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
Ariadigne depottabletter; 150 mg QUETIAPIN FUMARAT 01/02/2017
Ariadigne depottabletter; 200 mg QUETIAPIN FUMARAT 01/02/2017
Ariadigne depottabletter; 300 mg QUETIAPIN FUMARAT 01/02/2017
Ariadigne depottabletter; 400 mg QUETIAPIN FUMARAT 01/02/2017
Ariadigne depottabletter; 50 mg QUETIAPIN FUMARAT 01/02/2017
Aripiprazol "Accord Healthcare" oral opløsning; 1 mg/ml Aripiprazol 13/09/2018
Aripiprazol "Accord Healthcare" tabletter; 10 mg Aripiprazol 13/09/2018
Aripiprazol "Accord Healthcare" smeltetabletter; 10 mg Aripiprazol 13/09/2018
Aripiprazol "Accord Healthcare" tabletter; 15 mg Aripiprazol 13/09/2018
Aripiprazol "Accord Healthcare" smeltetabletter; 15 mg Aripiprazol 13/09/2018
Aripiprazol "Accord Healthcare" tabletter; 30 mg Aripiprazol 13/09/2018
Aripiprazol "Accord Healthcare" smeltetabletter; 30 mg Aripiprazol 13/09/2018
Aripiprazol "Accord Healthcare" tabletter; 5 mg Aripiprazol 13/09/2018
Aripiprazol "Krka" tabletter; 5 mg Aripiprazol 26/11/2015
Aripiprazol "Stada" oral opløsning; 1 mg/ml Aripiprazol 14/12/2016
Aripiprazol "Stada" smeltetabletter; 10 mg Aripiprazol 25/05/2020
Aripiprazol "Stada" tabletter; 10 mg Aripiprazol 11/08/2015
Aripiprazol "Stada" smeltetabletter; 15 mg Aripiprazol 25/05/2020
Aripiprazol "Stada" tabletter; 15 mg Aripiprazol 11/08/2015
Aripiprazol "Stada" tabletter; 30 mg Aripiprazol 11/08/2015
Aripiprazol "Stada" tabletter; 5 mg Aripiprazol 11/08/2015
Aripiprazole "Medical Valley" tabletter; 10 mg Aripiprazol 13/12/2015
Aripiprazole "Medical Valley" tabletter; 15 mg Aripiprazol 13/12/2015
Aripiprazole "Medical Valley" tabletter; 30 mg Aripiprazol 13/12/2015
Aripiprazole "Medical Valley" tabletter; 5 mg Aripiprazol 13/12/2015
Aripiprazole "Orion" tabletter; 10 mg Aripiprazol 24/05/2019
Aripiprazole "Orion" tabletter; 15 mg Aripiprazol 24/05/2019
Aripiprazole "Orion" tabletter; 30 mg Aripiprazol 24/05/2019
Aripiprazole "Orion" tabletter; 5 mg Aripiprazol 24/05/2019
Aripiprazole "Teva" tabletter; 10 mg Aripiprazol 13/09/2018
Aripiprazole "Teva" tabletter; 15 mg Aripiprazol 13/09/2018
Aripiprazole "Teva" tabletter; 30 mg Aripiprazol 13/09/2018
Aripiprazole "Teva" tabletter; 5 mg Aripiprazol 13/09/2018
Aritavi enterokapsler, hårde; 30 mg DULOXETINHYDROCHLORID 09/06/2015
Aritavi enterokapsler, hårde; 60 mg DULOXETINHYDROCHLORID 09/06/2015
Arixobat oral opløsning; 500 mg/ml Natriumoxybat 16/09/2020
Aropilo SR depottabletter; 2 mg ROPINIROLHYDROCHLORID 17/03/2017
Aropilo SR depottabletter; 4 mg ROPINIROLHYDROCHLORID 17/03/2017
Aropilo SR depottabletter; 8 mg ROPINIROLHYDROCHLORID 17/03/2017
Arpoya tabletter; 10 mg Aripiprazol 07/11/2018
Arpoya smeltetabletter; 10 mg Aripiprazol 11/05/2015
Arpoya tabletter; 15 mg Aripiprazol 07/11/2018
Arpoya smeltetabletter; 15 mg Aripiprazol 11/05/2015
Arpoya tabletter; 30 mg Aripiprazol 07/11/2018
Arpoya smeltetabletter; 30 mg Aripiprazol 11/05/2015
Arpoya tabletter; 5 mg Aripiprazol 07/11/2018
Artiss vævsklæber; Aprotinin, CALCIUMCHLORIDDIHYDRAT, Human fibrinogen, Thrombin, humant 06/07/2017
Asacol tabletter med modificeret udløsning; 1600 mg MESALAZIN 18/01/2018
Ascorbinsyre "Pascoe" koncentrat til injektions-/infusionsvæske, opløsning; 150 mg/ml ASCORBINSYRE 05/08/2020
Asmanex Twisthaler inhalationspulver; 200 mikrogram/dosis Mometasonfuroat 03/08/2018
Asmanex Twisthaler inhalationspulver; 400 mikrogram/dosis Mometasonfuroat 29/08/2018
Asmoken tabletter; 1,5 mg Cytisin 27/09/2019
Atanto kapsler, hårde; 125 mg APREPITANT 14/12/2018
Atanto kapsler, hårde; 40 mg APREPITANT 14/12/2018
Atanto kapsler, hårde; 80 mg APREPITANT 14/12/2018
Atazanavir "Accord" kapsler, hårde; 200 mg ATAZANAVIRSULFAT 20/03/2019
Atazanavir "Accord" kapsler, hårde; 300 mg ATAZANAVIRSULFAT 20/03/2019
Atazanavir "Stada" kapsler, hårde; 200 mg ATAZANAVIRSULFAT 19/09/2018
Atazanavir "Stada" kapsler, hårde; 300 mg ATAZANAVIRSULFAT 19/09/2018
Atazanavir "Teva" kapsler, hårde; 150 mg ATAZANAVIRSULFAT 27/02/2017
Atazanavir "Teva" kapsler, hårde; 200 mg ATAZANAVIRSULFAT 27/02/2017
Atazanavir "Teva" kapsler, hårde; 300 mg ATAZANAVIRSULFAT 27/02/2017
Atenativ pulver og solvens til infusionsvæske, opløsning; 50 IE/ml Antitrombin III 16/08/2018
Atomoxetin "Glenmark" kapsler, hårde; 10 mg ATOMOXETINHYDROCHLORID 02/10/2018
Atomoxetin "Glenmark" kapsler, hårde; 100 mg ATOMOXETINHYDROCHLORID 02/10/2018
Atomoxetin "Glenmark" kapsler, hårde; 18 mg ATOMOXETINHYDROCHLORID 02/10/2018
Atomoxetin "Glenmark" kapsler, hårde; 25 mg ATOMOXETINHYDROCHLORID 02/10/2018
Atomoxetin "Glenmark" kapsler, hårde; 40 mg ATOMOXETINHYDROCHLORID 02/10/2018
Atomoxetin "Glenmark" kapsler, hårde; 60 mg ATOMOXETINHYDROCHLORID 02/10/2018
Atomoxetin "Glenmark" kapsler, hårde; 80 mg ATOMOXETINHYDROCHLORID 02/10/2018
Atomoxetin "Mylan" kapsler, hårde; 10 mg ATOMOXETINHYDROCHLORID 08/11/2017
Atomoxetin "Mylan" kapsler, hårde; 100 mg ATOMOXETINHYDROCHLORID 08/11/2017
Atomoxetin "Mylan" kapsler, hårde; 18 mg ATOMOXETINHYDROCHLORID 08/11/2017
Atomoxetin "Mylan" kapsler, hårde; 25 mg ATOMOXETINHYDROCHLORID 08/11/2017
Atomoxetin "Mylan" kapsler, hårde; 40 mg ATOMOXETINHYDROCHLORID 08/11/2017
Atomoxetin "Mylan" kapsler, hårde; 60 mg ATOMOXETINHYDROCHLORID 08/11/2017
Atomoxetin "Mylan" kapsler, hårde; 80 mg ATOMOXETINHYDROCHLORID 08/11/2017
Atomoxetin "Orion" kapsler, hårde; 10 mg ATOMOXETINHYDROCHLORID 24/03/2018
Atomoxetin "Orion" kapsler, hårde; 100 mg ATOMOXETINHYDROCHLORID 24/03/2018
Atomoxetin "Orion" kapsler, hårde; 18 mg ATOMOXETINHYDROCHLORID 24/03/2018
Atomoxetin "Orion" kapsler, hårde; 25 mg ATOMOXETINHYDROCHLORID 24/03/2018
Atomoxetin "Orion" kapsler, hårde; 40 mg ATOMOXETINHYDROCHLORID 24/03/2018
Atomoxetin "Orion" kapsler, hårde; 60 mg ATOMOXETINHYDROCHLORID 24/03/2018
Atomoxetin "Orion" kapsler, hårde; 80 mg ATOMOXETINHYDROCHLORID 24/03/2018
Atomoxetin "Teva" kapsler, hårde; 10 mg ATOMOXETINHYDROCHLORID 14/02/2016
Atomoxetin "Teva" kapsler, hårde; 100 mg ATOMOXETINHYDROCHLORID 14/02/2016
Atomoxetin "Teva" kapsler, hårde; 18 mg ATOMOXETINHYDROCHLORID 14/02/2016
Atomoxetin "Teva" kapsler, hårde; 25 mg ATOMOXETINHYDROCHLORID 14/02/2016
Atomoxetin "Teva" kapsler, hårde; 40 mg ATOMOXETINHYDROCHLORID 14/02/2016
Atomoxetin "Teva" kapsler, hårde; 60 mg ATOMOXETINHYDROCHLORID 14/02/2016
Atomoxetin "Teva" kapsler, hårde; 80 mg ATOMOXETINHYDROCHLORID 14/02/2016
Atomoxetine "Accord" kapsler, hårde; 10 mg ATOMOXETINHYDROCHLORID 16/10/2018
Atomoxetine "Accord" kapsler, hårde; 100 mg ATOMOXETINHYDROCHLORID 16/10/2018
Atomoxetine "Accord" kapsler, hårde; 18 mg ATOMOXETINHYDROCHLORID 16/10/2018
Atomoxetine "Accord" kapsler, hårde; 25 mg ATOMOXETINHYDROCHLORID 16/10/2018
Atomoxetine "Accord" kapsler, hårde; 40 mg ATOMOXETINHYDROCHLORID 16/10/2018
Atomoxetine "Accord" kapsler, hårde; 60 mg ATOMOXETINHYDROCHLORID 16/10/2018
Atomoxetine "Accord" kapsler, hårde; 80 mg ATOMOXETINHYDROCHLORID 16/10/2018
Atomoxetine "Stada" kapsler, hårde; 10 mg ATOMOXETINHYDROCHLORID 27/06/2018
Atomoxetine "Stada" kapsler, hårde; 100 mg ATOMOXETINHYDROCHLORID 27/06/2018
Atomoxetine "Stada" kapsler, hårde; 18 mg ATOMOXETINHYDROCHLORID 27/06/2018
Atomoxetine "Stada" kapsler, hårde; 25 mg ATOMOXETINHYDROCHLORID 27/06/2018
Atomoxetine "Stada" kapsler, hårde; 40 mg ATOMOXETINHYDROCHLORID 27/06/2018
Atomoxetine "Stada" kapsler, hårde; 60 mg ATOMOXETINHYDROCHLORID 27/06/2018
Atomoxetine "Stada" kapsler, hårde; 80 mg ATOMOXETINHYDROCHLORID 27/06/2018
Atorvastatin "1A Farma" filmovertrukne tabletter; 10 mg ATORVASTATINCALCIUM (trihydrat) 14/11/2016
Atorvastatin "1A Farma" filmovertrukne tabletter; 20 mg ATORVASTATINCALCIUM (trihydrat) 14/11/2016
Atorvastatin "1A Farma" filmovertrukne tabletter; 40 mg ATORVASTATINCALCIUM (trihydrat) 14/11/2016
Atorvastatin "1A Farma" filmovertrukne tabletter; 80 mg ATORVASTATINCALCIUM (trihydrat) 14/11/2016
Atorvastatin "Accord" filmovertrukne tabletter; 10 mg ATORVASTATINCALCIUM (trihydrat) 26/06/2017
Atorvastatin "Accord" filmovertrukne tabletter; 20 mg ATORVASTATINCALCIUM (trihydrat) 26/06/2017
Atorvastatin "Accord" filmovertrukne tabletter; 40 mg ATORVASTATINCALCIUM (trihydrat) 26/06/2017
Atorvastatin "Accord" filmovertrukne tabletter; 80 mg ATORVASTATINCALCIUM (trihydrat) 26/06/2017
Atorvastatin "Actavis" filmovertrukne tabletter; 10 mg Atorvastatincalcium 13/11/2018
Atorvastatin "Actavis" filmovertrukne tabletter; 20 mg Atorvastatincalcium 13/11/2018
Atorvastatin "Actavis" filmovertrukne tabletter; 40 mg Atorvastatincalcium 13/11/2018
Atorvastatin "Actavis" filmovertrukne tabletter; 80 mg ATORVASTATINCALCIUM (trihydrat) 13/11/2018
Atorvastatin "Aristo" filmovertrukne tabletter; 10 mg ATORVASTATINCALCIUM (trihydrat) 23/07/2020
Atorvastatin "Aristo" filmovertrukne tabletter; 20 mg ATORVASTATINCALCIUM (trihydrat) 23/07/2020
Atorvastatin "Aristo" filmovertrukne tabletter; 30 mg ATORVASTATINCALCIUM (trihydrat) 23/07/2020
Atorvastatin "Aristo" filmovertrukne tabletter; 40 mg ATORVASTATINCALCIUM (trihydrat) 23/07/2020
Atorvastatin "Aristo" filmovertrukne tabletter; 60 mg ATORVASTATINCALCIUM (trihydrat) 23/07/2020
Atorvastatin "Aristo" filmovertrukne tabletter; 80 mg ATORVASTATINCALCIUM (trihydrat) 23/07/2020
Atorvastatin "Krka d.d." filmovertrukne tabletter; 10 mg ATORVASTATINCALCIUM (trihydrat) 23/04/2019
Atorvastatin "Krka d.d." filmovertrukne tabletter; 20 mg ATORVASTATINCALCIUM (trihydrat) 23/04/2019
Atorvastatin "Krka d.d." filmovertrukne tabletter; 40 mg ATORVASTATINCALCIUM (trihydrat) 23/04/2019
Atorvastatin "Krka d.d." filmovertrukne tabletter; 80 mg ATORVASTATINCALCIUM (trihydrat) 23/04/2019
Atorvastatin "Xiromed" filmovertrukne tabletter; 10 mg ATORVASTATINCALCIUM (trihydrat) 14/02/2017
Atorvastatin "Xiromed" filmovertrukne tabletter; 20 mg ATORVASTATINCALCIUM (trihydrat) 14/02/2017
Atorvastatin "Xiromed" filmovertrukne tabletter; 40 mg ATORVASTATINCALCIUM (trihydrat) 14/02/2017
Atorvastatin "Xiromed" filmovertrukne tabletter; 80 mg ATORVASTATINCALCIUM (trihydrat) 14/02/2017
Atosiban "Accord" koncentrat til infusionsvæske, opløsning; 37,5 mg/5 ml ATOSIBAN 22/07/2015
Atosiban "Accord" injektionsvæske, opløsning i fyldt injektionssprøjte; 6,75 mg/0,9 ml ATOSIBANACETAT 06/06/2018
Atosiban "EVER Pharma" koncentrat til infusionsvæske, opløsning; 37,5 mg/5 ml ATOSIBAN 01/09/2016
Atosiban "EVER Pharma" injektionsvæske, opløsning; 6,75 mg/0,9 ml ATOSIBAN 01/09/2016
Atosiban "EVER Pharma" koncentrat til infusionsvæske, opløsning; 75 mg/10 ml ATOSIBAN 01/09/2016
Atovaquon/Proguanilhydrochlorid "Glenmark" filmovertrukne tabletter; 250+100 mg ATOVAQUON, PROGUANILHYDROCHLORID 23/07/2013
Atovaquone "Glenmark" oral suspension; 150 mg/ ml ATOVAQUON 16/08/2019
Atozet filmovertrukne tabletter; 10+10 mg ATORVASTATINCALCIUM (trihydrat), EZETIMIB 10/07/2016
Atozet filmovertrukne tabletter; 10+20 mg ATORVASTATINCALCIUM (trihydrat), EZETIMIB 10/07/2016
Atozet filmovertrukne tabletter; 10+40 mg ATORVASTATINCALCIUM (trihydrat), EZETIMIB 10/07/2016
Atozet filmovertrukne tabletter; 10+80 mg ATORVASTATINCALCIUM (trihydrat), EZETIMIB 10/07/2016
Audalis filmovertrukne tabletter; 10 mg ATOMOXETINHYDROCHLORID 01/11/2018
Audalis filmovertrukne tabletter; 100 mg ATOMOXETINHYDROCHLORID 01/11/2018
Audalis filmovertrukne tabletter; 18 mg ATOMOXETINHYDROCHLORID 01/11/2018
Audalis filmovertrukne tabletter; 25 mg ATOMOXETINHYDROCHLORID 01/11/2018
Audalis filmovertrukne tabletter; 40 mg ATOMOXETINHYDROCHLORID 01/11/2018
Audalis filmovertrukne tabletter; 60 mg ATOMOXETINHYDROCHLORID 01/11/2018
Audalis filmovertrukne tabletter; 80 mg ATOMOXETINHYDROCHLORID 01/11/2018

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