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Summaries of product characteristics

Updated 12 April 2013

Produktresume.dk

At produktresume.dk, you can download the summaries of product characteristics of medicines authorised for sale in Denmark. They are worded in Danish and updated on a weekly basis to implement any authorised changes, etc.

Which medicines are described?

Not all authorised medicines have been placed on the market in Denmark, because some companies choose not to market their products even though they are authorised to do so.

You can find information about medicines marketed in Denmark under "Medicine Prices", which also lists consumer prices for all packages. This information is updated every fortnight.

Centrally authorised medicines on EMA's website

The approved summaries of product characteristics for medicines with a centrally granted marketing authorisation can be downloaded from the EMA website.

  1. Human medicines
  2. Veterinary medicines

When you click the name of a product, a list is displayed with the authorised summary of product characteristics (in the national languages).

About summaries of product characteristics

The summary of product characteristics (SPC) describes the properties and conditions for use of a particular medicinal product. The summaries of product characteristics are approved by the Danish Health and Medicines Authority and contain a wealth of information about the product, i.a.:

  • Composition (declaration)
  • Pharmaceutical form and strength
  • Approved applications (indications)
  • Side effects
  • Warnings and precaution for use
  • Shelf life
  • Storage conditions
  • Manufacturer/importer