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
Gabapentin "Accord" kapsler, hårde; 300 mg GABAPENTIN 12/09/2016
Gabapentin "Accord" kapsler, hårde; 400 mg GABAPENTIN 12/09/2016
Gabapentin "Aristo" kapsler, hårde; 100 mg GABAPENTIN 01/05/2016
Gabapentin "Aristo" kapsler, hårde; 300 mg GABAPENTIN 01/05/2016
Gabapentin "Aristo" kapsler, hårde; 400 mg GABAPENTIN 01/05/2016
Gabapentin "Glenmark" filmovertrukne tabletter; 600 mg GABAPENTIN 23/06/2017
Gabapentin "Glenmark" filmovertrukne tabletter; 800 mg GABAPENTIN 23/06/2017
Gabapentin "Orion" filmovertrukne tabletter; 600 mg GABAPENTIN 11/05/2017
Gabapentin "Orion" filmovertrukne tabletter; 800 mg GABAPENTIN 11/05/2017
Gablofen injektions-/infusionsvæske, opløsning, fyldt injektionssprøjte; 0,05 mg/ml BACLOFEN 29/07/2015
Gablofen injektions-/infusionsvæske, opløsning, fyldt injektionssprøjte; 0,5 mg/ml BACLOFEN 29/07/2015
Gablofen injektions-/infusionsvæske, opløsning; 0,5 mg/ml BACLOFEN 29/07/2015
Gablofen injektions-/infusionsvæske, opløsning, fyldt injektionssprøjte; 1 mg/ml BACLOFEN 29/07/2015
Gablofen injektions-/infusionsvæske, opløsning; 1 mg/ml BACLOFEN 29/07/2015
Gablofen injektions-/infusionsvæske, opløsning, fyldt injektionssprøjte; 2 mg/ml BACLOFEN 29/07/2015
Gablofen injektions-/infusionsvæske, opløsning; 2 mg/ml BACLOFEN 29/07/2015
Gadograf injektionsvæske, opløsning i fyldt injektionssprøjte; 1 mmol/ml GADOBUTROL 19/06/2019
Gadograf injektionsvæske, opløsning; 1 mmol/ml GADOBUTROL 19/06/2019
Galli Ad radionuklidgenerator; 0,74-1,85 GBq Germanium [Ge-68] tetrachlorid 09/05/2018
Galliapharm radionuklidgenerator; 0,74-1,85 GBq Germanium [Ge-68] tetrachlorid 08/03/2019
Galya øjendråber, opløsning; 40 mikrog/ml+5 mg/ml TIMOLOL, Travoprost 13/10/2017
Gangiden pulver til oral opløsning; KALIUMCHLORID, Macrogol 3350, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 29/08/2014
Gangiden Neutral pulver til oral opløsning; KALIUMCHLORID, Macrogol 3350, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 04/07/2019

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