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

eg sa-nv - imatinibmesilaat 478 mg - eq. imatinib 400 mg - capsule, hard - 400 mg - imatinibmesilaat 478 mg - imatinib

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

fresenius kabi deutschland gmbh - imatinibmesilaat 478 mg - eq. imatinib 400 mg - filmomhulde tablet - 400 mg - imatinibmesilaat 478 mg - imatinib

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

koanaa healthcare ltd. - imatinibmesilaat - eq. imatinib 400 mg - filmomhulde tablet - 400 mg - imatinibmesilaat - imatinib

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

eg sa-nv - imatinibmesilaat 477,88 mg - eq. imatinib 400 mg - filmomhulde tablet - 400 mg - imatinibmesilaat 477.88 mg - imatinib

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

krka d.d. novo mesto d.d. - imatinibmesilaat 478 mg - eq. imatinib 400 mg - filmomhulde tablet - 400 mg - imatinibmesilaat 478 mg - imatinib

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

krka d.d. novo mesto d.d. - imatinibmesilaat 477,87 mg - eq. imatinib 400 mg - dispergeerbare tablet - 400 mg - imatinibmesilaat 477.87 mg - imatinib

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

sandoz sa-nv - imatinibmesilaat 478 mg - eq. imatinib 400 mg - filmomhulde tablet - 400 mg - imatinibmesilaat 478 mg - imatinib

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

aurobindo sa-nv - imatinibmesilaat 477,88 mg - eq. imatinib 400 mg - filmomhulde tablet - 400 mg - imatinibmesilaat 477.88 mg - imatinib

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. .

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

fresenius kabi deutschland gmbh else-kroener strasse 1 61352 bad homburg v.d.h. (duitsland) - imatinibmesilaat 478 mg/stuk samenstelling overeenkomend met ; imatinib 400 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; macrogol 400 ; magnesiumstearaat (e 470b) ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; talk (e 553 b), - imatinib