Europese Unie - Nederlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioedemas, erfelijk - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

Europese Unie - Nederlands - EMA (European Medicines Agency)

takeda pharmaceuticals international ag - icatibant - angioedemas, erfelijk - hart therapie - firazyr is geïndiceerd voor de symptomatische behandeling van acute aanvallen van erfelijk angio-oedeem (hae) bij volwassenen (met c1-esterase-remmerdeficiëntie).

Europese Unie - Nederlands - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedemas, erfelijk - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Europese Unie - Nederlands - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, erfelijk - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

icatibantacetaat samenstelling overeenkomend met ; ; icatibant 10 mg/ml - oplossing voor injectie - azijnzuur (e 260), geconcentreerd ; natriumchloride ; natriumhydroxide (e 524) ; water voor injectie

Europese Unie - Nederlands - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antineoplastische middelen - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. slechts beperkte gegevens beschikbaar zijn over de werkzaamheid en de veiligheid voor patiënten die eerder werden behandeld met monoklonale antilichamen met inbegrip van rituximab of patiënten vuurvaste vorige rituximab plus chemotherapie. zie sectie 5. 1 voor meer informatie. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituximab is aangetoond dat het verminderen van de snelheid van progressie van gewrichtsschade, zoals gemeten door de x-ray en verbetering van fysiek functioneren, indien gegeven in combinatie met methotrexaat. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Europese Unie - Nederlands - EMA (European Medicines Agency)

actavis group ptc ehf - reteplase - myocardinfarct - antitrombotische middelen - rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (ami) symptoms.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

genzyme europe b.v. paasheuvelweg 25 1105 bp amsterdam - danazol 100 mg/stuk - capsule, hard - ammonia (e 527) ; gelatine (e 441) ; ijzeroxide zwart (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; propyleenglycol (e 1520) ; schellak glaze, gedeeltelijk veresterd ; talk (e 553 b) ; titaandioxide (e 171) ; zwarte inkt, - danazol

Europese Unie - Nederlands - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinurie, paroxysmale - immunosuppressiva - 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.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

mylan b.v. dieselweg 25 3752 lb bunschoten - candesartancilexetil 16 mg/stuk - tablet - carmellose calcium (e 466) ; hyprolose (e 463) ; lactose 1-water ; magnesiumstearaat (e 470b) ; mannitol (d-) (e 421), - candesartan