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
Diafer injektionsvæske, opløsning; 50 mg/ml Ferriderisomaltose 06/04/2022
Dicloxacillin "Alternova" kapsler, hårde; 250 mg DICLOXACILLINNATRIUM (vandfrit) 03/09/2014
Dicloxacillin "Alternova" kapsler, hårde; 500 mg DICLOXACILLINNATRIUM (vandfrit) 03/09/2014
Dicloxacillin "Bluefish" kapsler, hårde; 250 mg DICLOXACILLINNATRIUM MONOHYDRAT 12/01/2019
Dicloxacillin "Bluefish" kapsler, hårde; 500 mg DICLOXACILLINNATRIUM MONOHYDRAT 12/01/2019
Dimenhydrinat "Galenica" resoribletter, sublinguale; 50 mg Dimenhydrinat 10/12/2014
Diovan oral opløsning; 3 mg/ml VALSARTAN 29/08/2019
Dipyridamol "Strides" depotkapsler, hårde; 200 mg Dipyridamol 10/10/2014
diTeBooster injektionsvæske, suspension, hætteglas; Clostridium tetani, stamme Albany Harvard 43415, toxoid, Corynebacterium diphtheriae, stamme Park Williams nr. 8, toxoid 22/08/2020
diTeBooster injektionsvæske, suspension, fyldt injektionssprøjte; Clostridium tetani, stamme Albany Harvard 43415, toxoid, Corynebacterium diphtheriae, stamme Park Williams nr. 8, toxoid 22/08/2020
diTekiBooster injektionsvæske, suspension, fyldt injektionssprøjte; Bordetella pertussis, stamme CS-87, toxoid, Clostridium tetani, stamme Albany Harvard 43415, toxoid, Corynebacterium diphtheriae, stamme Park Williams nr. 8, toxoid 05/09/2013
Divisun tabletter; 100 mikrogram Cholecalciferol 22/10/2015
Divisun tabletter; 20 mikrogram CHOLECALCIFEROLDILUENDUM 22/10/2015
Divisun tabletter; 25 mikrogram Cholecalciferol 22/10/2015
Divisun tabletter; 50 mikrogram Cholecalciferol 22/10/2015