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 "Accord" | filmovertrukne tabletter; | 300 mg | Abacavir | 04/05/2020 |
Abacavir/Lamivudin "Medical Valley" | filmovertrukne tabletter; | 600+300 mg | Abacavirsulfat, LAMIVUDIN | 21/01/2019 |
Abacavir/Lamivudin "Mylan Pharma" | filmovertrukne tabletter; | 600+300 mg | Abacavirsulfat, LAMIVUDIN | 02/05/2019 |
Abacavir/Lamivudin "Mylan" | filmovertrukne tabletter; | 600+300 mg | Abacavirhydrochlorid, LAMIVUDIN | 18/04/2016 |
Abacavir/Lamivudine "Accord" | filmovertrukne tabletter; | 600+300 mg | Abacavir, LAMIVUDIN | 29/09/2017 |
Abacavir/Lamivudine "Glenmark" | filmovertrukne tabletter; | 600+300 mg | Abacavirhydrochlorid, LAMIVUDIN | 13/04/2018 |
Abacavir/Lamivudine "Stada" | filmovertrukne tabletter; | 600+300 mg | Abacavir, LAMIVUDIN | 01/03/2016 |
Abacavir/Lamivudine "Teva" | filmovertrukne tabletter; | 600+300 mg | Abacavirhydrochlorid, LAMIVUDIN | 01/08/2019 |
Abacavir/Lamivudine "Zentiva" | filmovertrukne tabletter; | 600+300 mg | Abacavirsulfat, LAMIVUDIN | 16/05/2020 |
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 |
Accusol 35 | hæmodiafiltreringsvæske, opløsning; | CALCIUMCHLORIDDIHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT | 03/04/2020 | |
Accusol 35 Kalium 2 mmol/l | hæmodiafiltreringsvæske, opløsning; | 2 mmol/l | CALCIUMCHLORIDDIHYDRAT, Glucose, vandfri, GLUCOSEMONOHYDRAT, KALIUMCHLORID, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT | 03/04/2020 |
Accusol 35 Kalium 4 mmol/l | hæmodiafiltreringsvæske, opløsning; | 4 mmol/l | CALCIUMCHLORIDDIHYDRAT, Glucose, vandfri, GLUCOSEMONOHYDRAT, KALIUMCHLORID, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT | 03/04/2020 |
Accutin | kapsler, bløde; | 10 mg | Isotretinoin | 29/01/2019 |
Accutin | kapsler, bløde; | 20 mg | Isotretinoin | 29/01/2019 |
Acetylsalicylsyre "Teva" | tabletter; | 150 mg | ACETYLSALICYLSYRE | 20/09/2016 |
Acetylsalicylsyre "Teva" | tabletter; | 75 mg | ACETYLSALICYLSYRE | 20/09/2016 |
Aciclovir "Accord" | koncentrat til infusionsvæske, opløsning; | 25 mg/ml | ACICLOVIR | 19/03/2020 |
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 i fyldt injektionssprøjte; | 3 mg/ml | ADENOSIN | 20/07/2015 |
Aderolio | tabletter; | 0,25 mg | Everolimus | 06/11/2017 |
Aderolio | tabletter; | 0,5 mg | Everolimus | 06/11/2017 |
Aderolio | tabletter; | 0,75 mg | Everolimus | 06/11/2017 |
Aderolio | tabletter; | 1 mg | Everolimus | 06/11/2017 |
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 "Aguettant" | injektionsvæske, opløsning i fyldt injektionssprøjte; | 1 mg/ml | ADRENALINTARTRAT | 27/03/2020 |
Adrenalin "Bradex" | injektionsvæske, opløsning; | 1 mg/ml | ADRENALINTARTRAT | 30/08/2017 |
Adrenalin "Ethypharm" | injektionsvæske, opløsning; | 1 mg/ml | ADRENALINTARTRAT | 01/03/2019 |
Adrenalin "Stragen" | injektionsvæske, opløsning i 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 |