Prescribing patterns of tramadol in adults in IMS® primary care databases in France and Germany between 1 January 2006 and 30 June 2016.

Purpose: There is increasing concern with regard to fatal intoxications with prescription opioids and tramadol poisonings. This study aimed to characterise prescribing patterns for tramadol in primary care in France and Germany and identify long-term treatment and potential risk factors for such treatment.

Methods: Adult patients-prescribed tramadol between January 2006 and June 2016 in GP practices in IMS® Disease Analyzer databases in France and Germany were identified.

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.