Imatinib Mesylate 400 mg F.C. Tablets (Imarem®)
【Registration Number】027373
【Active Ingredient】Imatinib 400 mg
【Indication】
Imatinib Mesylate 400 mg F.C. Tablets (Imarem®) is a kinase inhibitor indicated for the treatment of:
  • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
  • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.
  • Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
  • Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
  • Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test.
  • Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown.
  • Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1PDGFRα fusion kinase negative or unknown.
  • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
  • Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
  • Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.
【Manufacturer】Remedica Ltd.
【Manufacturer Address】Aharnon Street, Limassol Industrial Estate, Limassol, 3056, Cyprus.
【Category】Prescription Drug