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
Remsima injektionsvæske, opløsning i fyldt injektionssprøjte 120 mg INFLIXIMAB Celltrion Healthcare Hungary Kft 18/03/2024
Remsima injektionsvæske, opløsning i fyldt pen 120 mg INFLIXIMAB Celltrion Healthcare Hungary Kft 18/03/2024
Remsima pulver til koncentrat til infusionsvæske, opløsning 100 mg INFLIXIMAB Celltrion Healthcare Hungary Kft 18/03/2024
Replagal koncentrat til infusionsvæske, opløsning 1 mg/ml AGALSIDASE ALFA Takeda Pharmaceuticals International AG Ireland Branch 03/03/2023
Revlimid kapsler, hårde 5 mg Lenalidomid Bristol-Myers Squibb Pharma EEIG 16/01/2024
Revlimid kapsler, hårde 10 mg Lenalidomid Bristol-Myers Squibb Pharma EEIG 16/01/2024
Revlimid kapsler, hårde 15 mg Lenalidomid Bristol-Myers Squibb Pharma EEIG 16/01/2024
Revlimid kapsler, hårde 2,5 mg Lenalidomid Bristol-Myers Squibb Pharma EEIG 16/01/2024
Revlimid kapsler, hårde 7,5 mg Lenalidomid Bristol-Myers Squibb Pharma EEIG 16/01/2024
Revlimid kapsler, hårde 20 mg Lenalidomid Bristol-Myers Squibb Pharma EEIG 16/01/2024