Dihydroergotamine and dihydroergotoxine: unfavourable risk-benefit ratio
2022.03.11
Active substance: dihydroergotamine | dihydroergotoxine
11.03.2022 - Note
No more dihydroergotamine-containing medicinal products are approved in Germany. The risk assessment procedure for medicinal products containing dihydroergotamine is therefore currently no longer relevant for medicinal products approved in Germany.
13.01.2020 - Further suspension of the marketing authorisations
In a notice dated 10. January 2020, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled further suspension of marketing authorisation until 01. February 2022.
15.01.2018 - Further suspension of the marketing authorisations
In a notice dated 15. January 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled further suspension of marketing authorisation until 01. February 2020.
29.01.2016 - Further suspension of the marketing authorisations
In a notice dated 27. January 2016, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled further suspension of marketing authorisation by two years (for the time being) for medicinal products containing the active substance dihydroergotamine as well as for medicinal products containing the active substance dihydroergotoxine.
03.02.2015 - Suspension of the marketing authorisations
The Federal Institute for Drugs and Medical Devices has ruled further suspension of marketing authorisation by one year (for the time being) for medicinal products containing the active substance dihydroergotamine as well as for medicinal products containing the active substance dihydroergotoxine.
01.04.2014 - Hearing and notice within the graduated plan procedure ("Stufenplanverfahren")
In its notice dated 27 November 2013 for medicinal products with the active substance dihydroergotamine as well as its notice of 18 March 2014 for medicinal products with the active substance dihydroergotoxine the Federal Institute for Drugs and Medical Devices has ruled the realisation of the of the corresponding implementing decisions of the European Commission in the European safety review on various ergot derivatives.
Further information
For further information please click on the following link to the homepage of the European Medicines Agency (EMA):
To the risk assessment procedure (available in German only)