Epoetin Alfa Hexal Unione Europea - danese - EMA (European Medicines Agency)

epoetin alfa hexal

hexal ag - epoetin alfa - anemia; kidney failure, chronic; cancer - antianemiske præparater - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. behandling af anæmi og til nedsættelse af transfusion hos voksne patienter, der modtager kemoterapi for massive tumorer, malignt lymfom eller myelomatose, og ved risiko for transfusion som vurderet af patientens almene status (e. hjerte-kar-status, præ-eksisterende anæmi ved start af kemoterapi).

Mircera Unione Europea - danese - EMA (European Medicines Agency)

mircera

roche registration gmbh - methoxy polyethylen glycol-epoetin beta - anemia; kidney failure, chronic - antianemiske præparater - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

AviPro THYMOVAC lyofilisat til anvendelse i drikkevand Danimarca - danese - Lægemiddelstyrelsen (Danish Medicines Agency)

avipro thymovac lyofilisat til anvendelse i drikkevand

lohmann animal health gmbh - kyllinge anæmi (ca) virus, stamme cux-1 (svækket) - lyofilisat til anvendelse i drikkevand - fjerkræ

Reblozyl Unione Europea - danese - EMA (European Medicines Agency)

reblozyl

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - andre præparater antianemic - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5. reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.

Imukin 200 mikrogram/ml injektionsvæske, opløsning Danimarca - danese - Lægemiddelstyrelsen (Danish Medicines Agency)

imukin 200 mikrogram/ml injektionsvæske, opløsning

horizon pharma ireland limited - interferon gamma-1b, human biosyntetisk - injektionsvæske, opløsning - 200 mikrogram/ml

Tetraspan 60 mg/ml infusionsvæske, opløsning Danimarca - danese - Lægemiddelstyrelsen (Danish Medicines Agency)

tetraspan 60 mg/ml infusionsvæske, opløsning

b. braun melsungen - Æblesyre, calciumchloriddihydrat, hydroxyethylstivelse, kaliumchlorid, magnesiumchloridhexahydrat, natriumacetattrihydrat, natriumchlorid - infusionsvæske, opløsning - 60 mg/ml

Venofundin 60 mg/ml infusionsvæske Danimarca - danese - Lægemiddelstyrelsen (Danish Medicines Agency)

venofundin 60 mg/ml infusionsvæske

b. braun melsungen - hydroxyethylstivelse, natriumchlorid - infusionsvæske - 60 mg/ml

Revolade Unione Europea - danese - EMA (European Medicines Agency)

revolade

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 og 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 og 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.

Amgevita Unione Europea - danese - EMA (European Medicines Agency)

amgevita

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - immunosuppressiva - rheumatoid arthritis  amgevita in combination with methotrexate, is indicated for: , the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. behandling af alvorlig, aktiv og progressiv reumatoid artritis hos voksne, der ikke tidligere er behandlet med methotrexat. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita reducerer hastigheden af progressionen af ledskader, som målt ved hjælp af x-ray og forbedrer den fysiske funktion, når det gives i kombination med methotrexat. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). amgevita kan gives som monoterapi i tilfælde af intolerance overfor methotrexat eller når fortsatte behandling med methotrexat er upassende (for effekten i monoterapi se afsnit 5. adalimumab er ikke blevet undersøgt hos patienter i alderen mindre end 2 år. enthesitis-related arthritis amgevita is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritis ankylosing spondylitis (as) amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of as amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. psoriatic arthritis amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. amgevita reducerer hastigheden af progressionen af perifere ledskader, som målt ved hjælp af x-ray i patienter med polyartikulær symmetrisk undertyper af sygdommen (se afsnit 5. 1) og forbedrer den fysiske funktion. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs) amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 og 5. crohn’s disease amgevita is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's disease amgevita is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitis amgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitis amgevita is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Rilonacept Regeneron (previously Arcalyst) Unione Europea - danese - EMA (European Medicines Agency)

rilonacept regeneron (previously arcalyst)

regeneron uk limited - rilonacept - cryopyrin-associerede periodiske syndromer - immunosuppressiva - rilonacept regeneron er indiceret til behandling af cryopyrin-associerede periodiske syndromer (caps) med svære symptomer, herunder familiær kolde auto-inflammatoriske syndrom (fcas) og muckle-wells syndrom (mws), hos voksne og børn i alderen 12 år og ældre.