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
Vadyrano filmovertrukne tabletter; 5 mg ivabradinhydrochlorid 19/12/2016
Vadyrano filmovertrukne tabletter; 7,5 mg ivabradinhydrochlorid 19/12/2016
Vagiprev vaginalindlæg; 120+15 mikrogr/24 t Ethinylestradiol, ETONOGESTREL 18/05/2017
Valganciclovir "Orion" filmovertrukne tabletter; 450 mg VALGANCICLOVIRHYDROCHLORID 08/10/2014
Valganciclovir "Medical Valley" filmovertrukne tabletter; 450 mg VALGANCICLOVIRHYDROCHLORID 24/09/2018
Valganciclovir "Sandoz" filmovertrukne tabletter; 450 mg VALGANCICLOVIRHYDROCHLORID 10/11/2014
Valproat "Life Medical" injektions-/infusionsvæske, opløsning; 100 mg/ml NATRIUMVALPROAT 16/01/2020
Valsartan/hydroklortiazid "Jubilant" filmovertrukne tabletter; 160 mg+25 mg HYDROCHLORTHIAZID, VALSARTAN 16/06/2015
Valsartan/hydroklortiazid "Jubilant" filmovertrukne tabletter; 80 mg+12,5 mg HYDROCHLORTHIAZID, VALSARTAN 16/06/2015
Vancomycin "Orion" pulver til koncentrat til infusionsvæske, opløsning; 1000 mg VANCOMYCINHYDROCHLORID 25/07/2018
Vancomycin "Orion" pulver til koncentrat til infusionsvæske, opløsning; 500 mg VANCOMYCINHYDROCHLORID 25/07/2018
Vancomycin "Reig Jofre" pulver til koncentrat til infusionsvæske, opløsning; 1000 mg VANCOMYCIN 11/07/2016
Vancomycin "Reig Jofre" pulver til koncentrat til infusionsvæske, opløsning; 500 mg VANCOMYCIN 11/07/2016
Vancomycin "Strides" kapsler, hårde; 125 mg VANCOMYCINHYDROCHLORID 09/08/2017
Vancomycin "Strides" kapsler, hårde; 250 mg VANCOMYCINHYDROCHLORID 09/08/2017
Vardenafil "Accord" filmovertrukne tabletter; 10 mg Vardenafilhydrochloridtrihydrat 22/05/2017
Vardenafil "Accord" filmovertrukne tabletter; 20 mg Vardenafilhydrochloridtrihydrat 22/05/2017
Vardenafil "Accord" filmovertrukne tabletter; 5 mg Vardenafilhydrochloridtrihydrat 22/05/2017
Vardenafil "Krka" filmovertrukne tabletter; 10 mg Vardenafilhydrochloridtrihydrat 16/02/2017
Vardenafil "Krka" filmovertrukne tabletter; 20 mg Vardenafilhydrochloridtrihydrat 16/02/2017
Vardenafil "Krka" filmovertrukne tabletter; 5 mg Vardenafilhydrochloridtrihydrat 16/02/2017
Vardenafil "Rivopharm" tabletter; 10 mg Vardenafilhydrochloridtrihydrat 01/11/2017
Vardenafil "Rivopharm" tabletter; 20 mg Vardenafilhydrochloridtrihydrat 01/11/2017
Vardenafil "Rivopharm" tabletter; 5 mg Vardenafilhydrochloridtrihydrat 01/11/2017
Vasitimb tabletter; 10+10 mg EZETIMIB, SIMVASTATIN 04/07/2017
Vasitimb tabletter; 10+20 mg EZETIMIB, SIMVASTATIN 04/07/2017
Vasitimb tabletter; 10+40 mg EZETIMIB, SIMVASTATIN 04/07/2017
Vasokinox medicinsk gas, komprimeret; 450 ppm Nitrogenoxid 28/07/2016
Vasokinox medicinsk gas, komprimeret; 800 ppm Nitrogenoxid 04/05/2017
Vaxigriptetra injektionsvæske, suspension, fyldt injektionssprøjte; Influenzavirus A/California/7/2009 (H1N1)v-lign. stamme (X-179A), inaktiverede split virioner, Influenzavirus A/Texas/50/2012 (H3N2) lign. stamme (A/Texas/50/2012, NYMC X-223A), inaktiv. split v., Influenzavirus B/Brisbane/60/2008, split virioner, inaktiveret, Influenzavirus B/Massachusetts/2/2012 (Yamagata lineage), inaktiverede split virioner 21/06/2016

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