SmPCs and PLs
SmPCs and PLs
The Finnish Medicines Agency Fimea publishes on its website Summaries of Product Characteristics (SmPC) and Package Leaflets (PL) for all medicinal products approved by Fimea through a national, decentralised or mutual recognition procedure. All the products and package sizes mentioned in the documents are not necessarily for sale in Finland.
Product documentation of medicinal products that have been granted a marketing authorisation through the centralised procedure is published by the European Medicines Agency, EMA. Fimea's service contains links to the documents on medicinal products (EPAR PI) on the EMA website.
The Summary of Product Characteristics includes the essential facts for the medicinal product or herbal medicinal product that a health care professional should know.
The Package Leaflet provides users with information about the product and its correct use.
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 (NAM) 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 granted, are conclusive.
Inquiries concerning medical therapy, users of medicinal products are requested to contact the attending doctor or pharmacy. For inquiries concerning veterinary medicines please address questions to the attending veterinarian or pharmacy.