Danish educational materials
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 |