Notification on a suspected adverse reaction to a medicinal product/vaccine
- Public service
Information on adverse reactions to medicines and vaccines detected in Finland is collected in Fimea’s register of adverse reactions to which healthcare professionals and medicine users can report suspected or observed adverse reactions. The main purpose of the notification system is to detect unidentified rare adverse reactions. It is therefore hoped that adverse reactions not mentioned in the package leaflet of the medicinal product are reported in particular. The balance of benefits and adverse reactions of a medicinal product is continuously assessed as a whole, for example, in the light of information collected from adverse reaction notifications. Fimea does not confirm the receipt of the notification of adverse reactions separately or comment on it unless there is a need to request further clarifications.
Do the following
Adverse reactions can be reported using the adverse reaction notification form on the Fimea website, which is sent by post to Fimea.
You can also send corresponding information by post without the form.
The adverse reaction notification form can also be sent as secure mail to Fimea at FIMEA.EV@fimea.fi.
You can find more information about Fimea’s secure mail on Fimea’s website.
To whom and on what terms
The adverse reaction of a medicinal product has been observed in the patient or the user has observed it themselves.
The service is free of charge.