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
Dronedaron "Aristo" filmovertrukne tabletter; 400 mg Dronedaronhydrochlorid 25/04/2019
Dronedarone "Stada" filmovertrukne tabletter; 400 mg Dronedaronhydrochlorid 03/04/2020
Droperidol "Sintetica" injektionsvæske, opløsning; 0,5 mg/ml Droperidol 06/06/2023
Dropizol orale dråber, opløsning; 10 mg/ml OPIUM 19/07/2019
Duciltia enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 23/05/2024
Duciltia enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 23/05/2024
Ducressa øjendråber, opløsning; 1+5 mg/ml DEXAMETHASONNATRIUMPHOSPHAT, LEVOFLOXACINHEMIHYDRAT 28/05/2020
Duloxetin "Hexal" enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 18/12/2015
Duloxetin "Hexal" enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 18/12/2015
Duloxetin "Krka" enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 17/02/2015
Duloxetin "Krka" enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 17/02/2015
Duloxetin "Stada Arzneimittel AG" enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 17/06/2015
Duloxetin "Stada Arzneimittel AG" enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 17/06/2015
Duloxetin "Stada" enterokapsler, hårde; 20 mg DULOXETINHYDROCHLORID 13/07/2015
Duloxetin "Stada" enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 24/07/2015
Duloxetin "Stada" enterokapsler, hårde; 40 mg DULOXETINHYDROCHLORID 13/07/2015
Duloxetin "Stada" enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 24/07/2015
Duloxetine "Accord" enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 09/09/2015
Duloxetine "Accord" enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 09/09/2015
Duloxetine "Medical Valley" enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 10/08/2017
Duloxetine "Medical Valley" enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 10/08/2017
Duloxetine "Orion" enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 18/06/2015
Duloxetine "Orion" enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 18/06/2015
Duodopa enteralgel; 20+5 mg/ml CARBIDOPA, LEVODOPA 13/03/2017
Duodopa infusionsvæske, opløsning; 240+12 mg/ml Foscarbidopa, Foslevodopa 27/07/2022
Duokopt øjendråber, opløsning; 20+5 mg/ml DORZOLAMIDHYDROCHLORID, TIMOLOLMALEAT 26/09/2018
Duonasa næsespray, suspension; 137+50 mikrogram/pust AZELASTINHYDROCHLORID, FLUTICASONPROPIONAT 31/08/2023
Duosol Kalium 2 mmol/l hæmofiltreringsvæske; 2 millimol/l CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, KALIUMCHLORID, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 01/03/2017
Duosol Kalium 4 mmol/l hæmofiltreringsvæske; 4 millimol/l CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, KALIUMCHLORID, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 01/03/2017
Duosol Kaliumfri hæmofiltreringsvæske; CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 01/03/2017
Dutasterid "Alkaloid" kapsler, bløde; 0,5 mg DUTASTERID 12/09/2018
Dutasterid "Hexal" kapsler, bløde; 0,5 mg DUTASTERID 27/07/2016
Dutasterid "Laboratorios León Farma" kapsler, bløde; 0,5 mg DUTASTERID 12/02/2021
Dutasterid "Laboratorios Liconsa" kapsler, bløde; 0,5 mg DUTASTERID 10/05/2019
Dutasterid "Liconsa" kapsler, bløde; 0,5 mg DUTASTERID 12/02/2021
Dutasterid "Mylan" kapsler, bløde; 0,5 mg DUTASTERID 26/11/2018
Dutasterid "Universal Farma" kapsler, bløde; 0,5 mg DUTASTERID 12/02/2021
Dutasterid/Tamsulosinhydrochlorid "G.L. Pharma" kapsler, hårde; 0,5+0,4 mg DUTASTERID, TAMSULOSINHYDROCHLORID 14/08/2019
Dutasterid/Tamsulosinhydrochlorid "Glenmark" kapsler, hårde; 0,5+0,4 mg DUTASTERID, TAMSULOSINHYDROCHLORID 14/08/2019
Dutasteride "Krka" kapsler, bløde; 0,5 mg DUTASTERID 17/11/2016
Dutasteride "Medical Valley" kapsler, bløde; 0,5 mg DUTASTERID 12/02/2021
Dutrys kapsler, bløde; 0,5 mg DUTASTERID 17/11/2016