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
Quator filmovertrukne tabletter; 10 mg TADALAFIL 15/05/2019
Quator filmovertrukne tabletter; 2,5 mg TADALAFIL 15/05/2019
Quator filmovertrukne tabletter; 20 mg TADALAFIL 15/05/2019
Quator filmovertrukne tabletter; 5 mg TADALAFIL 15/05/2019
Quetamed depottabletter; 150 mg QUETIAPIN FUMARAT 21/06/2019
Quetamed depottabletter; 200 mg QUETIAPIN FUMARAT 21/06/2019
Quetamed depottabletter; 300 mg QUETIAPIN FUMARAT 21/06/2019
Quetamed depottabletter; 400 mg QUETIAPIN FUMARAT 21/06/2019
Quetamed depottabletter; 50 mg QUETIAPIN FUMARAT 21/06/2019
Quetiapin "1A Farma" filmovertrukne tabletter; 100 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "1A Farma" filmovertrukne tabletter; 150 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "1A Farma" filmovertrukne tabletter; 200 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "1A Farma" filmovertrukne tabletter; 25 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "1A Farma" filmovertrukne tabletter; 300 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "1A Farma" filmovertrukne tabletter; 400 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "1A Farma" filmovertrukne tabletter; 50 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Accord" filmovertrukne tabletter; 100 mg QUETIAPIN FUMARAT 15/01/2016
Quetiapin "Accord" depottabletter; 150 mg QUETIAPIN FUMARAT 08/06/2016
Quetiapin "Accord" filmovertrukne tabletter; 200 mg QUETIAPIN FUMARAT 15/01/2016
Quetiapin "Accord" filmovertrukne tabletter; 25 mg QUETIAPIN FUMARAT 15/01/2016
Quetiapin "Accord" filmovertrukne tabletter; 300 mg QUETIAPIN FUMARAT 15/01/2016
Quetiapin "Hexal" filmovertrukne tabletter; 100 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Hexal" depottabletter; 150 mg QUETIAPIN FUMARAT 31/05/2016
Quetiapin "Hexal" depottabletter; 200 mg QUETIAPIN FUMARAT 31/05/2016
Quetiapin "Hexal" filmovertrukne tabletter; 200 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Hexal" filmovertrukne tabletter; 25 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Hexal" depottabletter; 300 mg QUETIAPIN FUMARAT 31/05/2016
Quetiapin "Hexal" filmovertrukne tabletter; 300 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Hexal" depottabletter; 400 mg QUETIAPIN FUMARAT 31/05/2016
Quetiapin "Hexal" depottabletter; 50 mg QUETIAPIN FUMARAT 31/05/2016
Quetiapin "Krka" depottabletter; 400 mg QUETIAPIN FUMARAT 21/06/2018
Quetiapin "KRKA" depottabletter; 150 mg QUETIAPIN FUMARAT 15/10/2015
Quetiapin "KRKA" depottabletter; 200 mg QUETIAPIN FUMARAT 15/10/2015
Quetiapin "KRKA" depottabletter; 300 mg QUETIAPIN FUMARAT 15/10/2015
Quetiapin "KRKA" depottabletter; 50 mg QUETIAPIN FUMARAT 15/10/2015
Quetiapin "Medical Valley" depottabletter; 150 mg QUETIAPIN FUMARAT 02/03/2018
Quetiapin "Medical Valley" depottabletter; 200 mg QUETIAPIN FUMARAT 02/03/2018
Quetiapin "Medical Valley" depottabletter; 300 mg QUETIAPIN FUMARAT 02/03/2018
Quetiapin "Medical Valley" depottabletter; 400 mg QUETIAPIN FUMARAT 02/03/2018
Quetiapin "Medical Valley" depottabletter; 50 mg QUETIAPIN FUMARAT 02/03/2018
Quetiapin "Orion" filmovertrukne tabletter; 100 mg QUETIAPIN FUMARAT 20/12/2018
Quetiapin "Orion" filmovertrukne tabletter; 200 mg QUETIAPIN FUMARAT 20/12/2018
Quetiapin "Orion" filmovertrukne tabletter; 25 mg QUETIAPIN FUMARAT 20/12/2018
Quetiapin "Orion" filmovertrukne tabletter; 300 mg QUETIAPIN FUMARAT 20/12/2018
Quetiapin "Sandoz" filmovertrukne tabletter; 100 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Sandoz" filmovertrukne tabletter; 150 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Sandoz" filmovertrukne tabletter; 200 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Sandoz" filmovertrukne tabletter; 25 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Sandoz" filmovertrukne tabletter; 300 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Sandoz" filmovertrukne tabletter; 50 mg QUETIAPIN FUMARAT 10/03/2016
Quetiapin "Zentiva" depottabletter; 150 mg QUETIAPIN FUMARAT 28/04/2016
Quetiapin "Zentiva" depottabletter; 200 mg QUETIAPIN FUMARAT 28/04/2016
Quetiapin "Zentiva" depottabletter; 300 mg QUETIAPIN FUMARAT 28/04/2016
Quetiapin "Zentiva" depottabletter; 400 mg QUETIAPIN FUMARAT 28/04/2016
Quetiapin "Zentiva" depottabletter; 50 mg QUETIAPIN FUMARAT 28/04/2016
Quetiapine "Teva" depottabletter; 150 mg QUETIAPIN FUMARAT 03/04/2020
Quetiapine "Teva" depottabletter; 200 mg QUETIAPIN FUMARAT 03/04/2020
Quetiapine "Teva" depottabletter; 300 mg QUETIAPIN FUMARAT 03/04/2020
Quetiapine "Teva" depottabletter; 400 mg QUETIAPIN FUMARAT 03/04/2020
Quetiapine "Teva" depottabletter; 50 mg QUETIAPIN FUMARAT 03/04/2020
Quintasa Sachet depotgranulat; 4 g MESALAZIN 01/10/2014

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