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        • Summary of Product Characteristics is to be available also in Swedish
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  • Summary of Product Characteristics is to be available also in Swedish

Summary of Product Characteristics is to be available also in Swedish

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Frequently asked questions

  • How to submit a Swedish summary of product characteristics to Fimea?
  • What should be attached to the application for addition?
  • Is it possible to submit a Swedish summary of product characteristics for a product family in one application?
  • In connection with submitting a Swedish summary of product characteristics, is it possible to make changes also to the package leaflet?
  • In connection with submitting a Swedish summary of product characteristics, it possible to make other changes to the SPC?
  • How does the need for Swedish summary of product characteristics affect the centralised medicines?
  • Does the submission of the summary of product characteristics in Swedish apply also for veterinary medicinal products?
  • When should a summary of product characteristics in Swedish be submitted?
  • How should the summary of product characteristics in Swedish be submitted for new Marketing Authorisation applications, which are currently under assessment?
  • Can the submission of the summary of product characteristics in Swedish be combined with some other kind of variation application?
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