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Responsible for the service Finnish Medicines Agency Fimea

Summaries of product characteristics and package leaflets

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A summary of product characteristics (SPC) contains the key information about a product with marketing authorisation. The SPC has to be in Finnish and in Swedish. For common European procedures (CP, MRP, DCP), the Finnish and Swedish SPC must be a translation of the English common SPC.

Fimea publishes the summaries of product characteristics for products that have been granted marketing authorisa ...

Text edited by: Finnish Medicines Agency Fimea
Updated: 19/3/2021