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
Airbufo Forspiro inhalationspulver, afdelt; 160+4,5 mikrog/dosis BUDESONID, FORMOTEROLFUMARAT DIHYDRAT 12/04/2018
AirFluSal Sprayhaler inhalationsspray, suspension; 25+125 mikrog./dosis FLUTICASONPROPIONAT, SALMETEROLXINAFOAT 16/03/2017
AirFluSal Sprayhaler inhalationsspray, suspension; 25+250 mikrog./dosis FLUTICASONPROPIONAT, SALMETEROLXINAFOAT 16/03/2017
Aklief creme; 50 mikrogram/g Trifaroten 18/12/2019
Aktiprol tabletter; 100 mg AMISULPRID 20/04/2015
Aktiprol tabletter; 200 mg AMISULPRID 20/04/2015
Aktiprol tabletter; 400 mg AMISULPRID 20/04/2015
Aktiprol tabletter; 50 mg AMISULPRID 20/04/2015
Alacare medicinsk plaster; 8 mg 5-AMINOLEVULINSYRE
Albumin "Behring" infusionsvæske, opløsning; 200 g/l ALBUMIN, HUMAN 02/04/2015
Alchetimibel tabletter; 10 mg EZETIMIB 20/12/2016
Alendronat "Mylan" tabletter; 10 mg Natriumalendronattrihydrat 15/01/2017
Alendronat "Mylan" tabletter; 70 mg Natriumalendronattrihydrat 15/01/2017
Alendronat/Cholecalciferol "Aristo" tabletter; 70 mg+140 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Alendronat/Cholecalciferol "Aristo" tabletter; 70 mg+70 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Alendronat/Cholecalciferol "BGR" tabletter; 70 mg+140 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Alendronat/Cholecalciferol "BGR" tabletter; 70 mg+70 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Alendronat/Cholecalciferol "Stada" tabletter; 70 mg+140 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Alendronat/Cholecalciferol "Stada" tabletter; 70 mg+70 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Alendronat/Cholecalciferol "Zentiva" tabletter; 70 mg+140 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Alendronat/Cholecalciferol "Zentiva" tabletter; 70 mg+70 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Alendronate/Cholecalciferol "Accord" tabletter; 70 mg+140 mikrogram ALENDRONSYRE, Cholecalciferoltrituration 24/10/2018
Alendronate/Cholecalciferol "Accord" tabletter; 70 mg+70 mikrogram ALENDRONSYRE, Cholecalciferoltrituration 24/10/2018
Alfacalcidol "Aristo" kapsler, bløde; 0,25 mikrogram ALFACALCIDOL 15/03/2017
Alfacalcidol "Aristo" kapsler, bløde; 0,5 mikrogram ALFACALCIDOL 15/03/2017
Alfacalcidol "Strides" kapsler, bløde; 0,25 mikrogram ALFACALCIDOL 09/07/2014
Alfacalcidol "Strides" kapsler, bløde; 0,5 mikrogram ALFACALCIDOL 09/07/2014
Alfacalcidol "Strides" kapsler, bløde; 1 mikrogram ALFACALCIDOL 09/07/2014
Alfuzosin "Orion" depottabletter; 10 mg ALFUZOSINHYDROCHLORID 20/05/2016
Alfuzosin "Orion" filmovertrukne tabletter; 2,5 mg ALFUZOSINHYDROCHLORID 20/05/2016
Alitretinoin "Orifarm" kapsler, bløde; 10 mg ALITRETINOIN 26/02/2020
Alitretinoin "Orifarm" kapsler, bløde; 30 mg ALITRETINOIN 26/02/2020
Allopurinol "Accord" tabletter; 100 mg ALLOPURINOL 20/03/2019
Allopurinol "Accord" tabletter; 300 mg ALLOPURINOL 20/03/2019
Allopurinol "Mylan" tabletter; 100 mg ALLOPURINOL 04/10/2017
Allopurinol "Mylan" tabletter; 300 mg ALLOPURINOL 04/10/2017
Allopurinol "Orion" tabletter; 100 mg ALLOPURINOL 24/05/2018
Allopurinol "Orion" tabletter; 300 mg ALLOPURINOL 24/05/2018
Allopurinol "Sandoz" tabletter; 100 mg ALLOPURINOL 31/05/2016
Allopurinol "Sandoz" tabletter; 300 mg ALLOPURINOL 31/05/2016
Alnodine filmovertrukne tabletter; 120 mg FEXOFENADINHYDROCHLORID 26/10/2016
Alnodine filmovertrukne tabletter; 180 mg FEXOFENADINHYDROCHLORID 26/10/2016
Alprazolam "Krka d.d." tabletter; 0,25 mg ALPRAZOLAM 20/07/2018
Alprazolam "Krka d.d." tabletter; 0,5 mg ALPRAZOLAM 20/07/2018
Alprazolam "Krka d.d." tabletter; 1 mg ALPRAZOLAM 20/07/2018
Alprazolam "Krka d.d." tabletter; 2 mg ALPRAZOLAM 20/07/2018

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