Transcription of SCIENTIFIC DISCUSSION 1. Introduction
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SCIENTIFIC DISCUSSION 1. Introduction
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. Herceptin is presented as a white to pale yellow lyophilised powder for concentrate for solution for infusion.
Trastuzumab is formulated as a lyophilised powder and each vial is designed to deliver 150 mg trastuzumab. The finished product also includes 3.36 mg L-Histidine HCl, 2.16 mg L-Histidine, 136.2 mg trehalose, dihydrate, and 0.6 mg polysorbate 20. The sterile solution is filled aseptically into 15 ml Type I borosilicate glass vials with 20 mm
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