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
Dabigatran etexilate "Glenmark" kapsler, hårde 75 mg Dabigatranetexilatmesilat Glenmark Arzneimittel GmbH 08/10/2024
Dabigatran etexilate "Glenmark" kapsler, hårde 150 mg Dabigatranetexilatmesilat Glenmark Arzneimittel GmbH 08/10/2024
Dabigatran etexilate "Glenmark" kapsler, hårde 110 mg Dabigatranetexilatmesilat Glenmark Arzneimittel GmbH 08/10/2024
Dabigatran etexilate "Krka" kapsler, hårde 75 mg Dabigatranetexilatmesilat KRKA d.d. Novo mesto 29/11/2024
Dabigatran etexilate "Krka" kapsler, hårde 110 mg Dabigatranetexilatmesilat KRKA d.d. Novo mesto 29/11/2024
Dabigatran etexilate "Krka" kapsler, hårde 150 mg Dabigatranetexilatmesilat KRKA d.d. Novo mesto 29/11/2024
Dabigatran etexilate "Orion" kapsler, hårde 75 mg Dabigatranetexilatmesilat Orion Corporation 25/11/2024
Dabigatran etexilate "Orion" kapsler, hårde 110 mg Dabigatranetexilatmesilat Orion Corporation 25/11/2024
Dabigatran etexilate "Orion" kapsler, hårde 150 mg Dabigatranetexilatmesilat Orion Corporation 25/11/2024
Dabigatran etexilate "Sandoz" kapsler, hårde 75 mg Dabigatranetexilatmesilat Sandoz A/S 26/10/2023
Dabigatran etexilate "Sandoz" kapsler, hårde 110 mg Dabigatranetexilatmesilat Sandoz A/S 26/10/2023
Dabigatran etexilate "Sandoz" kapsler, hårde 150 mg Dabigatranetexilatmesilat Sandoz A/S 26/10/2023
Dabigatran etexilate Accord kapsler, hårde 75 mg Dabigatranetexilatmesilat Accord Healthcare S.L.U. 04/01/2024
Dabigatran etexilate Accord kapsler, hårde 110 mg Dabigatranetexilatmesilat Accord Healthcare S.L.U. 04/01/2024
Dabigatran etexilate Accord kapsler, hårde 150 mg Dabigatranetexilatmesilat Accord Healthcare S.L.U. 04/01/2024
Dabigatran etexilate Leon Farma kapsler, hårde 150 mg Dabigatranetexilatmesilat Laboratorios Leon Farma, S.A. 30/09/2024
Dabigatran etexilate Leon Farma kapsler, hårde 110 mg Dabigatranetexilatmesilat Laboratorios Leon Farma, S.A. 30/09/2024
Dabigatran Etexilate Leon Farma kapsler, hårde 75 mg Dabigatranetexilatmesilat Laboratorios Leon Farma, S.A. 30/09/2024