Abstract
In 1987/1988, Cilag submitted EPREX® for approval using the concertation procedure. What follows is an overview of the concertation procedure in theory and then a discussion of the practical experience using the procedure for EPREX®. The paper highlights the importance of the rapporteur, summary of product characteristics, questions, variations, and conclusions with an evaluation of the positive and negative aspects of the procedure as experienced by Cilag.
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