Medicines authorised with a summary of the risk management plan (sRMP)

In connection with the approval of a risk management plan for a medicinal product for human use, a summary of the risk management plan for the medicinal product is prepared and made publicly available in accordance with the pharmacovigilance legislation which came into force in July 2012.

The summary is prepared by the marketing authorisation holder and approved by the Danish Medicines Agency. On the EMA's website, you can find the summaries of risk management plans for medicinal products with an authorisation granted under the Centralised Procedure.

You can find the summaries of risk management plans by searching for the product name or the active substance.

You can also find a summary of risk management plan by clicking the first letter of the relevant product name below.

Since medicinal products sometimes change names there can be divergent names in the summary of the risk management plan and on this website.

The name on the website will always be the most recently approved name for the product.

The name in the summary of the risk management plan can be a previously approved name of the product or the name(s) of the active substance(s).

Product Name Pharmaceutical Form Strength Active Substance Approval Date
Afluria injektionsvæske, suspension, fyldt injektionssprøjte; Influenzavirus A/California/07/2009 (H1N1) - deriveret stamme fra NYMC X-181, Influenzavirus A/Perth/16/2009 (H3N2) lignende stamme (A/Victoria/210/2009 NYMC X-187 reassortant), Influenzavirus B/Brisbane/60/2008, split virioner, inaktiveret 05/12/2017
Agomelatin "Glenmark" filmovertrukne tabletter; 25 mg Agomelatin 24/10/2018
Agomelatin "Mylan" filmovertrukne tabletter; 25 mg Agomelatin 26/07/2018
Agomelatin "Sandoz" filmovertrukne tabletter; 25 mg Agomelatin 24/05/2018
Agomelatin "Stada" filmovertrukne tabletter; 25 mg Agomelatin 26/07/2018
Agomelatin "Teva" filmovertrukne tabletter; 25 mg Agomelatin 11/05/2018
Agomelatine "Anpharm" filmovertrukne tabletter; 25 mg Agomelatin 02/08/2018
Agrippal injektionsvæske, suspension, fyldt injektionssprøjte; Influenzavirus A/California/07/2009 (H1N1) - deriveret stamme fra NYMC X-181, Influenzavirus A/Perth/16/2009 (H3N2) lignende stamme (A/Victoria/210/2009 NYMC X-187 reassortant), Influenzavirus B/Brisbane/60/2008 deriveret stamme, NYMC BX-35 reassortant 30/11/2017

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.


...