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
Riastap pulver til injektions-/infusionsvæske, opløsning; 1 g Human fibrinogen 24/07/2019
Rigmin depotplastre; 13,3 mg/24 timer RIVASTIGMIN 29/04/2015
Riluzol "PMCS" filmovertrukne tabletter; 50 mg RILUZOL 19/06/2015
Rinometasone næsespray, suspension; 50 mikrogram/dosis Mometasonfuroat monohydrat 19/12/2013
Risedronatnatrium "Stada" filmovertrukne tabletter; 30 mg Risedronatnatriumhemipentahydrat 31/10/2014
Risedronatnatrium "Stada" filmovertrukne tabletter; 35 mg Risedronatnatriumhemipentahydrat 31/10/2014
Risedronatnatrium "Stada" filmovertrukne tabletter; 5 mg Risedronatnatriumhemipentahydrat 31/10/2014
Risepallin filmovertrukne tabletter; 30 mg Risedronatnatriumhemipentahydrat 11/06/2014
Risepallin filmovertrukne tabletter; 35 mg Risedronatnatriumhemipentahydrat 11/06/2014
Risepallin filmovertrukne tabletter; 5 mg Risedronatnatriumhemipentahydrat 11/06/2014
Risostad filmovertrukne tabletter; 35 mg Risedronatnatriumhemipentahydrat 17/09/2014
Risostad filmovertrukne tabletter; 5 mg Risedronatnatriumhemipentahydrat 17/09/2014
Risperdal filmovertrukne tabletter; 0,5 mg RISPERIDON 17/02/2020
Risperdal filmovertrukne tabletter; 1 mg RISPERIDON 17/02/2020
Risperdal oral opløsning; 1 mg/ml RISPERIDON 17/02/2020
Risperdal filmovertrukne tabletter; 2 mg RISPERIDON 17/02/2020
Risperdal filmovertrukne tabletter; 3 mg RISPERIDON 17/02/2020
Risperdal filmovertrukne tabletter; 4 mg RISPERIDON 17/02/2020
Risperdal Consta depotinjektionsvæske, pulver og solvens til suspension; 25 mg RISPERIDON 17/02/2020
Risperdal Consta depotinjektionsvæske, pulver og solvens til suspension; 37,5 mg RISPERIDON 17/02/2020
Risperdal Consta depotinjektionsvæske, pulver og solvens til suspension; 50 mg RISPERIDON 17/02/2020
Ritalin tabletter; 10 mg METHYLPHENIDATHYDROCHLORID 02/12/2015
Ritalin Uno kapsler med modificeret udløsning, hårde; 10 mg METHYLPHENIDATHYDROCHLORID 02/12/2015
Ritalin Uno kapsler med modificeret udløsning, hårde; 20 mg METHYLPHENIDATHYDROCHLORID 02/12/2015
Ritalin Uno kapsler med modificeret udløsning, hårde; 30 mg METHYLPHENIDATHYDROCHLORID 02/12/2015
Ritalin Uno kapsler med modificeret udløsning, hårde; 40 mg METHYLPHENIDATHYDROCHLORID 02/12/2015
Ritalin Uno kapsler med modificeret udløsning, hårde; 60 mg METHYLPHENIDATHYDROCHLORID 02/12/2015
Ritonavir "Accord" filmovertrukne tabletter; 100 mg RITONAVIR 06/12/2016
Rivadia filmovertrukne tabletter; 10 mg Rivaroxaban 09/01/2018
Rivadia filmovertrukne tabletter; 15 mg Rivaroxaban 09/01/2018
Rivadia filmovertrukne tabletter; 2,5 mg Rivaroxaban 09/01/2018
Rivadia filmovertrukne tabletter; 20 mg Rivaroxaban 09/01/2018
Rivaroxaban "Elpen" filmovertrukne tabletter; 10 mg Rivaroxaban 17/03/2020
Rivaroxaban "Elpen" filmovertrukne tabletter; 15 mg Rivaroxaban 17/03/2020
Rivaroxaban "Elpen" filmovertrukne tabletter; 2,5 mg Rivaroxaban 17/03/2020
Rivaroxaban "Elpen" filmovertrukne tabletter; 20 mg Rivaroxaban 17/03/2020
Rivaroxaban "Sandoz" filmovertrukne tabletter; 10 mg Rivaroxaban 01/09/2017
Rivaroxaban "Sandoz" filmovertrukne tabletter; 15 mg Rivaroxaban 01/09/2017
Rivaroxaban "Sandoz" filmovertrukne tabletter; 20 mg Rivaroxaban 01/09/2017
Rivastor depotplastre; 13,3 mg/24 timer RIVASTIGMIN 25/11/2019
Rivastor depotplastre; 4,6 mg/24 timer RIVASTIGMIN 03/04/2020
Rivastor depotplastre; 9,5 mg/24 timer RIVASTIGMIN 03/04/2020
Rivendra brusetabletter; 30 mg AMBROXOLHYDROCHLORID 08/07/2015
Rivendra brusetabletter; 60 mg AMBROXOLHYDROCHLORID 08/07/2015
Rivoxin filmovertrukne tabletter; 400 mg MOXIFLOXACINHYDROCHLORID 03/01/2018

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