Medicines for older people: assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal products.

Purpose: To describe whether for the cardiovascular and antithrombotic medicines approved in the period 2006-2016 (a) the pivotal trial was designed with an upper ageexclusion criterion, (b) the age distribution of the participants in the registration trials reflected expected use, (c) post-authorisation studies were planned, and d) the age distribution of participants was clearly presented in the approval documents.

Methods: The data provided to EMA in support of centralized marketing authorisations of were analysed.

Results: Two out of 19 protocols excluded patients over 80 and 85 years old.