유럽 연합 - 네덜란드어 - EMA (European Medicines Agency)

alnylam netherlands b.v. - lumasiran sodium - hyperoxaluria, primary - andere maagdarmkanaal en metabolisme producten, - treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

유럽 연합 - 네덜란드어 - EMA (European Medicines Agency)

eurogenerics holdings b.v. - teriparatide - osteoporose - calcium homeostase - qutavina is indicated in adults. behandeling van osteoporose bij postmenopauzale vrouwen en bij mannen met een verhoogd risico op fracturen. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. de behandeling van osteoporose in verband met de aanhoudende systemische glucocorticoïden therapie bij vrouwen en mannen met een verhoogd risico op fracturen.

벨기에 - 네덜란드어 - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

b. braun melsungen ag - dexmedetomidinehydrochloride 118 µg/ml - eq. dexmedetomidine 100 µg/ml - concentraat voor oplossing voor infusie - 100 µg/ml - dexmedetomidinehydrochloride 118 µg/ml - dexmedetomidine

벨기에 - 네덜란드어 - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

b. braun melsungen ag - dexmedetomidinehydrochloride 118 µg/ml - eq. dexmedetomidine 100 µg/ml - concentraat voor oplossing voor infusie - 100 µg/ml - dexmedetomidinehydrochloride 118 µg/ml - dexmedetomidine

벨기에 - 네덜란드어 - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

b. braun melsungen ag - dexmedetomidinehydrochloride 118 µg/ml - eq. dexmedetomidine 100 µg/ml - concentraat voor oplossing voor infusie - 100 µg/ml - dexmedetomidinehydrochloride 118 µg/ml - dexmedetomidine

유럽 연합 - 네덜란드어 - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastische middelen - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

유럽 연합 - 네덜란드어 - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastische middelen - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patiënten met een laag of zeer laag risico op herhaling, moet niet ontvangen adjuvante behandeling. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. behalve in nieuw gediagnosticeerde cml in de chronische fase, er zijn geen gecontroleerde studies tonen een klinisch voordeel of een toegenomen overleving voor deze ziekten.

네덜란드 - 네덜란드어 - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ceva sante animale b.v. - paromomycinesulfaat - vloeistof voor oraal gebruik - paromomycinesulfaat 140 mg/ml, - paromomycin - kalveren; varkens

유럽 연합 - 네덜란드어 - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemie, myelogeen, chronisch, bcr-abl positief - antineoplastische middelen - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

유럽 연합 - 네덜란드어 - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selectieve immunosuppressiva - colitis colitisentyvio is geïndiceerd voor de behandeling van volwassen patiënten met matig tot ernstig actieve colitis ulcerosa die een inadequate respons hadden, verloren reactie of intolerant waren voor zowel conventionele therapie of een tumor necrose factor-alfa (tnfa) antagonist. de ziekte van crohn diseaseentyvio is geïndiceerd voor de behandeling van volwassen patiënten met matig tot ernstig actieve ziekte van crohn die een inadequate respons hadden, verloren reactie of intolerant waren voor zowel conventionele therapie of een tumor necrose factor-alfa (tnfa) antagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.