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Actu Pharmacovigilance
L'actualité réglementaire de la pharmacovigilance en Europe
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European Medicines Agency - European Medicines Agency website on suspected side effect reports now in all 23 EU official languages

The European Medicines Agency has launched its website on suspected side-effect reports for medicines authorised in the European Economic Area (EEA) in the remaining 22 official European Union (EU) languages.

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European database of suspected adverse drug reaction reports

European database of suspected adverse drug reaction reports | Actu Pharmacovigilance |

On this website you can view data on suspected side-effects also known as suspected adverse drug reactions for authorised medicines in the European Economic Area (EEA).

This data is presented in a format called a web report.

Currently the data only relates to medicines approved through the centralised authorisation procedure.

The information on this website relates to suspected side effects, i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine.

Information on suspected side effects should not be interpreted as meaning that the medicine or the active substance causes the observed effect or is unsafe to use. Only a detailed evaluation and scientific assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of a medicine.

The European Medicines Agency publishes this data so that its stakeholders, including the general public, can access information that European regulatory authorities use to review the safety of a medicine or active substance. Transparency is a key guiding principle of the Agency.

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