EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection.

The analysis of safety data from spontaneous reporting systems has a proven value for the detection and analysis of the risks of medicines following their placement on the market and use in medical practice. EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy.

Enhanced Paediatric Pharmacovigilance at the European Medicines Agency: A Novel Query Applied to Adverse Drug Reaction Reports.

Background: Databases of suspected adverse drug reactions (ADRs) are a cornerstone of pharmacovigilance. With increasing numbers of reports, additional statistical approaches are needed to better use the data.

Aim: The present study was aimed at elucidating the European Medicines Agency's (EMA) use of a novel 'paediatric' query to analyse the data in its ADR database 'EudraVigilance'.

Comparison between paediatric and adult suspected adverse drug reactions reported to the European medicines agency: implications for pharmacovigilance.

Background: Databases systematically collecting reports of suspected adverse drug reactions (ADRs) are a cornerstone of pharmacovigilance in that they provide on-going large-scale surveillance in the 'real-world' setting. Several studies have provided data on ADRs in children reported to national databases. EudraVigilance (EV) is the European Medicines Agency's (EMA) web-based system for reporting and evaluating suspected ADRs.

Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.

Background: Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from small differences in the manufacturing process. Detailed exposure information should be readily available in systems for postmarketing safety surveillance of biopharmaceuticals, including spontaneous reporting systems (SRSs), in which reports of ADRs are collected.

Objective: The aim of this study was to explore the current status of traceability of biopharmaceuticals in the US and the EU up to patient level in SRSs.

Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance.

The 14,543 spontaneous reports of suspected adverse reactions received in EudraVigilance from 1 November 2009 to 30 April 2010 for three centrally authorized Influenza A/H1N1 vaccines marketed in the European Economic Area (Celvapan, Focetria and Pandemrix) were extracted to evaluate the effectiveness of recommendations to strengthen pharmacovigilance systems during the pandemic and illustrate methods of signal detection used by the European Medicines Agency in this context. The number of vaccinees on 30 April 2010 was estimated to be at least 37,166,000 with a reporting rate of 391 per million vaccinees. 81.