Ann: EMA 180 Day Review Questions Received, page-21

Minutes from the Jan Meeting re: Vitrogro

What was the CHMP recommendation and scientific discussion? And what was the BWP report?

(EMEA/H/D/002831) ((substance to be reviewed) insulin-like growth factor-i (igf-i) segment), (hard-to-heal wounds, primarily venous leg ulcers) The Committee discussed the issues identified in this application, mainly regarding the benefit / risk of the product as well as the quality control. Furthermore the members discussed some procedural aspects relating to the CE mark classification. The Committee adopted the CHMP recommendation and scientific discussion together with the List of Questions. The Committee adopted the BWP Report.