Danish educational materials

02 February 2023

From November 15th 2016 the Danish Medicines Agency published Danish educational materials for human medicinal products approved via the national procedure, the mutual recognition procedure and the decentralised procedure.

From January 1st 2023 and forward – and not retroactively - the Danish Medicines Agency also publishes Danish educational materials for human medicinal products approved via the centralised procedure.

The marketing authorisation holder has the overall responsibility for the educational material and for ensuring that it complies with the conditions of the marketing authorisation. The marketing authorisation holder also has the overall responsibility for ensuring that the Danish Medicines Agency has the latest accepted written educational material available for publication.

Please refer to the section Dansk uddannelsesmateriale for the accepted and published Danish educational materials 

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Name Medicine Type Strength Active substance Mft owner Publish Date
Ultomiris koncentrat til infusionsvæske, opløsning 300 mg/30 ml Ravulizumab Alexion Europe SAS 07/09/2023
Ultomiris koncentrat til infusionsvæske, opløsning 1100mg/11 ml Ravulizumab Alexion Europe SAS 09/12/2024
Ultomiris koncentrat til infusionsvæske, opløsning 300mg/3 ml Ravulizumab Alexion Europe SAS 09/12/2024