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
Rocasium filmovertrukne tabletter; 10 mg Rosuvastatin calcium 27/07/2018
Rocasium filmovertrukne tabletter; 20 mg Rosuvastatin calcium 27/07/2018
Rocasium filmovertrukne tabletter; 40 mg Rosuvastatin calcium 12/07/2016
Rocasium filmovertrukne tabletter; 5 mg Rosuvastatin calcium 27/07/2018
Rocephalin pulver til infusionsvæske, opløsning; 2 g Ceftriaxonnatrium 08/11/2019
Rocephalin IV pulver og solvens til injektionsvæske, opløsning; 1 g Ceftriaxonnatrium 08/11/2019
Rocuronium "Hameln" injektions-/infusionsvæske, opløsning; 10 mg/ml ROCURONIUMBROMID 30/12/2017
Ropivacaine "BioQ" infusionsvæske, opløsning i administrationssystem; 2 mg/ml Ropivacainhydrochloridmonohydrat 08/11/2017
Rosucalva filmovertrukne tabletter; 10 mg Rosuvastatin calcium 27/07/2018
Rosucalva filmovertrukne tabletter; 20 mg Rosuvastatin calcium 27/07/2018
Rosucalva filmovertrukne tabletter; 40 mg Rosuvastatin calcium 27/07/2018
Rosucalva filmovertrukne tabletter; 5 mg Rosuvastatin calcium 27/07/2018
Rosudia filmovertrukne tabletter; 10 mg Rosuvastatin calcium 21/11/2016
Rosudia filmovertrukne tabletter; 15 mg Rosuvastatin calcium 21/11/2016
Rosudia filmovertrukne tabletter; 20 mg Rosuvastatin calcium 21/11/2016
Rosudia filmovertrukne tabletter; 30 mg Rosuvastatin calcium 21/11/2016
Rosudia filmovertrukne tabletter; 40 mg Rosuvastatin calcium 21/11/2016
Rosudia filmovertrukne tabletter; 5 mg Rosuvastatin calcium 21/11/2016
Rosufy filmovertrukne tabletter; 20 mg Rosuvastatin calcium 04/05/2017
Rosufy filmovertrukne tabletter; 40 mg Rosuvastatin calcium 04/05/2017
Rosufy filmovertrukne tabletter; 5 mg Rosuvastatin calcium 04/05/2017
Rosunogra filmovertrukne tabletter; 10 mg Rosuvastatin calcium 04/05/2017
Rosunogra filmovertrukne tabletter; 20 mg Rosuvastatin calcium 04/05/2017
Rosunogra filmovertrukne tabletter; 40 mg Rosuvastatin calcium 04/05/2017
Rosunogra filmovertrukne tabletter; 5 mg Rosuvastatin calcium 04/05/2017
Rosuteva filmovertrukne tabletter; 10 mg Rosuvastatin calcium 27/07/2018
Rosuteva filmovertrukne tabletter; 20 mg Rosuvastatin calcium 27/07/2018
Rosuteva filmovertrukne tabletter; 40 mg Rosuvastatin calcium 27/07/2018
Rosuteva filmovertrukne tabletter; 5 mg Rosuvastatin calcium 27/07/2018
Rosuvastatin "Accord" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 16/07/2015
Rosuvastatin "Accord" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 16/07/2015
Rosuvastatin "Accord" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 16/07/2015
Rosuvastatin "Accord" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 16/07/2015
Rosuvastatin "Aristo" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "Aristo" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "Aristo" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "Aristo" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "Centrient" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "Centrient" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "Centrient" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "DOC" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "DOC" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "DOC" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "DOC" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 20/04/2017
Rosuvastatin "Glenmark" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 12/01/2017
Rosuvastatin "Glenmark" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 12/01/2017
Rosuvastatin "Glenmark" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 12/01/2017
Rosuvastatin "Glenmark" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 12/01/2017
Rosuvastatin "Krka d.d." filmovertrukne tabletter; 10 mg Rosuvastatin calcium 21/11/2016
Rosuvastatin "Krka d.d." filmovertrukne tabletter; 15 mg Rosuvastatin calcium 21/11/2016
Rosuvastatin "Krka d.d." filmovertrukne tabletter; 20 mg Rosuvastatin calcium 21/11/2016
Rosuvastatin "Krka d.d." filmovertrukne tabletter; 30 mg Rosuvastatin calcium 21/11/2016
Rosuvastatin "Krka d.d." filmovertrukne tabletter; 40 mg Rosuvastatin calcium 21/11/2016
Rosuvastatin "Krka d.d." filmovertrukne tabletter; 5 mg Rosuvastatin calcium 21/11/2016
Rosuvastatin "Laboratorios Liconsa" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 14/06/2018
Rosuvastatin "Laboratorios Liconsa" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 14/06/2018
Rosuvastatin "Laboratorios Liconsa" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 14/06/2018
Rosuvastatin "Laboratorios Liconsa" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 14/06/2018
Rosuvastatin "Liconsa" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 05/02/2020
Rosuvastatin "Liconsa" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 05/02/2020
Rosuvastatin "Liconsa" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 05/02/2020
Rosuvastatin "Liconsa" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 05/02/2020
Rosuvastatin "Medical Valley" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 19/02/2020
Rosuvastatin "Medical Valley" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 19/02/2020
Rosuvastatin "Medical Valley" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 19/02/2020
Rosuvastatin "Medical Valley" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 19/02/2020
Rosuvastatin "Mylan" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 09/11/2018
Rosuvastatin "Mylan" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 09/11/2018
Rosuvastatin "Mylan" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 09/11/2018
Rosuvastatin "Mylan" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 09/11/2018
Rosuvastatin "Orion" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 20/10/2016
Rosuvastatin "Orion" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 20/10/2016
Rosuvastatin "Orion" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 20/10/2016
Rosuvastatin "Orion" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 20/10/2016
Rosuvastatin "Stada" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 21/01/2015
Rosuvastatin "Stada" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 21/01/2015
Rosuvastatin "Stada" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 21/01/2015
Rosuvastatin "Stada" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 21/01/2015
Rosuvastatin "Teva" filmovertrukne tabletter; 10 mg Rosuvastatin calcium 05/02/2020
Rosuvastatin "Teva" filmovertrukne tabletter; 20 mg Rosuvastatin calcium 05/02/2020
Rosuvastatin "Teva" filmovertrukne tabletter; 40 mg Rosuvastatin calcium 05/02/2020
Rosuvastatin "Teva" filmovertrukne tabletter; 5 mg Rosuvastatin calcium 05/02/2020
Rosuvavel filmovertrukne tabletter; 10 mg Rosuvastatin calcium 04/05/2017
Rosuvavel filmovertrukne tabletter; 20 mg Rosuvastatin calcium 04/05/2017
Rosuvavel filmovertrukne tabletter; 40 mg Rosuvastatin calcium 04/05/2017
Rosuvavel filmovertrukne tabletter; 5 mg Rosuvastatin calcium 04/05/2017
Rosuvex filmovertrukne tabletter; 10 mg Rosuvastatin calcium 04/05/2017
Rosuvex filmovertrukne tabletter; 20 mg Rosuvastatin calcium 04/05/2017
Rosuvex filmovertrukne tabletter; 40 mg Rosuvastatin calcium 04/05/2017
Rosuvex filmovertrukne tabletter; 5 mg Rosuvastatin calcium 04/05/2017
Rosval filmovertrukne tabletter; 10 mg Rosuvastatin calcium 19/02/2020
Rosval filmovertrukne tabletter; 20 mg Rosuvastatin calcium 19/02/2020
Rosval filmovertrukne tabletter; 40 mg Rosuvastatin calcium 14/06/2018
Rosval filmovertrukne tabletter; 5 mg Rosuvastatin calcium 19/02/2020
Rovatina filmovertrukne tabletter; 10 mg Rosuvastatin calcium 17/11/2016
Rovatina filmovertrukne tabletter; 20 mg Rosuvastatin calcium 17/11/2016
Rovatina filmovertrukne tabletter; 40 mg Rosuvastatin calcium 17/11/2016
Rovatina filmovertrukne tabletter; 5 mg Rosuvastatin calcium 17/11/2016
Roxithromycin "Medical Valley" filmovertrukne tabletter; 150 mg ROXITHROMYCIN 04/06/2020

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