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.
A separate solvent is no longer part of the drug product. The manufacturing sites of Vacaville (active substance) and of Hoffman La-Roche Basel (finished ... process controls have been established and analysis of three full-scale finished product batches shows ... and residual Protein A at various intermediate stages in the process All results ...
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