines Agency)

uplizna

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - immunosuppressiva - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Xolair Den Europæiske Union - dansk - EMA (European Medicines Agency)

xolair

novartis europharm limited - omalizumab - asthma; urticaria - medicin for obstruktiv sygdomme, - allergiske asthmaxolair er indiceret hos voksne, unge og børn (6 til.

Rituzena (previously Tuxella) Den Europæiske Union - dansk - EMA (European Medicines Agency)

rituzena (previously tuxella)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastiske midler - rituzena er angivet i voksne til følgende indikationer:non-hodgkin ' s lymfom (nhl)rituzena er indiceret til behandling af tidligere ubehandlede patienter med stadium iii-iv, follikulært lymfom i kombination med kemoterapi. rituzena monoterapi er indiceret til behandling af patienter med stadie iii-iv follikulært lymfom, der er kemo resistente eller er i deres andet eller efterfølgende tilbagefald efter kemoterapi. rituzena er indiceret til behandling af patienter med cd20-positive diffuse store b-celle non hodgkin ' s lymfom i kombination med chop (cyclofosfamid, doxorubicin, vincristin, prednisolon) kemoterapi. kronisk lymfatisk leukæmi (cll)rituzena i kombination med kemoterapi er indiceret til behandling af patienter med tidligere ubehandlet og recidiverende/refraktær cll. foreligger kun begrænsede oplysninger om effekt og sikkerhed for patienter, der tidligere er behandlet med monoklonale antistoffer, herunder rituzenaor patienter ildfaste materialer til tidligere rituzena plus kemoterapi. granulomatosis med polyangiitis og mikroskopiske polyangiitisrituzena, i kombination med glukokortikoider er indiceret til induktion af remission hos voksne patienter med svær, aktive granulomatosis med polyangiitis (wegeners) (gpa) og mikroskopisk polyangiitis (mpa).