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
Regiocit hæmofiltreringsvæske; 18/140 mmol/l NATRIUMCHLORID, Natriumcitrat 01/10/2014
Relafalk tabletter med modificeret udløsning; 200 mg Rifamycinnatrium 28/11/2018
Remodulin infusionsvæske, opløsning; 1 mg/ml Treprostinilnatrium 23/08/2019
Remodulin infusionsvæske, opløsning; 10 mg/ml Treprostinilnatrium 23/08/2019
Remodulin infusionsvæske, opløsning; 2,5 mg/ml Treprostinilnatrium 23/08/2019
Remodulin infusionsvæske, opløsning; 5 mg/ml Treprostinilnatrium 23/08/2019
Renocis radiofarmaceutisk præparationssæt; Succimer, Technetium (99m-Tc) succimer 06/12/2018
Renoscint MAG3 radiofarmaceutisk præparationssæt; 1 mg Betiatide 27/09/2017
Repevax injektionsvæske, suspension, fyldt injektionssprøjte; Bordetella pertussis, stamme 10536, filamentøs hæmagglutinin (FHA), Bordetella pertussis, stamme 10536, pertactin (PRN/69 kiloDalton ydermembranprotein), Bordetella pertussis, stamme 10536, toxoid, Clostridium tetani, stamme Boston II 60, toxoid, Poliovirus type 1, stamme Mahoney (inaktiveret), Poliovirus type 2, stamme MEF-1 (inaktiveret), Poliovirus type 3, stamme Saukett (inaktiveret) 29/05/2019
Revalenk filmovertrukne tabletter; 400 mg GLUCOSAMINSULFATKALIUMCHLORID 14/03/2019
Revitelle smeltetabletter; 10 mg Bilastin
Revitelle oral opløsning; 2,5 mg/ml Bilastin
Revitelle tabletter; 20 mg Bilastin 25/04/2016
Rewellfem vaginaltabletter; 10 mikrogram ESTRADIOLHEMIHYDRAT 02/07/2020
Rhesonativ injektionsvæske, opløsning; 625 IE/ml Anti-D immunglobulin, humant 10/01/2019

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