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Marktzulassung widerrufen - Europa

  • Produkt: IMATINIB TEVA B.V.
  • ATC-Code : L01XE01
  • EU-Nummer: EU/1/17/1243
  • MA date : 15/11/2017
  • Zulassungsinhaber: TEVA PHARMACEUTICALS EUROPE B.V.

Therapeutic indication

Imatinib Teva B.V. is indicated for the treatment of:
* 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.
* Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
* Adult patients with Ph+ CML in 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 Teva B.V. is indicated for:
* 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 treatment.
* 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.

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