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
Abacavir/Lamivudin "Mylan" filmovertrukne tabletter; 600 mg/300 mg Abacavirhydrochlorid, LAMIVUDIN 18/04/2016
Abacavir/Lamivudin "Vale" filmovertrukne tabletter; 600+300 mg Abacavirsulfat, LAMIVUDIN 01/09/2017
Abacavir/Lamivudine "Glenmark" filmovertrukne tabletter; 600+300 mg Abacavir, LAMIVUDIN 13/04/2018
Abacavir/Lamivudine "Stada" filmovertrukne tabletter; 600 mg+300 mg Abacavir, LAMIVUDIN 01/03/2016
Abacavir/Lamivudine "Teva" filmovertrukne tabletter; 600+300 mg Abacavirhydrochlorid, LAMIVUDIN 29/04/2016
Abstral resoribletter, sublinguale; 100 mikrogram FENTANYLCITRAT 02/10/2014
Abstral resoribletter, sublinguale; 200 mikrogram FENTANYLCITRAT 02/10/2014
Abstral resoribletter, sublinguale; 300 mikrogram FENTANYLCITRAT 02/10/2014
Abstral resoribletter, sublinguale; 400 mikrogram FENTANYLCITRAT 02/10/2014
Abstral resoribletter, sublinguale; 600 mikrogram FENTANYLCITRAT 02/10/2014
Abstral resoribletter, sublinguale; 800 mikrogram FENTANYLCITRAT 02/10/2014
Acarizax frysetørret tablet; 12 SQ-HDM Dermatophagoides farinae, Dermatophagoides pteronyssinus 30/08/2015
Acetylsalicylsyre "Teva" tabletter; 150 mg ACETYLSALICYLSYRE 20/09/2016
Acetylsalicylsyre "Teva" tabletter; 160 mg ACETYLSALICYLSYRE 20/09/2016
Acetylsalicylsyre "Teva" tabletter; 75 mg ACETYLSALICYLSYRE 20/09/2016
Aciclovir "Alternova" tabletter; 200 mg ACICLOVIR 07/01/2016
Acitretin "Orifarm" kapsler, hårde; 10 mg ACITRETIN 10/07/2017
Acitretin "Orifarm" kapsler, hårde; 25 mg ACITRETIN 10/07/2017
Aclonia tabletter; 70 mg+140 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Aclonia tabletter; 70 mg+70 mikrogram Cholecalciferol, Natriumalendronattrihydrat 03/05/2017
Acnenor kapsler, bløde; 10 mg Isotretinoin 04/12/2016
Acnenor kapsler, bløde; 20 mg Isotretinoin 04/12/2016
Actilyse pulver og solvens til injektions- /infusionsvæske, opløsning; ALTEPLASE 06/06/2018
Actiq sugetabletter; 1200 mikrogram FENTANYLCITRAT 31/08/2016
Actiq sugetabletter; 1600 mikrogram FENTANYLCITRAT 31/08/2016
Actiq sugetabletter; 200 mikrogram FENTANYLCITRAT 31/08/2016
Actiq sugetabletter; 400 mikrogram FENTANYLCITRAT 31/08/2016
Actiq sugetabletter; 600 mikrogram FENTANYLCITRAT 31/08/2016
Actiq sugetabletter; 800 mikrogram FENTANYLCITRAT 31/08/2016
Adenosin "Fresenius Kabi" injektionsvæske, opløsning, fyldt injektionssprøjte; 3 mg/ml ADENOSIN 20/07/2015
Adin frysetørret tablet; 120 mikrogram DESMOPRESSIN 13/10/2016
Adin frysetørret tablet; 240 mikrogram DESMOPRESSIN 13/10/2016
Adin frysetørret tablet; 60 mikrogram DESMOPRESSIN 13/10/2016
Adrenalin "Bradex" injektionsvæske, opløsning; 1 mg/ml ADRENALINTARTRAT 30/08/2017
Adrenalin "Stragen" injektionsvæske, opløsning, fyldt injektionssprøjte; 0,1 mg/ml ADRENALINTARTRAT 23/11/2015
Aduvanz kapsler, hårde; 30 mg Lisdexamfetamindimesilat 29/02/2016
Aduvanz kapsler, hårde; 50 mg Lisdexamfetamindimesilat 29/02/2016
Aduvanz kapsler, hårde; 70 mg Lisdexamfetamindimesilat 29/02/2016

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