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Ema Qas Cep Maa Mav 2024

NEWS | QWP Questions and Answers: how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)

This document aims to clarify existing guidance as a compilation of required data to be submitted in a MAA or in certain MAVs when a CEP is referred to in the MA dossier. It is also applicable when an excipient covered by a CEP is used as an active substance (AS). Even if several aspects of this document would equally apply to ASMFs and when full information on active substance is provided in the MA dossier, the focus of this Q&A is on CEPs.

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Cardioregenix Meeting March 2024

CardioReGenix project | March 2024 Progress meeting

The EU-funded CardioReGenix project focuses on technological innovations for the treatment of heart failure and myocardial ischemia. The goal is to overcome obstacles in cardiovascular disease (CVD) gene therapy, capitalising on robust preliminary data and multi-disciplinary consortium know-how in vector development, preclinical and clinical cardiology, business development and clinical translation.

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