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This website was launched by the European Medicines Agency in 2012 to provide public access to reports of suspected side effects (also known as suspected adverse drug reactions) observed following administration of human medicines. In 2019 the website was extended to provide corresponding information on suspected adverse events following administration of veterinary medicines as well. |
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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. |
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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. |
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The European Medicines Agency publishes these 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. |
Reports on suspected side effects are processed by national medicines regulatory authorities and marketing authorisation holders and submitted to EudraVigilance Veterinary in line with applicable data protection rules as set out in the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679 ).
Reports of suspected side effects submitted to EudraVigilance Veterinary are processed by the European Medicines Agency in line with applicable data-protection rules as set out in the EU DPR, Regulation (EU) 2018/1725.
For information on the processing of personal data by EMA please read our Privacy Statement: https://www.ema.europa.eu/en/about-us/legal/privacy-statement
In case you have any questions, please contact dataprotection@ema.europa.eu
