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 |
Trabectedin "Teva" | pulver til koncentrat til infusionsvæske, opløsning; | 0,25 mg | Trabectedin | 07/01/2022 |
Trabectedin "Teva" | pulver til koncentrat til infusionsvæske, opløsning; | 1 mg | Trabectedin | 07/01/2022 |
Trabektedin "Sun" | pulver til koncentrat til infusionsvæske, opløsning; | 0,25 mg | Trabectedin | 27/10/2022 |
Trabektedin "Sun" | pulver til koncentrat til infusionsvæske, opløsning; | 1 mg | Trabectedin | 27/10/2022 |
Tracafour | filmovertrukne tabletter; | 500 mg | TRANEXAMSYRE | 24/04/2017 |
Traglafka | øjendråber, opløsning; | 40 mikrogram/ml | Travoprost | 07/07/2021 |
Tramadol "Krka" | depottabletter; | 100 mg | TRAMADOLHYDROCHLORID | 05/10/2018 |
Tramadol "Krka" | depottabletter; | 150 mg | TRAMADOLHYDROCHLORID | 05/10/2018 |
Tramadol "Krka" | depottabletter; | 200 mg | TRAMADOLHYDROCHLORID | 05/10/2018 |
Tramadol "Krka" | kapsler, hårde; | 50 mg | TRAMADOLHYDROCHLORID | 14/12/2017 |
Tranexamic acid "Baxter" | injektions-/infusionsvæske, opløsning; | 100 mg/ml | TRANEXAMSYRE | 22/04/2020 |
Tranexamic acid "Tillomed" | injektionsvæske, opløsning; | 100 mg/ml | TRANEXAMSYRE | 18/08/2023 |
Tranexkabi | infusionsvæske, opløsning; | 10 mg/ml | TRANEXAMSYRE | 08/11/2023 |
Travoprost "Pharmathen" | øjendråber, opløsning; | 40 mikrogram/ml | Travoprost | 03/04/2019 |
Travoprost "Stada" | øjendråber, opløsning; | 40 mikrogram/ml | Travoprost | 13/03/2014 |
Travoprost "Zentiva" | øjendråber, opløsning; | 40 mikrogram/ml | Travoprost | 28/10/2015 |
Travoprost/Timolol "Medical Valley" | øjendråber, opløsning; | 40 mikrog/ml+5 mg/ml | TIMOLOLMALEAT, Travoprost | 25/05/2022 |
Travoprost/Timolol "Stada" | øjendråber, opløsning; | 40 mikrog/ml+5 mg/ml | TIMOLOLMALEAT, Travoprost | 24/05/2017 |
Travoprost/Timolol "Viatris" | øjendråber, opløsning; | 40 mikrog/ml+5 mg/ml | TIMOLOLMALEAT, Travoprost | 24/05/2017 |
Traxidot | injektionsvæske, opløsning; | 100 mg/ml | TRANEXAMSYRE | 13/03/2015 |
Trazodonhydrochlorid "Medical Valley" | filmovertrukne tabletter; | 100 mg | Trazodonhydrochlorid | 23/02/2021 |
Treo Hindbær | brusetabletter; | 500+50 mg | ACETYLSALICYLSYRE, Caffein | 29/11/2019 |
Treosulfan "Tillomed" | pulver til infusionsvæske, opløsning; | 5 g | TREOSULFAN | 11/02/2019 |
Treprostinil "Reddy" | infusionsvæske, opløsning; | 1 mg/ml | Treprostinil | 28/12/2021 |
Treprostinil "Reddy" | infusionsvæske, opløsning; | 10 mg/ml | Treprostinil | 28/12/2021 |
Treprostinil "Reddy" | infusionsvæske, opløsning; | 2,5 mg/ml | Treprostinil | 28/12/2021 |
Treprostinil "Reddy" | infusionsvæske, opløsning; | 5 mg/ml | Treprostinil | 28/12/2021 |
Treprostinil "Tillomed" | infusionsvæske, opløsning; | 1 mg/ml | Treprostinil | 22/02/2022 |
Treprostinil "Tillomed" | infusionsvæske, opløsning; | 10 mg/ml | Treprostinil | 22/02/2022 |
Treprostinil "Tillomed" | infusionsvæske, opløsning; | 2,5 mg/ml | Treprostinil | 22/02/2022 |
Treprostinil "Tillomed" | infusionsvæske, opløsning; | 5 mg/ml | Treprostinil | 22/02/2022 |
Tresuvi | infusionsvæske, opløsning; | 1 mg/ml | Treprostinil | 05/08/2019 |
Tresuvi | infusionsvæske, opløsning; | 10 mg/ml | Treprostinil | 05/08/2019 |
Tresuvi | infusionsvæske, opløsning; | 2,5 mg/ml | Treprostinil | 05/08/2019 |
Tresuvi | infusionsvæske, opløsning; | 5 mg/ml | Treprostinil | 05/08/2019 |
Trexan | tabletter; | 10 mg | METHOTREXATNATRIUM | 03/04/2020 |
Trexan | tabletter; | 2,5 mg | METHOTREXATNATRIUM | 06/07/2016 |
Triaxis | injektionsvæske, suspension, fyldt injektionssprøjte; | Bordetella pertussis, pertactin (PRN/69 kiloDalton ydermembranprotein), Bordetella pertussis, stamme 10536, fimbriae agglutinogener 2 + 3, Bordetella pertussis, toxoid, Difteritoksoid, HAEMAGGLUTININ, FILAMENTØST, TETANUSTOKSOID, RENSET | 02/12/2022 | |
Trica | injektionsvæske, suspension; | 20 mg/ml | TRIAMCINOLONHEXACETONID | 06/07/2016 |
Trientin "Waymade" | kapsler, hårde; | 200 mg | TRIENTINDIHYDROCHLORID | 08/07/2022 |
Trientine "Tillomed" | kapsler, hårde; | 167 mg | TRIENTINDIHYDROCHLORID | 23/12/2019 |
Triplo | tabletter; | 500+50 mg | ACETYLSALICYLSYRE, Caffein | 28/09/2018 |
Triplo | brusetabletter; | 500+50 mg | ACETYLSALICYLSYRE, Caffein | 04/07/2017 |
Triplo Citrus | brusetabletter; | 500+50 mg | ACETYLSALICYLSYRE, Caffein | 04/07/2017 |
True Test 24 | plaster til provokationstest; | Alfa-amylcinnamaldehyd, Almindelig slåenlav (Evernia prunastri), Benzocain, Benzylparahydroxybenzoat, Butylparahydroxybenzoat, Chlorquinaldol, CINCHOCAINHYDROCHLORID, Cinnamaldehyd, Cinnamylalkohol, Clioquinol, Cyclohexylbenzothiazylsulfenamid, Dibenzothiazyldisulfid, Dipentamethylenthiuramdisulfid, Diphenylguanidin, DISULFIRAM, Epoxyresin, Ethylendiamindihydrochlorid, Ethylparahydroxybenzoat, EUGENOL, Geraniol, Hydroxycitronellal, Isoeugenol, Kaliumdichromat, Koboltchlorid, Kolofonium, LANOLINALKOHOL, Mercaptobenzothiazol, Methylchlorisothiazolinon, Methylparahydroxybenzoat, Morpholinylmercaptobenzothiazol, N-Cyclohexyl-N-Phenylparaphenylendiamin, N-Hydroxymethylsuccinimid, N-Isopropyl-N-phenylparaphenylendiamin, N,N-Diphenylparaphenylendiamin, NEOMYCINSULFAT, Nikkelsulfat, P-TERT BUTYLPHENOL FORMALDEHYD HARPIKS, Paraphenylendiamin, Perubalsam, Propylparahydroxybenzoat, Quaternium-15, Tetracainhydrochlorid, Tetramethylthiurammonosulfid, THIOMERSAL, Thiram, ZINKDIBUTYLDITHIOCARBAMAT, ZINKDIETHYLDITHIOCARBAMAT | 03/07/2023 | |
True Test 36 | plaster til provokationstest; | Alfa-amylcinnamaldehyd, Almindelig slåenlav (Evernia prunastri), Bacitracin, Benzocain, Benzylparahydroxybenzoat, BRONOPOL, BUDESONID, Butylparahydroxybenzoat, Cinnamaldehyd, Cinnamylalkohol, Clioquinol, Cyclohexylbenzothiazylsulfenamid, DIAZOLIDINYL UREA, Dibenzothiazyldisulfid, Dipentamethylenthiuramdisulfid, Diphenylguanidin, Disperse blue 106, DISULFIRAM, Epoxyresin, Ethylendiamindihydrochlorid, Ethylparahydroxybenzoat, EUGENOL, Geraniol, Guldnatriumthiosulfat, HYDROCORTISONBUTYRAT, Hydroxycitronellal, IMIDUREA, Isoeugenol, Kaliumdichromat, Koboltchlorid, Kolofonium, LANOLINALKOHOL, Mercaptobenzothiazol, Methylchlorisothiazolinon, Methyldibromoglutharonitrile, Methylparahydroxybenzoat, Morpholinylmercaptobenzothiazol, N-Cyclohexyl-N-Phenylparaphenylendiamin, N-Hydroxymethylsuccinimid, N-Isopropyl-N-phenylparaphenylendiamin, N,N-Diphenylparaphenylendiamin, NEOMYCINSULFAT, Nikkelsulfat, P-TERT BUTYLPHENOL FORMALDEHYD HARPIKS, Paraphenylendiamin, Parthenolid, Perubalsam, Propylparahydroxybenzoat, Quaternium-15, Tetracainhydrochlorid, Tetramethylthiurammonosulfid, THIOMERSAL, Thiram, TIXOCORTOLPIVALAT, ZINKDIBUTYLDITHIOCARBAMAT, ZINKDIETHYLDITHIOCARBAMAT | 19/03/2020 | |
Tutecvi Combi | filmovertrukne tabletter; | 50+1000 mg | METFORMINHYDROCHLORID, Vildagliptin | 13/12/2021 |
Tutecvi Combi | filmovertrukne tabletter; | 50+850 mg | METFORMINHYDROCHLORID, Vildagliptin | 13/12/2021 |