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
Zodediab MR tabletter med modificeret udløsning; 30 mg GLICLAZID 26/06/2014
Zodediab MR tabletter med modificeret udløsning; 60 mg GLICLAZID 26/06/2014
Zofran oral opløsning; 0,8 mg/ml ONDANSETRONHYDROCHLORIDDIHYDRAT 07/11/2016
Zofran suppositorier; 16 mg ONDANSETRON 07/11/2016
Zofran injektionsvæske, opløsning; 2 mg/ml ONDANSETRONHYDROCHLORIDDIHYDRAT 07/11/2016
Zofran frysetørret tablet; 4 mg ONDANSETRON 07/11/2016
Zofran frysetørret tablet; 8 mg ONDANSETRON 07/11/2016
Zolbrinex øjendråber, opløsning; 2+5 mg/ml BRIMONIDINTARTRAT, TIMOLOLMALEAT 29/06/2016
Zoledo infusionsvæske, opløsning; 0,04 mg/ml ZOLEDRONSYRE, VANDFRI 13/04/2018
Zoledronsyre "Fresenius Kabi" koncentrat til infusionsvæske, opløsning; 4 mg/5 ml ZOLEDRONSYRE, MONOHYDRAT 02/09/2016
Zoledronsyre "Sandoz" infusionsvæske, opløsning; 4 mg/100 ml ZOLEDRONSYRE, MONOHYDRAT 05/10/2016
Zoledronsyre "Stada" koncentrat til infusionsvæske, opløsning; 4 mg/5 ml ZOLEDRONSYRE, MONOHYDRAT 14/07/2016
Zoledronsyre "SUN" infusionsvæske, opløsning; 5 mg/100 ml ZOLEDRONSYRE, MONOHYDRAT 24/05/2018
Zolpidem "Dune" filmovertrukne tabletter; 10 mg ZOLPIDEM TARTRAT 02/10/2014
Zolpidem "Dune" filmovertrukne tabletter; 5 mg ZOLPIDEM TARTRAT 02/10/2014
Zomacton pulver og solvens til injektionsvæske, opløsning; 10 mg/ml SOMATROPIN 08/04/2015
Zomacton pulver og solvens til injektionsvæske, opløsning; 4 mg SOMATROPIN 08/04/2015
Zonisamid "EQL Pharma" kapsler, hårde; 100 mg ZONISAMID 26/09/2016
Zonisamid "EQL Pharma" kapsler, hårde; 25 mg ZONISAMID 26/09/2016
Zonisamid "EQL Pharma" kapsler, hårde; 50 mg ZONISAMID 26/09/2016
Zonisamid "Glenmark" kapsler, hårde; 100 mg ZONISAMID 08/11/2017
Zonisamid "Glenmark" kapsler, hårde; 25 mg ZONISAMID 08/11/2017
Zonisamid "Glenmark" kapsler, hårde; 50 mg ZONISAMID 08/11/2017
Zonisamide "1A Farma" kapsler, hårde; 100 mg ZONISAMID 09/03/2016
Zonisamide "1A Farma" kapsler, hårde; 25 mg ZONISAMID 09/03/2016
Zonisamide "1A Farma" kapsler, hårde; 50 mg ZONISAMID 09/03/2016
Zonisamide "Teva" kapsler, hårde; 100 mg ZONISAMID 28/10/2015
Zonisamide "Teva" kapsler, hårde; 25 mg ZONISAMID 28/10/2015
Zonisamide "Teva" kapsler, hårde; 50 mg ZONISAMID 28/10/2015
Zonnic Freshmint mundhulepulver, portionspose; 4 mg Nicotin 24/03/2015
Zonnic Mint sugetabletter; 2 mg NICOTINBITARTRATDIHYDRAT 30/11/2015
Zonnic Mint sugetabletter; 4 mg NICOTINBITARTRATDIHYDRAT 30/11/2015
Zonnic Peppermint mundhulespray, opløsning; 1 mg/dosis Nicotin 24/03/2015
Zopiclone "Orion" filmovertrukne tabletter; 3,75 mg ZOPICLON 30/11/2016
Zopiclone "Orion" filmovertrukne tabletter; 7,5 mg ZOPICLON 30/11/2016

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