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
Pabal injektionsvæske, opløsning; 100 mikrogram/ml CARBETOCIN 02/10/2019
Padviram filmovertrukne tabletter; 600+200+245 mg EFAVIRENZ, EMTRICITABIN, Tenofovirdisoproxil 09/08/2017
Paliperidon "Krka" depottabletter; 3 mg Paliperidon 22/03/2018
Paliperidon "Krka" depottabletter; 6 mg Paliperidon 22/03/2018
Paliperidon "Krka" depottabletter; 9 mg Paliperidon 22/03/2018
Paliperidon "Teva" depotinjektionsvæske, suspension; 100 mg Paliperidonpalmitat 17/07/2019
Paliperidon "Teva" depotinjektionsvæske, suspension; 150 mg Paliperidonpalmitat 17/07/2019
Paliperidon "Teva" depotinjektionsvæske, suspension; 25 mg Paliperidonpalmitat 17/07/2019
Paliperidon "Teva" depotinjektionsvæske, suspension; 50 mg Paliperidonpalmitat 17/07/2019
Paliperidon "Teva" depotinjektionsvæske, suspension; 75 mg Paliperidonpalmitat 17/07/2019
Palonosetron "Fresenius Kabi" injektionsvæske, opløsning; 50 mikrogram/ml PALONOSETRONHYDROCHLORID 26/05/2016
Palonosetron "Fresenius Kabi" injektionsvæske, opløsning i fyldt injektionssprøjte; 50 mikrogram/ml PALONOSETRONHYDROCHLORID 26/05/2016
Palonosetron "Macure" injektionsvæske, opløsning; 50 mikrogram/ml PALONOSETRONHYDROCHLORID 20/04/2016
Palonosetron "Reig Jofre" injektionsvæske, opløsning; 50 mikrogram/ml PALONOSETRONHYDROCHLORID 11/04/2016
Palonosetron "Stada" injektionsvæske, opløsning; 50 mikrogram/ml PALONOSETRONHYDROCHLORID 18/05/2016
Palonosetronhydrochlorid "Qilu" injektionsvæske, opløsning; 50 mikrogram/ml PALONOSETRONHYDROCHLORID 27/05/2016
Pamidronat "Hexal" koncentrat til infusionsvæske, opløsning; 15 mg/ml PAMIDRONSYRE 12/02/2016
Pamidronatdinatrium "Pfizer" koncentrat til infusionsvæske, opløsning; 3 mg/ml Pamidronsyre, vandfrit 27/04/2016
Pamidronatdinatrium "Pfizer" koncentrat til infusionsvæske, opløsning; 6 mg/ml Pamidronsyre, vandfrit 27/04/2016
Pamidronatdinatrium "Pfizer" koncentrat til infusionsvæske, opløsning; 9 mg/ml Pamidronsyre, vandfrit 27/04/2016
Pamorelin depotinjektionsvæske, pulver og solvens til suspension; 3,75 mg TRIPTORELIN 25/07/2018
Pankaine Spinal tung injektionsvæske, opløsning; 5 mg/ml BUPIVACAINHYDROCHLORID, VANDFRI 20/03/2019
Panodil Extra filmovertrukne tabletter; 500+65 mg Caffein, PARACETAMOL 21/03/2018
Pantoprazol "Accord" pulver til injektionsvæske, opløsning; 40 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 07/10/2014
Pantoprazol "Aristo" pulver til injektionsvæske, opløsning; 40 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 16/08/2016
Pantoprazol "Aurobindo" enterotabletter; 20 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 17/06/2014
Pantoprazol "Aurobindo" enterotabletter; 40 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 17/06/2014
Pantoprazol "Mylan" enterotabletter; 20 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 29/08/2018
Pantoprazol "Mylan" enterotabletter; 40 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 29/08/2018
Pantoprazol "Orion" enterotabletter; 20 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 20/12/2017
Pantoprazol "Orion" enterotabletter; 40 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 20/12/2017
Pantoprazol "Reig Jofre" pulver til injektionsvæske, opløsning; 40 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 16/11/2016
Pantoprazol "SUN" pulver til injektionsvæske, opløsning; 40 mg PANTOPRAZOLNATRIUMSESQUIHYDRAT 22/12/2014
Panzyga infusionsvæske, opløsning; 100 mg/ml Normalt immunglobulin, humant 04/02/2016
Paracetamol "Accord" tabletter; 500 mg PARACETAMOL 01/11/2015
Paracetamol "B. Braun" infusionsvæske, opløsning; 10 mg/ml PARACETAMOL 22/05/2015
Paracetamol "Mylan" tabletter; 1000 mg PARACETAMOL 19/06/2019
Paracetamol "Mylan" tabletter; 500 mg PARACETAMOL 19/06/2019
Paracetamol "Nutra Essential" tabletter; 500 mg PARACETAMOL 17/01/2018
Paracetamol "Panpharma" infusionsvæske, opløsning; 10 mg/ml PARACETAMOL 12/11/2018
Paracoff filmovertrukne tabletter; 500+65 mg Caffein, PARACETAMOL 23/11/2017
Paradol filmovertrukne tabletter; 1000 mg PARACETAMOL 14/03/2016
Paradol filmovertrukne tabletter; 500 mg PARACETAMOL 14/03/2016
Paraseu tabletter; 500+30 mg PARACETAMOL, PSEUDOEPHEDRINHYDROCHLORID 23/11/2017
Paroex mundskyllevæske; 1,2 mg/ml Chlorhexidindigluconat-opløsning (20%) 24/07/2017
Paroxetin "Aurobindo" filmovertrukne tabletter; 20 mg Paroxetinhydrochloridhemihydrat 18/11/2013
Paroxetin "Aurobindo" filmovertrukne tabletter; 30 mg Paroxetinhydrochloridhemihydrat 18/11/2013

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