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

mylan b.v. dieselweg 25 3752 lb bunschoten - ofloxacine 400 mg/stuk - filmomhulde tablet - carnaubawas (e 903) ; hyprolose (e 463) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; lactose 0-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; natriumzetmeelglycolaat ; polyethyleenglycol (e 1521) ; talk (e 553 b) ; titaandioxide (e 171), carnaubawas (e 903) ; hyprolose (e 463) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; lactose 0-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; natriumzetmeelglycolaat (e468) ; polyethyleenglycol (e 1521) ; talk (e 553 b) ; titaandioxide (e 171), - ofloxacin

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

ntc srl via luigi razza 3 20124 milaan (italiË) - ofloxacine - oogdruppels, oplossing - benzalkoniumchloride ; natriumchloride ; natriumhydroxide (e 524) ; water voor injectie ; zoutzuur (e 507) - ofloxacin

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

ntc srl via luigi razza 3 20124 milaan (italiË) - ofloxacine - oogdruppels, oplossing - natriumchloride ; natriumhydroxide (e 524) ; water voor injectie ; zoutzuur (e 507) - ofloxacin

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

novelty. technology. care s.r.l. - ofloxacine 3 mg/ml - oogdruppels, oplossing in verpakking voor éénmalig gebruik - 3 mg/ml - ofloxacine 3 mg/ml - ofloxacin

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

novelty. technology. care s.r.l. - ofloxacine 3 mg/ml - oogdruppels, oplossing - 3 mg/ml - ofloxacine 3 mg/ml - ofloxacin

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

dechra regulatory b.v. - butylhyoscinebromide 4 mg/ml - eq. hyoscine 2,76 mg/ml; metamizolnatriummonohydraat 500 mg/ml - eq. metamizol 443 mg/ml - oplossing voor injectie - 500 mg/ml - 4 mg/ml - metamizolnatriummonohydraat 500 mg/ml; butylhyoscinebromide 4 mg/ml - butylscopolamine and analgesics - paard; hond; varken; rund

Europese Unie - Nederlands - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastro-intestinale stromale tumoren - andere antineoplastische middelen, proteïne kinase remmers - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastro-intestinale stromale tumoren - antineoplastische middelen - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

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

dossier b.v. waardsedijk oost 8 3417 xj montfoort - atropa bella-donna d12 ; rhus toxicodendron d12 ; urtica dioica d12 - druppels voor oraal gebruik, oplossing - , , , , , , , , , , , , , , , , , , , , , , , , , - datum verstrekking handelsvergunning:09 februari 2004