The package leaflet (PL) provides users with information about the medicinal product and its correct use. The package leaflets contain instructions in both Finnish and Swedish.
The package leaflets can be searched from alphabetical list, with the name, marketing authorisation number and the Anatomical Therapeutic Chemical, i.e. ATC Code of the Summary of Product Characteristics, SPC.
The package leaflets processed as part of the EU centralised marketing authorisation procedure are published by the European Medicines Agency, EMA
Fimea's service contains links to the documents on medicinal products (EPAR PI) on the EMA website.
Drugs belonging to the centralised authorisation procedure can be searched in Fimea's service by using an alphabetical list or by entering the product name or ATC code.
The material being published is not necessarily complete or up-to-date due to the technical quality of files submitted to the Finnish Medicines Agency Fimea or earlier to the National Agency for Medicines and the delays in delivery. For this reason, Fimea cannot guarantee that the document on the Internet fully complies with the summary of product characteristics and package leaflet officially approved by a desicion for a marketing authorisation. Only the hard copies of the SPCs and the PLs, which are in accordance with the marketing authorisation, are conclusive.