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
Labetalol "S.A.L.F." injektions-/infusionsvæske, opløsning; 5 mg/ml LABETALOLHYDROCHLORID 02/11/2016
Lacidipin "Double-E Pharma" filmovertrukne tabletter; 2 mg LACIDIPIN 23/04/2015
Lacidipin "Double-E Pharma" filmovertrukne tabletter; 4 mg LACIDIPIN 23/04/2015
Lacidipin "Double-E Pharma" filmovertrukne tabletter; 6 mg LACIDIPIN 23/04/2015
Lacosamid "Stada" filmovertrukne tabletter; 100 mg Lacosamid 21/12/2016
Lacosamid "Stada" filmovertrukne tabletter; 150 mg Lacosamid 21/12/2016
Lacosamid "Stada" filmovertrukne tabletter; 200 mg Lacosamid 21/12/2016
Lacosamid "Stada" filmovertrukne tabletter; 50 mg Lacosamid 21/12/2016
Lafene depotplastre; 100 mikrogram/time FENTANYL 20/08/2014
Lafene depotplastre; 12 mikrogram/time FENTANYL 20/08/2014
Lafene depotplastre; 25 mikrogram/time FENTANYL 20/08/2014
Lafene depotplastre; 50 mikrogram/time FENTANYL 20/08/2014
Lafene depotplastre; 75 mikrogram/time FENTANYL 20/08/2014
Lakrimont øjengel; 2 mg/g CARBOMER 17/04/2019
Lamivudine/Zidovudine "Accord" filmovertrukne tabletter; 150+300 mg LAMIVUDIN, ZIDOVUDIN 14/01/2018
Lansopram enterokapsler, hårde; 15 mg LANSOPRAZOL 05/08/2014
Lansopram enterokapsler, hårde; 30 mg LANSOPRAZOL 05/08/2014
Latanoprost "Pfizer" øjendråber, opløsning; 50 mikrogram/ml LATANOPROST 16/03/2018

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