The European Medicines Agency is responsible for hosting and maintaining EudraVigilance, a system designed for collecting reports of suspected side effects, used for evaluating the benefits and risks of medicines during their development and monitoring their safety following their authorisation in the European Economic Area (EEA).
The data displayed on this website through the web reports are submitted electronically to EudraVigilance by national medicines regulatory authorities and by marketing-authorisation holders (pharmaceutical companies). As a result, the Agency has limited control over the completeness or accuracy of the information available.
The Agency does carry out quality reviews in EudraVigilance, which includes identifying duplicate reports, performing the coding of the reported medicines and reported active substances, and providing feedback on the quality of information sent by national medicines regulatory agencies and marketing-authorisation holders.
The ongoing review of EudraVigilance data increases the quality of the information provided on this website.
The information in EudraVigilance evolves on a daily basis, and the number of individual cases may increase or decrease. It is therefore possible that the information published on this website through the web reports may change over time.
A decrease in the number of individual cases displayed in a web report can be explained by the following principal reasons:
- a follow-up report of an existing individual case is received where the reported medicine, reported active substance or reported suspected side effect is modified by the reporter, based on new information;
- a report is submitted by more than one reporter (e.g. a pharmacist and a doctor); during quality-review, these duplicate reports can be identified and are combined into a single report;
- a report is removed at the sender's request, usually due to the report being erroneous.