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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 

Name Medicine Type Strength Active substance Mft owner Publish Date
Fingolimod "Glenmark" kapsler, hårde 0,5 mg fingolimodhydrochlorid Glenmark Pharmaceuticals Nordic AB 10/05/2022
Fingolimod "Teva" kapsler, hårde 0,5 mg fingolimodhydrochlorid Teva GmbH 06/04/2022
Fingolimod "Tillomed" kapsler, hårde 0,5 mg fingolimodhydrochlorid Tillomed Pharma GmbH 08/12/2022
Fingolimod "Zentiva" kapsler, hårde 0,5 mg fingolimodhydrochlorid Zentiva k.s. 06/04/2022
Fintepla oral opløsning 2,2 mg/ml FENFLURAMINHYDROCHLORID UCB Pharma S.A. 30/06/2023
Flolan pulver og solvens til infusionsvæske, opløsning 500 mikrogram EPOPROSTENOL GlaxoSmithKline Pharma A/S 10/08/2017
Flolan pulver og solvens til infusionsvæske, opløsning 1,5 mg EPOPROSTENOLNATRIUM GlaxoSmithKline Pharma A/S 10/08/2017