COMPANY CORE SAFETY INFORMATION

It is the reference information by which listed and unlisted are deter-mined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.All relevant safety information contained in the Company Core Data Sheet prepared by the Marketing Authorisation Holder and which the Marketing Authorisation Holder requires to be listed in all countries where the company markets the product, except when the local regulatory authority specifically requires a modification.