Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

amgen switzerland ag - filgrastimum - injektionslösung - filgrastimum 30 mio. u., acidum aceticum glaciale, natrii hydroxidi solutio 18% m/m corresp. natrium 31.9 µg, polysorbatum 80, sorbitolum 50 mg, aqua ad iniectabile q.s. ad solutionem pro 1 ml. - neutropenie - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

amgen switzerland ag - filgrastimum adnr - injektionslösung - filgrastimum adnr 48 mio. u., natrii acetas trihydricus, sorbitolum, polysorbatum 80, wasser iniectabilia q.s. zu einer lösung anstelle von 1,6 ml. - neutropenie - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

amgen switzerland ag - filgrastimum - injektionslösung in einer fertigspritze - filgrastimum 30 mio. u., acidum aceticum glaciale, natrii hydroxidi solutio 18% m/m corresp. natrium 15.9 µg, polysorbatum 80, sorbitolum 25 mg, aqua ad iniectabile q.s. ad solutionem pro 0.5 ml. - neutropenie - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

amgen switzerland ag - filgrastimum - injektionslösung in einer fertigspritze - filgrastimum 48 mio. u., acidum aceticum glaciale, natrii hydroxidi solutio 18% m/m corresp. natrium 15.9 µg, polysorbatum 80, sorbitolum 25 mg, aqua ad iniectabile q.s. ad solutionem pro 0.5 ml. - neutropenie - biotechnologika

Belgien - Deutsch - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

amgen europe - filgrastim r-met-hug-csf - injektionslösung - 0.3 mg/ml - filgrastim r-met-hug-csf - filgrastim

Belgien - Deutsch - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

amgen europe - filgrastim r-met-hug-csf - injektionslösung in einer fertigspritze - 48 mio u (0,96 mg/ml) - filgrastim r-met-hug-csf - filgrastim

Belgien - Deutsch - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

amgen europe - filgrastim r-met-hug-csf - injektionslösung in einer fertigspritze - 30 mio u (0,6 mg/ml) - filgrastim r-met-hug-csf - filgrastim

Europäische Union - Deutsch - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hämoglobinurie, paroxysmal - immunsuppressiva - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). klinischer nutzen ist nachgewiesen bei patienten mit hämolyse mit klinischen symptom(s) indikativ von hoher krankheitsaktivität unabhängig von der transfusion geschichte (siehe abschnitt 5.

Europäische Union - Deutsch - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - immunsuppressiva - 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. die behandlung der schweren, aktiven und progressiven rheumatoiden arthritis bei erwachsenen, die zuvor nicht mit methotrexat behandelt. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita reduziert die rate des fortschreitens von gelenkschäden, wie gemessen, durch die x-ray und verbessert die körperliche funktion, wenn sie in kombination mit 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 gegeben werden kann als monotherapie im falle einer unverträglichkeit gegenüber methotrexat oder wenn die fortsetzung der behandlung mit methotrexat ungeeignet ist (für die wirksamkeit in der monotherapie siehe abschnitt 5. adalimumab wurde nicht untersucht bei patienten im alter von weniger als 2 jahren. 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 reduziert die rate der progression der peripheren gelenkschäden, wie gemessen, durch die x-ray bei patienten mit polyarticular symmetrischen subtypen der erkrankung (siehe abschnitt 5. 1) und verbessert die körperliche 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 und 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.

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

amgen switzerland ag - darbepoetinum alfa - injektionslösung in fertigspritze - darbepoetinum alfa 15 µg, natrii phosphates, natrii chloridum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 0.375 ml corresp., darbepoetinum alfa 40 µg/ml. - stimulierung der erythropoese - biotechnologika