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

eu-pharma b.v. de steiger 41 1351 ac almere - eletriptanhydrobromide 48,5 mg/stuk samenstelling overeenkomend met ; eletriptan 40 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; croscarmellose natrium (e 468) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; zonnegeel fcf aluminiumlak (e 110), cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; glyceroltriacetaat (e 1518) ; hypromellose (e 464) ; lactose 1-water ; magnesiumstearaat (e 470b) ; titaandioxide (e 171) ; zonnegeel fcf aluminiumlak (e 110), - eletriptan

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

bode chemie gmbh & co. melanchthonstrasse 27 d-22525 hamburg (duitsland) - isopropylalcohol 450 mg/g ; mecetronium ethylsulfaat 2 mg/g ; propanol 300 mg/g - oplossing voor cutaan gebruik - glycerol 85 per cent (e 422) ; myristylalcohol ; patentblauw v (e 131) ; perfume oil orania ph 799867 (ri) ; water, gezuiverd, glycerol 85 per cent (e 422) ; myristylalcohol ; patentblauw v (e131) ; perfume oil orania ph 799867 (ri) ; water, gezuiverd, - propanol, combinations

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

eu-pharma b.v. de steiger 41 1351 ac almere - tranexaminezuur - filmomhulde tablet - basisch gebutyleerd methacrylaat copolymeer ; cellulose, microkristallijn (e 460) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; macrogol 8000 ; magnesiumstearaat (e 470b) ; povidon (e 1201) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171) ; vanilline, - tranexamic acid

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

eu-pharma b.v. de steiger 41 1351 ac almere - goserelineacetaat samenstelling overeenkomend met ; ; gosereline - implantatietablet - melkzuur(d,l)-glycolzuur copolymeer, - goserelin

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

eu-pharma b.v. de steiger 41 1351 ac almere - diclofenac diethylamine 11,6 mg/g samenstelling overeenkomend met ; diclofenac natrium 10 mg/g - gel - carbomeer 974p ; cocoylcaprylocapraat ; diethylamine ; isopropylalcohol ; macrogolcetostearylether ; paraffine, vloeibaar (e905) ; parfum creme 45 ; propyleenglycol (e 1520) 5 mg/g ; water, gezuiverd - diclofenac

Europese Unie - Nederlands - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. zie hoofdstuk 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Europese Unie - Nederlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 dfsp. 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)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva is geïndiceerd voor de behandeling ofadult en pediatrische patiënten met nieuw gediagnosticeerde philadelphia chromosoom (bcr‑abl) positieve (ph+) chronische myeloïde leukemie (cml) voor wie een beenmergtransplantatie wordt niet beschouwd als de eerste lijn van de behandeling. volwassen en pediatrische patiënten met ph+ cml in de chronische fase na falen van interferon‑alfa therapie, of in de acceleratiefase of ontploffing crisis. volwassen en pediatrische patiënten met nieuw gediagnosticeerde philadelphia chromosoom positieve acute lymfatische leukemie (ph+ all) geïntegreerd met chemotherapie. volwassen patiënten met recidiverende of refractaire ph+ all als monotherapie. volwassen patiënten met myelodysplastische/myeloproliferatieve ziekten (mds/mpd) geassocieerd met platelet-derived growth factor receptor (pdgfr) gen re-arrangementen. volwassen patiënten met geavanceerde hypereosinophilic syndroom (hes) en/of chronische eosinofiele leukemie (cel) met fip1l1-pdgfra herschikking. het effect van imatinib op de uitkomst van beenmergtransplantatie is niet vastgesteld. imatinib teva 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.

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

dr. fisher farma b.v. - adrenaline; - oplossing voor injectie - epinephrine

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

dr. fisher farma b.v. - adrenaline; - oplossing voor injectie - epinephrine