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
Toctino kapsler, bløde 10 mg ALITRETINOIN Stiefel Laboratories Legacy (Ireland) Limited 26/09/2018
Toctino kapsler, bløde 30 mg ALITRETINOIN Stiefel Laboratories Legacy (Ireland) Limited 26/09/2018
Topimax filmovertrukne tabletter 25 mg TOPIRAMAT Janssen-Cilag A/S 21/08/2024
Topimax filmovertrukne tabletter 50 mg TOPIRAMAT Janssen-Cilag A/S 21/08/2024
Topimax filmovertrukne tabletter 100 mg TOPIRAMAT Janssen-Cilag A/S 21/08/2024
Topimax filmovertrukne tabletter 200 mg TOPIRAMAT Janssen-Cilag A/S 21/08/2024
Topimax kapsler, hårde 15 mg TOPIRAMAT Janssen-Cilag A/S 21/08/2024
Topimax kapsler, hårde 25 mg TOPIRAMAT Janssen-Cilag A/S 21/08/2024
Topimax kapsler, hårde 50 mg TOPIRAMAT Janssen-Cilag A/S 21/08/2024
Topiramat "Actavis" filmovertrukne tabletter 100 mg TOPIRAMAT Actavis Group PTC ehf. 21/08/2024
Topiramat "Actavis" filmovertrukne tabletter 200 mg TOPIRAMAT Actavis Group PTC ehf. 21/08/2024
Topiramat "Actavis" filmovertrukne tabletter 25 mg TOPIRAMAT Actavis Group PTC ehf. 21/08/2024
Topiramat "Actavis" filmovertrukne tabletter 50 mg TOPIRAMAT Actavis Group PTC ehf. 21/08/2024
Topiramat "Aristo" filmovertrukne tabletter 50 mg TOPIRAMAT Aristo Pharma GmbH 21/08/2024
Topiramat "Aristo" filmovertrukne tabletter 25 mg TOPIRAMAT Aristo Pharma GmbH 21/08/2024
Topiramat "Orion" filmovertrukne tabletter 50 mg TOPIRAMAT Orion Corporation 21/08/2024
Topiramat "Orion" filmovertrukne tabletter 100 mg TOPIRAMAT Orion Corporation 21/08/2024
Topiramat "Orion" filmovertrukne tabletter 200 mg TOPIRAMAT Orion Corporation 21/08/2024
Topiramat "Orion" filmovertrukne tabletter 25 mg TOPIRAMAT Orion Corporation 21/08/2024
Topogyne tabletter 400 mikrogram MISOPROSTOL Exelgyn 05/08/2022
Toujeo DoubleStar injektionsvæske, opløsning i fyldt pen 300 enheder/ml Insulin glargin Sanofi-Aventis Deutschland GmbH 20/11/2023
Toujeo SoloStar injektionsvæske, opløsning i fyldt pen 300 enheder/ml Insulin glargin Sanofi-Aventis Deutschland GmbH 20/11/2023
Tozaron injektionsvæske, opløsning 1000 mg/4 ml TESTOSTERONUNDECANOAT Orifarm Healthcare A/S 22/08/2024