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 |
Sebadrin | injektionsvæske, opløsning; | 50 mg/ml | EPHEDRINHYDROCHLORID | 21/12/2021 |
Sedaconda | væske til inhalationsdamp; | 100 % | ISOFLURAN | 20/07/2021 |
Sefitude | overtrukne tabletter; | VALERIANE ekstrakt, tørret | 16/10/2017 | |
Sekua | øjendråber, opløsning, enkeltdosisbeholder; | 0,9 mg/ml | CICLOSPORIN | 27/03/2024 |
Selesyn | injektions-/infusionsvæske, opløsning; | 100 mikrogram | Natriumselenitpentahydrat | 03/06/2021 |
Selesyn | oral opløsning; | 100 mikrogram | Natriumselenitpentahydrat | 03/06/2021 |
Selesyn | tabletter; | 100 mikrogram | Natriumselenitpentahydrat | 17/03/2021 |
Selesyn | tabletter; | 200 mikrogram | Natriumselenitpentahydrat | 17/03/2021 |
Selesyn | tabletter; | 300 mikrogram | Natriumselenitpentahydrat | 05/09/2018 |
Selesyn | tabletter; | 50 mikrogram | Natriumselenitpentahydrat | 17/03/2021 |
Selesyn | injektions-/infusionsvæske, opløsning; | 50 mikrogram/ml | Natriumselenitpentahydrat | 03/06/2021 |
Selesyn | oral opløsning; | 50 mikrogram/ml | Natriumselenitpentahydrat | 03/06/2021 |
Sendolor | infusionsvæske, opløsning; | 1 mg/ml | Morphinhydrochloridtrihydrat | 20/04/2017 |
Sendolor | injektionsvæske, opløsning; | 1 mg/ml | Morphinhydrochloridtrihydrat | 20/04/2017 |
Sendolor | infusionsvæske, opløsning; | 10 mg/ml | Morphinhydrochloridtrihydrat | 20/04/2017 |
Sendolor | injektionsvæske, opløsning; | 10 mg/ml | Morphinhydrochloridtrihydrat | 20/04/2017 |
Sendolor | infusionsvæske, opløsning; | 20 mg/ml | Morphinhydrochloridtrihydrat | 20/04/2017 |
Sendolor | injektionsvæske, opløsning; | 20 mg/ml | Morphinhydrochloridtrihydrat | 20/04/2017 |
Septabene | mundhulespray, opløsning; | 1,5+5 mg/ml | Benzydaminhydrochlorid, CETYLPYRIDINIUMCHLORID, MONOHYDRAT | 17/05/2021 |
Septabene citron og honning | sugetabletter; | 3+1 mg | Benzydaminhydrochlorid, CETYLPYRIDINIUMCHLORID, MONOHYDRAT | 17/05/2021 |
Septanest | injektionsvæske, opløsning; | 40 mg/ml+5 mikrog/ml | ADRENALINTARTRAT, Articainhydrochlorid | 30/06/2014 |
Septocaine | injektionsvæske, opløsning; | 40 mg/ml+10mikrog/ml | ADRENALINTARTRAT, Articainhydrochlorid | 30/06/2014 |
Seractiv | filmovertrukne tabletter; | 300 mg | DEXIBUPROFEN | 27/06/2017 |
Seractiv | filmovertrukne tabletter; | 400 mg | DEXIBUPROFEN | 27/06/2017 |
Serdolect | filmovertrukne tabletter; | 12 mg | Sertindol | 24/11/2021 |
Serdolect | filmovertrukne tabletter; | 16 mg | Sertindol | 24/11/2021 |
Serdolect | filmovertrukne tabletter; | 20 mg | Sertindol | 24/11/2021 |
Serdolect | filmovertrukne tabletter; | 4 mg | Sertindol | 24/11/2021 |
Serefarm | inhalationspulver, afdelt; | 50+100 mikrogram/dosis | FLUTICASONPROPIONAT, SALMETEROLXINAFOAT | 27/04/2022 |
Serefarm | inhalationspulver, afdelt; | 50+250 mikrogram/dosis | FLUTICASONPROPIONAT, SALMETEROLXINAFOAT | 27/04/2022 |
Serefarm | inhalationspulver, afdelt; | 50+500 mikrogram/dosis | FLUTICASONPROPIONAT, SALMETEROLXINAFOAT | 27/04/2022 |
Seretide | inhalationspulver, afdelt; | 50+100 mikrog./dosis | FLUTICASONPROPIONAT, SALMETEROLXINAFOAT | 03/09/2014 |
Seretide | inhalationspulver, afdelt; | 50+250 mikrog./dosis | FLUTICASONPROPIONAT, SALMETEROLXINAFOAT | 03/09/2014 |
Seretide | inhalationspulver, afdelt; | 50+500 mikrog./dosis | FLUTICASONPROPIONAT, SALMETEROLXINAFOAT | 03/09/2014 |
Seroquel Prolong | depottabletter; | 150 mg | QUETIAPIN FUMARAT | 21/10/2015 |
Seroquel Prolong | depottabletter; | 200 mg | QUETIAPIN FUMARAT | 21/10/2015 |
Seroquel Prolong | depottabletter; | 300 mg | QUETIAPIN FUMARAT | 21/10/2015 |
Seroquel Prolong | depottabletter; | 50 mg | QUETIAPIN FUMARAT | 21/10/2015 |
Sertralin "Zentiva" | filmovertrukne tabletter; | 25 mg | SERTRALINHYDROCHLORID | 18/08/2021 |
Sertraline "Orifarm" | filmovertrukne tabletter; | 25 mg | SERTRALINHYDROCHLORID | 13/04/2022 |
Sertramyl | filmovertrukne tabletter; | 100 mg | SERTRALINHYDROCHLORID | 03/08/2017 |
Sertramyl | filmovertrukne tabletter; | 50 mg | SERTRALINHYDROCHLORID | 03/08/2017 |
Sevelamer "Sandoz" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 06/03/2017 |
Sevelamercarbonat "Aurobindo" | pulver til oral suspension; | 2,4 g | sevelamer carbonate | 09/03/2023 |
Sevelamercarbonat "Aurobindo" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 12/03/2014 |
Sevelamercarbonat "Genthon" | pulver til oral suspension; | 2,4 g | sevelamer carbonate | 12/12/2018 |
Sevelamercarbonat "Genthon" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 12/12/2018 |
Sevelamercarbonat "Heumann" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 23/02/2023 |
Sevelamercarbonat "Mylan" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 13/05/2016 |
Sevelamercarbonat "Sandoz" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 12/09/2017 |
Sevelamercarbonat "Stada Arzneimittel AG" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 31/07/2020 |
Sevelamercarbonat "Stada" | pulver til oral suspension; | 2,4 g | sevelamer carbonate | 15/09/2016 |
Sevelamercarbonat "Stada" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 31/07/2020 |
Sevelamercarbonat "Synthon" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 12/12/2018 |
Sevelamercarbonat "Viatris Pharma" | pulver til oral suspension; | 2,4 g | sevelamer carbonate | 15/09/2016 |
Sevelamercarbonat "Zentiva" | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 18/05/2017 |
Sevelamerhydrochlorid "Waymade" | filmovertrukne tabletter; | 800 mg | Sevelamerhydrochlorid | 15/08/2019 |
Sevemed | filmovertrukne tabletter; | 800 mg | sevelamer carbonate | 12/03/2014 |