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
Gefitinib "Accord" filmovertrukne tabletter; 250 mg GEFITINIB 05/12/2018
Gefitinib "Glenmark" filmovertrukne tabletter; 250 mg GEFITINIB 14/08/2018
Gefitinib "Orion" filmovertrukne tabletter; 250 mg GEFITINIB 05/12/2018
Gefitinib "Stada" filmovertrukne tabletter; 250 mg GEFITINIB 11/07/2018
Gefitinib "Teva" filmovertrukne tabletter; 250 mg GEFITINIB 05/10/2018
Gelisse vaginalgel; 50 mikrogram/g ESTRIOL 11/07/2016
Gemcitabin "SUN" infusionsvæske, opløsning; 10 mg/ml GEMCITABINHYDROCHLORID 30/09/2015
Gemind pulver til infusionsvæske, opløsning; 1 g GEMCITABINHYDROCHLORID 08/10/2013
Gemind pulver til infusionsvæske, opløsning; 200 mg GEMCITABINHYDROCHLORID 08/10/2013
Gemkabi koncentrat til infusionsvæske, opløsning; 38 mg/ml GEMCITABINHYDROCHLORID 15/10/2014
Gentamicin "Pharmexon Consulting" injektions-/infusionsvæske, opløsning; 40 mg/ml GENTAMICINSULFAT 10/10/2019
Ghemaxan injektionsvæske, opløsning i fyldt injektionssprøjte; 100 mg ENOXAPARINNATRIUM 08/03/2018
Ghemaxan injektionsvæske, opløsning i fyldt injektionssprøjte; 150 mg ENOXAPARINNATRIUM 08/03/2018
Ghemaxan injektionsvæske, opløsning i fyldt injektionssprøjte; 20 mg ENOXAPARINNATRIUM 08/03/2018
Ghemaxan injektionsvæske, opløsning i fyldt injektionssprøjte; 40 mg ENOXAPARINNATRIUM 08/03/2018
Ghemaxan injektionsvæske, opløsning i fyldt injektionssprøjte; 60 mg ENOXAPARINNATRIUM 08/03/2018
Ghemaxan injektionsvæske, opløsning i fyldt injektionssprøjte; 80 mg ENOXAPARINNATRIUM 08/03/2018

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