Imatinib Mesylate Tablet | Study Design

Imatinib Mesylate Tablets- FDA & EMA – BE Study Design

Regulatory Body FDA/EMA
Study Drug Information Test Product Reference Product
Strength Imatinib 400 mg FDA: Gleevec 400 mg
EMA: Gilvec 400 mg film-coated tabelts
Formulation Tablets tablets
Manufacturer Any Sponsor Novartis
Route Oral Oral
Therapeutic Indication Therapeutic Class: Oncology
Therapeutic Indication: used to treat certain types of cancer (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases)

 

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