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
Pramipexol "neuraxpharm" tabletter; 0,088 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 14/06/2018
Pramipexol "neuraxpharm" tabletter; 0,18 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 14/06/2018
Pramipexol "neuraxpharm" tabletter; 0,35 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 14/06/2018
Pramipexol "neuraxpharm" tabletter; 0,7 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 14/06/2018
Pramipexol "neuraxpharm" tabletter; 1,1 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 14/06/2018
Pramipexol "Stada" depottabletter; 0,26 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 17/05/2019
Pramipexol "Stada" depottabletter; 0,52 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 17/05/2019
Pramipexol "Stada" depottabletter; 1,05 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 17/05/2019
Pramipexol "Stada" depottabletter; 1,57 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 17/05/2019
Pramipexol "Stada" depottabletter; 2,1 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 17/05/2019
Pramipexol "Stada" depottabletter; 2,62 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 17/05/2019
Pramipexol "Stada" depottabletter; 3,15 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 17/05/2019
Pramipexol "Teva Pharma" depottabletter; 0,26 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 01/12/2014
Pramipexol "Teva Pharma" depottabletter; 0,52 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 01/12/2014
Pramipexol "Teva Pharma" depottabletter; 1,05 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 01/12/2014
Pramipexol "Teva Pharma" depottabletter; 1,57 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 01/12/2014
Pramipexol "Teva Pharma" depottabletter; 2,1 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 01/12/2014
Pramipexol "Teva Pharma" depottabletter; 2,62 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 01/12/2014
Pramipexol "Teva Pharma" depottabletter; 3,15 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 01/12/2014
Pramipexole "Orion" depottabletter; 0,26 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 12/03/2020
Pramipexole "Orion" depottabletter; 0,52 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 12/03/2020
Pramipexole "Orion" depottabletter; 1,05 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 12/03/2020
Pramipexole "Orion" depottabletter; 1,57 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 12/03/2020
Pramipexole "Orion" depottabletter; 2,1 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 12/03/2020
Pramipexole "Orion" depottabletter; 2,62 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 12/03/2020
Pramipexole "Orion" depottabletter; 3,15 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 12/03/2020
Pramipexole "Sandoz" depottabletter; 0,26 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 05/09/2018
Pramipexole "Sandoz" depottabletter; 0,52 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 05/09/2018
Pramipexole "Sandoz" depottabletter; 1,05 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 05/09/2018
Pramipexole "Sandoz" depottabletter; 1,57 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 05/09/2018
Pramipexole "Sandoz" depottabletter; 2,1 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 05/09/2018
Pramipexole "Sandoz" depottabletter; 2,62 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 05/09/2018
Pramipexole "Sandoz" depottabletter; 3,15 mg PRAMIPEXOLDIHYDROCHLORIDMONOHYDRAT 05/09/2018
Prasugrel "Krka" filmovertrukne tabletter; 10 mg Prasugrel 26/07/2018
Prasugrel "Krka" filmovertrukne tabletter; 5 mg Prasugrel 26/07/2018
Prednisolon "Actavis" tabletter; 10 mg PREDNISOLON 16/02/2016
Prednisolon "Actavis" tabletter; 2,5 mg PREDNISOLON 16/02/2016
Prednisolon "Actavis" tabletter; 20 mg PREDNISOLON 16/02/2016
Prednisolon "Actavis" tabletter; 25 mg PREDNISOLON 16/02/2016
Prednisolon "Actavis" tabletter; 30 mg PREDNISOLON 16/02/2016
Prednisolon "Actavis" tabletter; 5 mg PREDNISOLON 16/02/2016
Prednisolon "Unimedic" rektalvæske, opløsning; 31,25 mg PREDNISOLONNATRIUMPHOSPHAT 04/02/2020
Pregabalin "Aristo" kapsler, hårde; 100 mg Pregabalin 23/11/2019
Pregabalin "Aristo" kapsler, hårde; 150 mg Pregabalin 23/11/2019
Pregabalin "Aristo" kapsler, hårde; 200 mg Pregabalin 23/11/2019
Pregabalin "Aristo" kapsler, hårde; 225 mg Pregabalin 23/11/2019
Pregabalin "Aristo" kapsler, hårde; 25 mg Pregabalin 23/11/2019
Pregabalin "Aristo" kapsler, hårde; 300 mg Pregabalin 23/11/2019
Pregabalin "Aristo" kapsler, hårde; 50 mg Pregabalin 23/11/2019
Pregabalin "Aristo" kapsler, hårde; 75 mg Pregabalin 23/11/2019
Pregabalin "EQL Pharma" kapsler, hårde; 100 mg Pregabalin 16/10/2018
Pregabalin "EQL Pharma" kapsler, hårde; 150 mg Pregabalin 16/10/2018
Pregabalin "EQL Pharma" kapsler, hårde; 200 mg Pregabalin 16/10/2018
Pregabalin "EQL Pharma" kapsler, hårde; 225 mg Pregabalin 16/10/2018
Pregabalin "EQL Pharma" kapsler, hårde; 25 mg Pregabalin 16/10/2018
Pregabalin "EQL Pharma" kapsler, hårde; 300 mg Pregabalin 16/10/2018
Pregabalin "EQL Pharma" kapsler, hårde; 50 mg Pregabalin 16/10/2018
Pregabalin "EQL Pharma" kapsler, hårde; 75 mg Pregabalin 16/10/2018
Pregabalin "Krka" kapsler, hårde; 100 mg Pregabalin 15/12/2014
Pregabalin "Krka" kapsler, hårde; 150 mg Pregabalin 15/12/2014
Pregabalin "Krka" kapsler, hårde; 200 mg Pregabalin 15/12/2014
Pregabalin "Krka" kapsler, hårde; 225 mg Pregabalin 15/12/2014
Pregabalin "Krka" kapsler, hårde; 25 mg Pregabalin 15/12/2014
Pregabalin "Krka" kapsler, hårde; 300 mg Pregabalin 15/12/2014
Pregabalin "Krka" kapsler, hårde; 50 mg Pregabalin 15/12/2014
Pregabalin "Krka" kapsler, hårde; 75 mg Pregabalin 15/12/2014
Pregabalin "Laurus" kapsler, hårde; 100 mg Pregabalin 06/03/2019
Pregabalin "Laurus" kapsler, hårde; 150 mg Pregabalin 06/03/2019
Pregabalin "Laurus" kapsler, hårde; 200 mg Pregabalin 06/03/2019
Pregabalin "Laurus" kapsler, hårde; 225 mg Pregabalin 06/03/2019
Pregabalin "Laurus" kapsler, hårde; 25 mg Pregabalin 06/03/2019
Pregabalin "Laurus" kapsler, hårde; 300 mg Pregabalin 06/03/2019
Pregabalin "Laurus" kapsler, hårde; 50 mg Pregabalin 06/03/2019
Pregabalin "Laurus" kapsler, hårde; 75 mg Pregabalin 06/03/2019
Pregabalin "Medical Valley" kapsler, hårde; 100 mg Pregabalin 24/02/2016
Pregabalin "Medical Valley" kapsler, hårde; 150 mg Pregabalin 24/02/2016
Pregabalin "Medical Valley" kapsler, hårde; 200 mg Pregabalin 24/02/2016
Pregabalin "Medical Valley" kapsler, hårde; 25 mg Pregabalin 24/02/2016
Pregabalin "Medical Valley" kapsler, hårde; 300 mg Pregabalin 24/02/2016
Pregabalin "Medical Valley" kapsler, hårde; 50 mg Pregabalin 24/02/2016
Pregabalin "Medical Valley" kapsler, hårde; 75 mg Pregabalin 24/02/2016
Pregabalin "Orion" kapsler, hårde; 100 mg Pregabalin 13/06/2019
Pregabalin "Orion" kapsler, hårde; 150 mg Pregabalin 13/06/2019
Pregabalin "Orion" kapsler, hårde; 225 mg Pregabalin 13/06/2019
Pregabalin "Orion" kapsler, hårde; 25 mg Pregabalin 13/06/2019
Pregabalin "Orion" kapsler, hårde; 300 mg Pregabalin 13/06/2019
Pregabalin "Orion" kapsler, hårde; 50 mg Pregabalin 13/06/2019
Pregabalin "Orion" kapsler, hårde; 75 mg Pregabalin 13/06/2019
Pregabalin "Teva" kapsler, hårde; 100 mg Pregabalin 09/06/2016
Pregabalin "Teva" kapsler, hårde; 150 mg Pregabalin 09/06/2016
Pregabalin "Teva" kapsler, hårde; 200 mg Pregabalin 09/06/2016
Pregabalin "Teva" kapsler, hårde; 225 mg Pregabalin 09/06/2016
Pregabalin "Teva" kapsler, hårde; 25 mg Pregabalin 09/06/2016
Pregabalin "Teva" kapsler, hårde; 300 mg Pregabalin 09/06/2016
Pregabalin "Teva" kapsler, hårde; 50 mg Pregabalin 09/06/2016
Pregabalin "Teva" kapsler, hårde; 75 mg Pregabalin 09/06/2016
Pregafra kapsler, hårde; 100 mg Pregabalin 25/08/2015
Pregafra kapsler, hårde; 150 mg Pregabalin 25/08/2015
Pregafra kapsler, hårde; 200 mg Pregabalin 25/08/2015
Pregafra kapsler, hårde; 225 mg Pregabalin 25/08/2015
Pregafra kapsler, hårde; 25 mg Pregabalin 25/08/2015
Pregafra kapsler, hårde; 300 mg Pregabalin 25/08/2015
Pregafra kapsler, hårde; 50 mg Pregabalin 25/08/2015
Pregafra kapsler, hårde; 75 mg Pregabalin 25/08/2015
Prelynca kapsler, hårde; 100 mg Pregabalin 13/05/2015
Prelynca kapsler, hårde; 150 mg Pregabalin 13/05/2015
Prelynca kapsler, hårde; 200 mg Pregabalin 13/05/2015
Prelynca kapsler, hårde; 225 mg Pregabalin 13/05/2015
Prelynca kapsler, hårde; 25 mg Pregabalin 13/05/2015
Prelynca kapsler, hårde; 300 mg Pregabalin 13/05/2015
Prelynca kapsler, hårde; 50 mg Pregabalin 13/05/2015
Prelynca kapsler, hårde; 75 mg Pregabalin 13/05/2015
Prenoxad injektionsvæske, opløsning i fyldt injektionssprøjte; 0,9 mg/ml NALOXONHYDROCHLORID (vandfrit) 12/12/2019
Priminova filmovertrukne tabletter; 800 mg Phenoxymethylpenicillinkalium 16/08/2019
Primovist injektionsvæske, opløsning i fyldt injektionssprøjte; 0,25 mmol/ml Dinatriumgadoxetat 18/05/2020
Primovist injektionsvæske, opløsning; 0,25 mmol/ml Dinatriumgadoxetat 18/05/2020
Primve pulver til oral suspension; 100 mg/ml Phenoxymethylpenicillinkalium 08/09/2016
Primve pulver til oral suspension; 50 mg/ml Phenoxymethylpenicillinkalium 08/09/2016
Priorix-Tetra pulver og solvens til injektionsvæske, opløsning, fyldt injektionssprøjte; Fåresygevirus, stamme RIT 4385 - afledt af Jeryl Lynn (levende, svækket), Mæslingevirus, stamme Schwarz (levende, svækket), Røde hunde virus, stamme Wistar RA 27/3 (levende, svækket), Varicella zoster virus, st. Oka (levende, svækket) 20/11/2019
Proasa tabletter; 75 mg ACETYLSALICYLSYRE 12/04/2019
Procivni injektionsvæske, opløsning; 25 mikrogram+1 mg Aviptadil, Phentolaminmesilat 23/07/2013
Procivni injektionsvæske, opløsning; 25 mikrogram+2 mg Aviptadil, Phentolaminmesilat 23/07/2013
Prograf kapsler, hårde; 0,5 mg TACROLIMUS (vandfrit) 06/02/2017
Prograf kapsler, hårde; 1 mg TACROLIMUS (vandfrit) 06/02/2017
Prograf kapsler, hårde; 5 mg TACROLIMUS (vandfrit) 06/02/2017
Prograf koncentrat til infusionsvæske, opløsning; 5 mg/ml TACROLIMUS (vandfrit) 06/02/2017
Prometazin "Actavis" filmovertrukne tabletter; 25 mg PROMETHAZINHYDROCHLORID 05/07/2016
Prothromplex pulver og solvens til injektionsvæske, opløsning; 600 IE Koagulationsfaktor II, humant, Koagulationsfaktor IX, humant, Koagulationsfaktor VII, humant, Koagulationsfaktor X, humant, PROTEIN C, human 18/06/2014
Provocholine pulver til opløsning til nebulisator; 100 mg Methacholinchlorid 22/04/2020
Prucalopride "Orifarm" filmovertrukne tabletter; 1 mg prucalopridsuccinat 27/11/2019
Pulmocis radiofarmaceutisk præparationssæt; 2 mg ALBUMIN, HUMAN 06/04/2020
Purimmun tabletter; 50 mg MERCAPTOPURIN 15/03/2018

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.


...