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
Brevibloc injektionsvæske, opløsning; 10 mg/ml ESMOLOLHYDROCHLORID 28/06/2018
Brevibloc infusionsvæske, opløsning; 10 mg/ml ESMOLOLHYDROCHLORID 28/06/2018
Brimonidine/Timolol "Stada" øjendråber, opløsning; 2+5 mg/ml BRIMONIDINTARTRAT, TIMOLOLMALEAT 09/03/2015
Brimonidintartrat "1A Farma" øjendråber, opløsning; 2 mg/ml BRIMONIDINTARTRAT 28/04/2016
Brinzolamid "Stada" øjendråber, suspension; 10 mg/ml Brinzolamid 18/02/2015
Brinzolamide "Sandoz" øjendråber, suspension; 10 mg/ml Brinzolamid 01/06/2017
Budenofalk enterokapsler, hårde; 3 mg BUDESONID 18/12/2019
Budesonide "Teva Pharma" inhalationsvæske til nebulisator, suspension; 0,25 mg/ml BUDESONID 30/07/2017
Budesonide "Teva Pharma" inhalationsvæske til nebulisator, suspension; 0,5 mg/ml BUDESONID 30/07/2017
Bufomix Easyhaler inhalationspulver; 4,5+160 mikrog/dosis BUDESONID, FORMOTEROLFUMARAT DIHYDRAT 22/02/2018
Bufomix Easyhaler inhalationspulver; 4,5+80 mikrog/dosis BUDESONID, FORMOTEROLFUMARAT DIHYDRAT 22/02/2018
Bufomix Easyhaler inhalationspulver; 9+320 mikrog/dosis BUDESONID, FORMOTEROLFUMARAT DIHYDRAT 22/02/2018
Buprenorphine "Sandoz" depotplastre; 10 mikrogram/time BUPRENORPHIN 12/01/2016
Buprenorphine "Sandoz" depotplastre; 15 mikrogram/time BUPRENORPHIN 12/01/2016
Buprenorphine "Sandoz" resoribletter, sublinguale; 2 mg BUPRENORPHINHYDROCHLORID 04/11/2015
Buprenorphine "Sandoz" depotplastre; 20 mikrogram/time BUPRENORPHIN 12/01/2016
Buprenorphine "Sandoz" depotplastre; 5 mikrogram/time BUPRENORPHIN 12/01/2016
Buprenorphine "Sandoz" resoribletter, sublinguale; 8 mg BUPRENORPHINHYDROCHLORID 04/11/2015
Busalair inhalationspulver, hård kapsel; 120 mikrog+20 mikrog BUDESONID, SALMETEROLXINAFOAT 23/07/2015
BuTrans depotplastre; 10 mikrogram/time BUPRENORPHIN 05/03/2018
BuTrans depotplastre; 20 mikrogram/time BUPRENORPHIN 05/03/2018
BuTrans depotplastre; 5 mikrogram/time BUPRENORPHIN 05/03/2018