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SMC ID Date Medicine Submission Type Indication
SMC2312 10/05/2021 encorafenib (Braftovi) Full

In combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.
1012/14 12/01/2015 cetuximab (Erbitux) Full Treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
543/09 08/02/2010 cetuximab (Erbitux) Resubmission Metastatic colorectal cancer
543/09 14/04/2009 cetuximab (Erbitux) Full Epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer
547/09 09/03/2009 cetuximab (Erbitux) Non submission Squamous cell cancer of the head and neck
279/06 10/07/2006 cetuximab 2mg/ml intravenous infusion (Erbitux) Full Locally advanced squamous cell cancer of the head and neck
155/05 10/10/2005 cetuximab (Erbitux) IRP In combination with irinotecan for the treatment of patients with epidermal growth factor receptor expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy

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