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 |
Imatinib "Cipla" | kapsler, hårde; | 100 mg | IMATINIBMESILAT | 01/05/2015 |
Imatinib "Cipla" | kapsler, hårde; | 400 mg | IMATINIBMESILAT | 01/05/2015 |
Imatinib "Krka d.d." | filmovertrukne tabletter; | 100 mg | IMATINIBMESILAT | 13/06/2022 |
Imatinib "Krka d.d." | filmovertrukne tabletter; | 400 mg | IMATINIBMESILAT | 13/06/2022 |
Imatinib "Sandoz" | filmovertrukne tabletter; | 100 mg | IMATINIBMESILAT | 14/10/2015 |
Imatinib "Sandoz" | filmovertrukne tabletter; | 400 mg | IMATINIBMESILAT | 14/10/2015 |
Imatinib "Stada" | kapsler, hårde; | 100 mg | IMATINIBMESILAT | 16/06/2016 |
Imatinib "Stada" | filmovertrukne tabletter; | 100 mg | IMATINIBMESILAT | 27/05/2015 |
Imatinib "Stada" | kapsler, hårde; | 400 mg | IMATINIBMESILAT | 16/06/2016 |
Imatinib "Stada" | filmovertrukne tabletter; | 400 mg | IMATINIBMESILAT | 27/05/2015 |
Imatinib "STADA" | filmovertrukne tabletter; | 600 mg | IMATINIBMESILAT | 04/05/2021 |
Imatinib "Viatris" | filmovertrukne tabletter; | 100 mg | IMATINIBMESILAT | 02/09/2016 |
Imatinib "Viatris" | filmovertrukne tabletter; | 400 mg | IMATINIBMESILAT | 02/09/2016 |
Imaxi | pulver til oral suspension; | 50 mg/ml | AMOXICILLINTRIHYDRAT | 18/01/2019 |
Imodium | tabletter; | 2 mg | LOPERAMIDHYDROCHLORID | 21/10/2023 |
Imodium Plus | tabletter; | 2 mg + 125 mg | LOPERAMIDHYDROCHLORID, SIMETICON | 21/10/2023 |
Imodium Smelt | frysetørret tablet; | 2 mg | LOPERAMIDHYDROCHLORID | 21/10/2023 |
Imogas | kapsler, bløde; | 240 mg | SIMETICON | 27/07/2018 |
Imolope | tabletter; | 2 mg | LOPERAMIDHYDROCHLORID | 18/05/2018 |
Imolopesim | tabletter; | 2+125 mg | LOPERAMIDHYDROCHLORID, SIMETICON | 14/07/2015 |
Inatord | injektionsvæske, opløsning i fyldt pen; | 6 mg/ml | Liraglutid | 12/06/2024 |
Inegy | tabletter; | 10 mg+10 mg | EZETIMIB, SIMVASTATIN | 10/07/2017 |
Inegy | tabletter; | 10 mg+20 mg | EZETIMIB, SIMVASTATIN | 10/07/2017 |
Inegy | tabletter; | 10 mg+40 mg | EZETIMIB, SIMVASTATIN | 10/07/2017 |
Inegy | tabletter; | 10 mg+80 mg | EZETIMIB, SIMVASTATIN | 10/07/2017 |
Infilea | shampoo; | 500 mikrogram/g | Clobetasolpropionat | 14/09/2023 |
Influvac | injektionsvæske, suspension, fyldt injektionssprøjte; | A/Darwin/9/2021 (H3N2) - lignende stamme (A/Darwin/9/2021, SAN-010), A/Victoria/4897/2022 (H1N1)pdm09 - lignende stamme (A/Victoria/4897/2022 IVR-238) (inaktiveret), B/Austria/1359417/2021 - lignende stamme (B/Austria/1359417/2021 BVR-26) (inaktiveret) | 15/05/2024 | |
Influvactetra | injektionsvæske, suspension, fyldt injektionssprøjte; | A/Darwin/9/2021 (H3N2) - lignende stamme (A/Darwin/9/2021, IVR-228), A/Victoria/4897/2022 (H1N1)pdm09 - lignende stamme (A/Victoria/4897/2022 IVR-238) (inaktiveret), B/Austria/1359417/2021 - lignende stamme (B/Michigan/01/2021, vildtype), B/Phuket/3073/2013-lignende stamme (B/Phuket/3073/2013, vild type) | 18/03/2019 | |
Injexate | injektionsvæske, opløsning i fyldt injektionssprøjte; | 50 mg/ml | METHOTREXAT | 01/10/2015 |
Innohep | injektionsvæske, opløsning i fyldt injektionssprøjte; | 10.000 anti-Xa IE | TINZAPARINNATRIUM | 12/01/2018 |
Innohep | injektionsvæske, opløsning; | 10.000 anti-Xa IE/ml | TINZAPARINNATRIUM | 10/02/2017 |
Innohep | injektionsvæske, opløsning i fyldt injektionssprøjte; | 12.000 anti-Xa IE | TINZAPARINNATRIUM | 12/01/2018 |
Innohep | injektionsvæske, opløsning i fyldt injektionssprøjte; | 14.000 anti-Xa IE | TINZAPARINNATRIUM | 12/01/2018 |
Innohep | injektionsvæske, opløsning i fyldt injektionssprøjte; | 16.000 anti-Xa IE | TINZAPARINNATRIUM | 12/01/2018 |
Innohep | injektionsvæske, opløsning i fyldt injektionssprøjte; | 18.000 anti-Xa IE | TINZAPARINNATRIUM | 12/01/2018 |
Innohep | injektionsvæske, opløsning; | 20.000 anti-Xa IE/ml | TINZAPARINNATRIUM | 12/01/2018 |
Innohep | injektionsvæske, opløsning i fyldt injektionssprøjte; | 8.000 anti-Xa IE | TINZAPARINNATRIUM | 12/01/2018 |
Innovair | inhalationsspray, opløsning; | 100+6 mikrog./dosis | BECLOMETASONDIPROPIONAT, FORMOTEROLFUMARAT DIHYDRAT | 01/03/2017 |
Innovair | inhalationsspray, opløsning; | 200+6 mikrog./dosis | BECLOMETASONDIPROPIONAT, FORMOTEROLFUMARAT DIHYDRAT | 15/07/2015 |
Innovair Nexthaler | inhalationspulver; | 100+6 mikrog./dosis | BECLOMETASONDIPROPIONAT, FORMOTEROLFUMARAT DIHYDRAT | 06/10/2017 |
Instillido | gel; | 20 mg/ml | Lidocainhydrochloridmonohydrat | 03/11/2021 |
Intestat | tabletter; | 10 mg | EZETIMIB | 31/07/2020 |
Invicorp | injektionsvæske, opløsning; | 25 mikrogram+2 mg | Aviptadil, Phentolaminmesilat | 21/02/2020 |
Ipinzan | filmovertrukne tabletter; | 50+1000 mg | METFORMINHYDROCHLORID, Vildagliptin | 20/10/2021 |
Ipinzan | filmovertrukne tabletter; | 50+850 mg | METFORMINHYDROCHLORID, Vildagliptin | 20/10/2021 |
Ipratropium/salbutamol "Orion" | inhalationsvæske til nebulisator, opløsning, enkeltdosisbeholder; | 0,5+2,5 mg/beholder | IPRATROPIUMBROMID, SALBUTAMOLSULFAT | 10/09/2014 |
Ipratropiumbromid/Salbutamol "Neutec" | inhalationsvæske til nebulisator, opløsning; | 0,5+2,5 mg | IPRATROPIUMBROMIDMONOHYDRAT, SALBUTAMOLSULFAT | 11/05/2023 |