CRED Managing Variations Effectively

Chapter C – 1 st example cont.

Proposal: Revision of SmPC section 4.5 ‘Interaction with other medicinal products and other forms of interaction’, based on the results of a clinical study that has revealed a clinically relevant drug-to-drug interaction between eslicarbazepine acetate and rosuvastatin

 C.I.4 (type II)

71 Introduction to Classification of CMC (Quality) / Clinical / PhV Variations