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SMC ID Date Medicine Submission Type Indication
SMC2298 09/11/2020 trastuzumab emtansine (Kadcyla) Full

As a single agent, for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and / or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
990/14 10/04/2017 trastuzumab emtansine (Kadcyla) Resubmission As a single agent, for the treatment of adult patients with human epidermal growth factor type 2 (HER2)-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for locally advanced or metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant therapy.

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