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
Dacarbazine "Lipomed" pulver til infusionsvæske, opløsning; 1000 mg DACARBAZIN 10/02/2017
Dacarbazine "Lipomed" pulver til infusionsvæske, opløsning; 500 mg DACARBAZIN 10/02/2017
Dacepton injektionsvæske, opløsning i cylinderampul; 10 mg/ml Apomorphinhydrochlorid hemihydrat 07/04/2016
Dailiport depotkapsler, hårde; 0,5 mg Tacrolimusmonohydrat 18/09/2019
Dailiport depotkapsler, hårde; 1 mg Tacrolimusmonohydrat 18/09/2019
Dailiport depotkapsler, hårde; 2 mg Tacrolimusmonohydrat 18/09/2019
Dailiport depotkapsler, hårde; 3 mg Tacrolimusmonohydrat 18/09/2019
Dailiport depotkapsler, hårde; 5 mg Tacrolimusmonohydrat 18/09/2019
Daivobet gel; 50 mikrog/g+0,5 mg/g BETAMETHASONDIPROPIONAT, Calcipotriol Hydrate 15/06/2017
Daltex filmovertrukne tabletter; 50+1000 mg METFORMINHYDROCHLORID, Vildagliptin 20/11/2019
Daltex filmovertrukne tabletter; 50+850 mg METFORMINHYDROCHLORID, Vildagliptin 20/11/2019
Dalvocans pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT 15/12/2016
Dalvocans pulver til koncentrat til infusionsvæske, opløsning; 70 mg CASPOFUNGINACETAT 15/12/2016
Dansiglat enterotabletter; 20 mg Esomeprazolmagnesiumdihydrat 14/07/2014
Dansiglat enterotabletter; 40 mg Esomeprazolmagnesiumdihydrat 14/07/2014
Dantrium pulver til injektionsvæske, opløsning; 20 mg DANTROLENNATRIUM 10/12/2018
Daptomycin "Accordpharma" pulver til injektions-/infusionsvæske, opløsning; 350 mg Daptomycin 15/10/2019
Daptomycin "Accordpharma" pulver til injektions-/infusionsvæske, opløsning; 500 mg Daptomycin 15/10/2019
Daptomycin "Reddy" pulver til injektions-/infusionsvæske, opløsning; 350 mg Daptomycin 17/05/2017
Daptomycin "Reddy" pulver til injektions-/infusionsvæske, opløsning; 500 mg Daptomycin 17/05/2017
Darunavir "Accord" filmovertrukne tabletter; 150 mg Darunavirpropylenglycolat 18/09/2019
Darunavir "Accord" filmovertrukne tabletter; 300 mg Darunavirpropylenglycolat 18/09/2019
Darunavir "Accord" filmovertrukne tabletter; 400 mg Darunavirpropylenglycolat 18/09/2019
Darunavir "Accord" filmovertrukne tabletter; 600 mg Darunavirpropylenglycolat 18/09/2019
Darunavir "Accord" filmovertrukne tabletter; 75 mg Darunavirpropylenglycolat 18/09/2019
Darunavir "Accord" filmovertrukne tabletter; 800 mg Darunavirpropylenglycolat 18/09/2019
Darunavir "Dr. Reddy's" filmovertrukne tabletter; 150 mg Darunavirpropylenglycolat 04/07/2018
Darunavir "Dr. Reddy's" filmovertrukne tabletter; 400 mg Darunavirpropylenglycolat 04/07/2018
Darunavir "Dr. Reddy's" filmovertrukne tabletter; 600 mg Darunavirpropylenglycolat 04/07/2018
Darunavir "Dr. Reddy's" filmovertrukne tabletter; 75 mg Darunavirpropylenglycolat 04/07/2018
Darunavir "Dr. Reddy's" filmovertrukne tabletter; 800 mg Darunavirpropylenglycolat 04/07/2018
Darunavir "Glenmark" filmovertrukne tabletter; 400 mg Darunavirpropylenglycolat 21/12/2018
Darunavir "Glenmark" filmovertrukne tabletter; 600 mg Darunavirpropylenglycolat 21/12/2018
Darunavir "Glenmark" filmovertrukne tabletter; 800 mg Darunavirpropylenglycolat 21/12/2018
Darunavir "Medical Valley" filmovertrukne tabletter; 400 mg Darunavirpropylenglycolat 02/05/2018
Darunavir "Medical Valley" filmovertrukne tabletter; 600 mg Darunavirpropylenglycolat 02/05/2018
Darunavir "Medical Valley" filmovertrukne tabletter; 800 mg Darunavirpropylenglycolat 02/05/2018
Darunavir "Sandoz" filmovertrukne tabletter; 600 mg Darunavir 15/02/2017
Darunavir "Sandoz" filmovertrukne tabletter; 75 mg Darunavir 15/02/2017
Darunavir "Sandoz" filmovertrukne tabletter; 800 mg Darunavir 15/02/2017
Darunavir "Stada" filmovertrukne tabletter; 400 mg Darunavir 15/02/2017
Darunavir "Stada" filmovertrukne tabletter; 600 mg Darunavir 15/02/2017
Darunavir "Stada" filmovertrukne tabletter; 800 mg Darunavir 15/02/2017
Darunavir "Teva" filmovertrukne tabletter; 600 mg Darunavirethanolat 06/09/2018
Darunavir "Teva" filmovertrukne tabletter; 800 mg Darunavir 13/09/2017
Dasatinib "Alvogen" filmovertrukne tabletter; 100 mg Dasatinib 08/11/2019
Dasatinib "Alvogen" filmovertrukne tabletter; 140 mg Dasatinib 08/11/2019
Dasatinib "Alvogen" filmovertrukne tabletter; 20 mg Dasatinib 08/11/2019
Dasatinib "Alvogen" filmovertrukne tabletter; 50 mg Dasatinib 08/11/2019
Dasatinib "Alvogen" filmovertrukne tabletter; 70 mg Dasatinib 08/11/2019
Dasatinib "Alvogen" filmovertrukne tabletter; 80 mg Dasatinib 08/11/2019
Dasatinib "Krka" filmovertrukne tabletter; 100 mg Dasatinib 07/08/2019
Dasatinib "Krka" filmovertrukne tabletter; 140 mg Dasatinib 07/08/2019
Dasatinib "Krka" filmovertrukne tabletter; 20 mg Dasatinib 07/08/2019
Dasatinib "Krka" filmovertrukne tabletter; 50 mg Dasatinib 07/08/2019
Dasatinib "Krka" filmovertrukne tabletter; 70 mg Dasatinib 07/08/2019
Dasatinib "Krka" filmovertrukne tabletter; 80 mg Dasatinib 07/08/2019
Dasatinib "Mylan" filmovertrukne tabletter; 100 mg Dasatinib 07/08/2019
Dasatinib "Mylan" filmovertrukne tabletter; 20 mg Dasatinib 07/08/2019
Dasatinib "Mylan" filmovertrukne tabletter; 50 mg Dasatinib 07/08/2019
Dasatinib "Mylan" filmovertrukne tabletter; 70 mg Dasatinib 07/08/2019
Dasatinib "Mylan" filmovertrukne tabletter; 80 mg Dasatinib 07/08/2019
Dasatinib "Sandoz" filmovertrukne tabletter; 100 mg Dasatinib 07/05/2019
Dasatinib "Sandoz" filmovertrukne tabletter; 140 mg Dasatinib 07/05/2019
Dasatinib "Sandoz" filmovertrukne tabletter; 20 mg Dasatinib 07/05/2019
Dasatinib "Sandoz" filmovertrukne tabletter; 50 mg Dasatinib 07/05/2019
Dasatinib "Sandoz" filmovertrukne tabletter; 70 mg Dasatinib 07/05/2019
Dasatinib "Stada" filmovertrukne tabletter; 20 mg Dasatinib 25/07/2018
Dasatinib "Teva B.V." filmovertrukne tabletter; 100 mg Dasatinib 06/09/2019
Dasatinib "Teva B.V." filmovertrukne tabletter; 140 mg Dasatinib 06/09/2019
Dasatinib "Teva B.V." filmovertrukne tabletter; 20 mg Dasatinib 06/09/2019
Dasatinib "Teva B.V." filmovertrukne tabletter; 50 mg Dasatinib 06/09/2019
Dasatinib "Teva B.V." filmovertrukne tabletter; 70 mg Dasatinib 06/09/2019
Dasatinib "Teva B.V." filmovertrukne tabletter; 80 mg Dasatinib 06/09/2019
Dasatinib "Teva" filmovertrukne tabletter; 100 mg Dasatinib 13/12/2018
Dasatinib "Teva" filmovertrukne tabletter; 20 mg Dasatinib 13/12/2018
Dasatinib "Teva" filmovertrukne tabletter; 50 mg Dasatinib 13/12/2018
Dasatinib "Teva" filmovertrukne tabletter; 70 mg Dasatinib 13/12/2018
Dasatinib "Teva" filmovertrukne tabletter; 80 mg Dasatinib 13/12/2018
Datolsigla filmovertrukne tabletter; 10 mg Solifenacinsuccinat 29/11/2018
Datolsigla filmovertrukne tabletter; 5 mg Solifenacinsuccinat 29/11/2018
Davarino filmovertrukne tabletter; 150 mg Darunavir 15/11/2017
Davarino filmovertrukne tabletter; 300 mg Darunavir 15/11/2017
Davarino filmovertrukne tabletter; 400 mg Darunavir 15/11/2017
Davarino filmovertrukne tabletter; 600 mg Darunavir 15/11/2017
Davarino filmovertrukne tabletter; 75 mg Darunavir 15/11/2017
Davarino filmovertrukne tabletter; 800 mg Darunavir 15/11/2017
Dazonay filmovertrukne tabletter; 100+25+200 mg CARBIDOPA, ENTACAPON, LEVODOPA 03/12/2015
Dazonay filmovertrukne tabletter; 125+31,25+200 mg CARBIDOPA, ENTACAPON, LEVODOPA 03/12/2015
Dazonay filmovertrukne tabletter; 150+37,5+200 mg CARBIDOPA, ENTACAPON, LEVODOPA 03/12/2015
Dazonay filmovertrukne tabletter; 200+50+200 mg CARBIDOPA, ENTACAPON, LEVODOPA 03/12/2015
Dazonay filmovertrukne tabletter; 50+12,5+200 mg CARBIDOPA, ENTACAPON, LEVODOPA 03/12/2015
Dazonay filmovertrukne tabletter; 75+18,75+200 mg CARBIDOPA, ENTACAPON, LEVODOPA 03/12/2015

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.


...