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

rixathon

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - antineoplastiske midler - rixathon is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rixathon is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. rixathon 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. rixathon 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. rixathon 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). kronisk lymfatisk leukæmi (cll)rixathon i kombination med kemoterapi er indiceret til behandling af patienter med tidligere ubehandlet og recidiverende/refraktær kronisk lymfatisk leukæmi. foreligger kun begrænsede oplysninger om effekt og sikkerhed for patienter, der tidligere er behandlet med monoklonale antistoffer, herunder rituximab eller patienter ildfaste materialer til tidligere rituximab plus kemoterapi. se afsnit 5. 1 for yderligere information. reumatoid arthritisrixathon i kombination med methotrexat er indiceret til behandling af voksne patienter med svær aktiv leddegigt, der har haft et utilstrækkeligt respons eller intolerance over for andre sygdomsmodificerende anti-reumatiske lægemidler (dmard), herunder en eller flere tumor nekrose faktor (tnf) - hæmmer behandlinger. rituximab har vist sig at reducere hastigheden af progressionen af ledskader, som målt ved hjælp af x-ray, og til at forbedre den fysiske funktion, når det gives i kombination med methotrexat. granulomatosis with polyangiitis and microscopic polyangiitisrixathon, 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). rixathon, 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 vulgarisrixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

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

riximyo

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antineoplastiske midler - 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. foreligger kun begrænsede oplysninger om effekt og sikkerhed for patienter, der tidligere er behandlet med monoklonale antistoffer, herunder rituximab eller patienter ildfaste materialer til tidligere rituximab plus kemoterapi. se afsnit 5. 1 for yderligere information. 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 har vist sig at reducere hastigheden af progressionen af ledskader, som målt ved hjælp af x-ray, og til at forbedre den fysiske funktion, når det gives i kombination med methotrexat. 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).

Avaxim injektionsvæske, suspension, fyldt injektionssprøjte Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

avaxim injektionsvæske, suspension, fyldt injektionssprøjte

sanofi pasteur europe - hepatitis a virus, stamme gbm (inaktiveret) - injektionsvæske, suspension, fyldt injektionssprøjte

Engerix-B 10 mikrogram/0,5 ml 20 mikrogram/ml injektionsvæske, suspension, fyldt injektionssprøjte Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

engerix-b 10 mikrogram/0,5 ml 20 mikrogram/ml injektionsvæske, suspension, fyldt injektionssprøjte

glaxosmithkline pharma a/s - hepatitis b virus overfladeantigen (rdna) - injektionsvæske, suspension, fyldt injektionssprøjte - 20 mikrogram/ml

Havrix 1440 EU/ml injektionsvæske, suspension Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

havrix 1440 eu/ml injektionsvæske, suspension

glaxosmithkline pharma a/s - hepatitis a virus, stamme hm 175 (inaktiveret) - injektionsvæske, suspension - 1440 eu/ml

Havrix 1440 EU/ml injektionsvæske, suspension Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

havrix 1440 eu/ml injektionsvæske, suspension

orifarm a/s - hepatitis a virus, stamme hm 175 (inaktiveret) - injektionsvæske, suspension - 1440 eu/ml

Varivax 1350 PFU/0,5 ml pulver og solvens til injektionsvæske, suspension Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

varivax 1350 pfu/0,5 ml pulver og solvens til injektionsvæske, suspension

merck sharp & dohme b.v. - varicella virus (vzv), st. oka/merck, levende, svækket - pulver og solvens til injektionsvæske, suspension - 1350 pfu/0,5 ml

Vaqta 50 e./ml injektionsvæske, suspension, fyldt injektionssprøjte Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

vaqta 50 e./ml injektionsvæske, suspension, fyldt injektionssprøjte

merck sharp & dohme b.v. - hepatitis a virus, stamme cr 326f (inaktiveret) - injektionsvæske, suspension, fyldt injektionssprøjte - 50 e./ml

Varilrix 2000 PFU pulver og solvens til injektionsvæske, opløsning, fyldt injektionssprøjte Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

varilrix 2000 pfu pulver og solvens til injektionsvæske, opløsning, fyldt injektionssprøjte

glaxosmithkline pharma a/s - varicella zoster virus, st. oka (levende, svækket) - pulver og solvens til injektionsvæske, opløsning, fyldt injektionssprøjte - 2000 pfu

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

dengvaxia

sanofi pasteur - chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated) - dengue - vacciner - dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4. 2, 4. 4 og 4. brug af dengvaxia bør være i overensstemmelse med de officielle anbefalinger.