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
Ambrisentan "Accord" filmovertrukne tabletter 5 mg Ambrisentan Accord Healthcare B.V. 18/09/2020
Ambrisentan "Accord" filmovertrukne tabletter 10 mg Ambrisentan Accord Healthcare B.V. 18/09/2020
Ambrisentan "Mylan" filmovertrukne tabletter 5 mg Ambrisentan Mylan Pharmaceuticals Limited 12/10/2023
Ambrisentan "Mylan" filmovertrukne tabletter 10 mg Ambrisentan Mylan Pharmaceuticals Limited 12/10/2023
Ambrisentan "Sandoz" filmovertrukne tabletter 5 mg Ambrisentan Sandoz A/S 14/08/2020
Ambrisentan "Sandoz" filmovertrukne tabletter 10 mg Ambrisentan Sandoz A/S 14/08/2020
Ambrisentan "Teva" filmovertrukne tabletter 5 mg Ambrisentan Teva B.V. 02/06/2021
Ambrisentan "Teva" filmovertrukne tabletter 10 mg Ambrisentan Teva B.V. 02/06/2021
Amorina tabletter 0,250+0,035 mg Ethinylestradiol, NORGESTIMAT EFFIK S.A. 03/12/2021
Apixaban "Sandoz" filmovertrukne tabletter 2,5 mg Apixaban Sandoz A/S 08/03/2024
Apixaban "Sandoz" filmovertrukne tabletter 5 mg Apixaban Sandoz A/S 08/03/2024