Transcription of SCIENTIFIC DISCUSSION 1. Introduction
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1/42 EMEA 2005 SCIENTIFIC DISCUSSION this module reflects the initial SCIENTIFIC DISCUSSION for the approval of Herceptin. this SCIENTIFIC DISCUSSION has been updated until 30 November 2004 . For information on changes after this date please refer to module 8B. 1. Introduction Herceptin contains the active substance trastuzumab (anti-p185, rhuMab HER2), which is a humanised monoclonal antibody that binds to the HER2 protein. HER-2 is a transmembrane spanning receptor-like protein, which is structurally related to the epidermal growth factor receptor and has been shown to inhibit the proliferation of human tumor cells that overexpress HER2 both in vitro and in vivo.
SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Herceptin. This scientific discussion has been updated until 30 November 2004. For information on changes after this date please refer to module 8B. 1. Introduction Herceptin contains the active substance trastuzumab (anti-p185, rhuMab HER2), which is a
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