Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

glenmark arzneimittel gmbh industriestrasse 31 82194 grobenzell (duitsland) - ezetimib 10 mg/stuk ; simvastatine 10 mg/stuk - tablet - butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460(i)) ; citroenzuur 1-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat ; propylgallaat (e 310), butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460) ; citroenzuur 1-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat (e 487) ; propylgallaat (e 310) - simvastatin and ezetimibe

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

glenmark arzneimittel gmbh industriestrasse 31 82194 grobenzell (duitsland) - ezetimib 10 mg/stuk ; simvastatine 20 mg/stuk - tablet - butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460(i)) ; citroenzuur 1-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat ; propylgallaat (e 310), butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460) ; citroenzuur 1-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat (e 487) ; propylgallaat (e 310) - simvastatin and ezetimibe

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

glenmark arzneimittel gmbh industriestrasse 31 82194 grobenzell (duitsland) - ezetimib 10 mg/stuk ; simvastatine 40 mg/stuk - tablet - butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460(i)) ; citroenzuur 1-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat ; propylgallaat (e 310), butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460) ; citroenzuur 1-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat (e 487) ; propylgallaat (e 310) - simvastatin and ezetimibe

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

glenmark arzneimittel gmbh industriestrasse 31 82194 grobenzell (duitsland) - ezetimib 10 mg/stuk ; simvastatine 80 mg/stuk - tablet - butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460(i)) ; citroenzuur 1-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat ; propylgallaat (e 310), butylhydroxyanisol (e 320) ; cellulose, microkristallijn (e 460) ; citroenzuur 1-water (e 330) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat (e 487) ; propylgallaat (e 310) - simvastatin and ezetimibe

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ratiopharm gmbh - voriconazol; - filmomhulde tablet - voriconazole

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ratiopharm gmbh - voriconazol; - filmomhulde tablet - voriconazole

Kesatuan Eropah - Belanda - 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.

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

glenmark arzneimittel gmbh industriestrasse 31 82194 grobenzell (duitsland) - abacavirhydrochloride 1-water 714,2 mg/stuk samenstelling overeenkomend met ; abacavir 600 mg/stuk ; lamivudine 0-water 300 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; macrogol 400 ; magnesiumstearaat (e 470b) ; polysorbaat 80 (e 433) ; povidon k 30 (e 1201) ; titaandioxide (e 171) ; zonnegeel fcf aluminiumlak (e 110), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; macrogol 400 ; magnesiumstearaat (e 470b) ; polysorbaat 80 (e 433) ; povidon k 30 (e 1201) ; titaandioxide (e 171) ; zonnegeel fcf aluminiumlak (e 110), - lamivudine and abacavir

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aristo pharma gmbh - simvastatine; - filmomhulde tablet - simvastatin

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aristo pharma gmbh - simvastatine; - filmomhulde tablet - simvastatin