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
Cabazitaxel "Ever Pharma" koncentrat til infusionsvæske, opløsning; 10 mg/ml Cabazitaxel 24/07/2020
Cabazitaxel "Sandoz" koncentrat til infusionsvæske, opløsning; 10 mg/ml Cabazitaxelmonohydrat 15/09/2020
Cabazitaxel "Teva B.V." koncentrat til infusionsvæske, opløsning; 10 mg/ml Cabazitaxelethylacetat 31/07/2020
Calcichew-D3 Forte tyggetabletter; 500 mg+10 mikrogram Calciumcarbonat, Cholecalciferol 05/03/2015
Calcipotriol/Betamethasone "Sandoz" salve; 50 mikrog/g+0,5 mg/g BETAMETHASON, Calcipotriol 14/12/2015
Calciumfolinat "Fresenius Kabi" injektions-/infusionsvæske, opløsning; 10 mg/ml Calciumfolinat 15/10/2015
Calciumfolinate "Sandoz" injektions-/infusionsvæske, opløsning; 10 mg/ml Calciumfolinat 04/11/2016
Calrecia infusionsvæske, opløsning; 100 mmol/l CALCIUMCHLORIDDIHYDRAT 14/11/2018
Canderion tabletter; 16 mg CANDESARTANCILEXETIL 20/02/2018
Canderion tabletter; 32 mg CANDESARTANCILEXETIL 20/02/2018
Canderion tabletter; 4 mg CANDESARTANCILEXETIL 20/02/2018
Canderion tabletter; 8 mg CANDESARTANCILEXETIL 20/02/2018
Candesartan/Hydrochlorothiazide "Orion" tabletter; 16+12,5 mg CANDESARTANCILEXETIL, HYDROCHLORTHIAZID 28/08/2015
Candesartan/Hydrochlorothiazide "Orion" tabletter; 32+12,5 mg CANDESARTANCILEXETIL, HYDROCHLORTHIAZID 28/08/2015
Candesartan/Hydrochlorothiazide "Orion" tabletter; 32+25 mg CANDESARTANCILEXETIL, HYDROCHLORTHIAZID 28/08/2015
Candesartan/Hydrochlorothiazide "Orion" tabletter; 8+12,5 mg CANDESARTANCILEXETIL, HYDROCHLORTHIAZID 28/08/2015
Candesartan/Hydrochlorthiazid "Actavis" tabletter; 32+12,5 mg CANDESARTANCILEXETIL, HYDROCHLORTHIAZID 30/09/2013
Candesartan/Hydrochlorthiazid "Actavis" tabletter; 32+25 mg CANDESARTANCILEXETIL, HYDROCHLORTHIAZID 30/09/2013
Candezek Combi kapsler, hårde; 16+10 mg AMLODIPINBESILAT, CANDESARTANCILEXETIL 26/02/2020
Candezek Combi kapsler, hårde; 16+5 mg AMLODIPINBESILAT, CANDESARTANCILEXETIL 26/02/2020
Candezek Combi kapsler, hårde; 8+10 mg AMLODIPINBESILAT, CANDESARTANCILEXETIL 26/02/2020
Candezek Combi kapsler, hårde; 8+5 mg AMLODIPINBESILAT, CANDESARTANCILEXETIL 26/02/2020
Capecitabin "Fair-Med" filmovertrukne tabletter; 150 mg CAPECITABIN 04/02/2015
Capecitabin "Fair-Med" filmovertrukne tabletter; 500 mg CAPECITABIN 04/02/2015
Capecitabin "Koanaa" filmovertrukne tabletter; 150 mg CAPECITABIN 20/03/2019
Capecitabin "Koanaa" filmovertrukne tabletter; 500 mg CAPECITABIN 20/03/2019
Capecitabine "Orion" filmovertrukne tabletter; 150 mg CAPECITABIN 24/01/2017
Capecitabine "Orion" filmovertrukne tabletter; 500 mg CAPECITABIN 24/01/2017
Carbimazole "Orifarm" tabletter; 10 mg CARBIMAZOL 11/04/2019
Carbimazole "Orifarm" tabletter; 15 mg CARBIMAZOL 11/04/2019
Carbimazole "Orifarm" tabletter; 20 mg CARBIMAZOL 11/04/2019
Carbimazole "Orifarm" tabletter; 5 mg CARBIMAZOL 11/04/2019
Cardiospir filmovertrukne tabletter; 5 mg BISOPROLOLFUMARAT 22/02/2018
Cardiospir Plus filmovertrukne tabletter; 10+25 mg BISOPROLOLFUMARAT, HYDROCHLORTHIAZID 22/11/2018
Cardiospir Plus filmovertrukne tabletter; 5+12,5 mg BISOPROLOLFUMARAT, HYDROCHLORTHIAZID 22/11/2018
Carditimib tabletter; 10 mg EZETIMIB 18/11/2015
Carivalan filmovertrukne tabletter; 25+7,5 mg CARVEDILOL, ivabradinhydrochlorid 09/11/2016
Carivalan filmovertrukne tabletter; 6,25+5 mg CARVEDILOL, ivabradinhydrochlorid 09/11/2016
Carmustine "Macure" pulver og solvens til koncentrat til infusionsvæske, opløsning; 100 mg carmustin 17/04/2019
Casmyg pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT 15/12/2016
Casmyg pulver til koncentrat til infusionsvæske, opløsning; 70 mg CASPOFUNGINACETAT 15/12/2016
Casodex filmovertrukne tabletter; 150 mg BICALUTAMID 10/10/2014
Caspofungin "Lorien" pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT 27/09/2016
Caspofungin "Lorien" pulver til koncentrat til infusionsvæske, opløsning; 70 mg CASPOFUNGINACETAT 27/09/2016
Caspofungin "Mylan" pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT 23/10/2018
Caspofungin "Mylan" pulver til koncentrat til infusionsvæske, opløsning; 70 mg CASPOFUNGINACETAT 23/10/2018
Caspofungin "Orion" pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT 08/12/2016
Caspofungin "Sandoz" pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT 30/07/2018
Caspofungin "Sandoz" pulver til koncentrat til infusionsvæske, opløsning; 70 mg CASPOFUNGINACETAT 30/07/2018
Caspofungin "Stada" pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT
Caspofungin "Stada" pulver til koncentrat til infusionsvæske, opløsning; 70 mg CASPOFUNGINACETAT
Caspofungin "SUN" pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT 15/12/2016
Caspofungin "SUN" pulver til koncentrat til infusionsvæske, opløsning; 70 mg CASPOFUNGINACETAT 15/12/2016
Caspofungin "Teva B.V." pulver til koncentrat til infusionsvæske, opløsning; 50 mg CASPOFUNGINACETAT 26/03/2020
Caspofungin "Teva B.V." pulver til koncentrat til infusionsvæske, opløsning; 70 mg CASPOFUNGINACETAT 26/03/2020

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