Fimea

The package leaflet (PL) containing information for the user of the medicine is found in the package. It includes user friendly instructions for correct and safe use and about any potential undesirable effects of the medicine. The package leaflet also contains instructions for handling of the waste from medicinal products. The package leaflets include instructions in both Finnish and Swedish.

The package leaflet can be searched from alphabetical list, with the name, Anatomical Therapeutic Chemical, i.e. ATC Code or marketing authorisation number of medicinal product.

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.

Product Information Leaflets 1 - 30 of 54

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SPC

Status for
supply

Name of the medicinal product

European Medicines Agency's website:
Fatrovax RHD - EMA: EPAR PI
Finnish Swedish

Package Leaflets (PL) for Veterinary medicinal products