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
Tracafour filmovertrukne tabletter; 500 mg TRANEXAMSYRE 24/04/2017
Traglafka øjendråber, opløsning; 40 mikrogram/ml Travoprost 03/11/2016
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
Tramadolhydrochlorid/Paracetamol "Bristol Lab." filmovertrukne tabletter; 37,5+325 mg PARACETAMOL, TRAMADOLHYDROCHLORID 05/02/2015
Tramadolhydrochlorid/Paracetamol "Orion" filmovertrukne tabletter; 37,5+325 mg PARACETAMOL, TRAMADOLHYDROCHLORID 15/06/2018
Tranexamic acid "Baxter" injektions-/infusionsvæske, opløsning; 100 mg/ml TRANEXAMSYRE 22/04/2020
Tranexamsyre "Accord" injektionsvæske, opløsning; 100 mg/ml TRANEXAMSYRE 24/10/2016
Tranexamsyre "Alternova" injektionsvæske, opløsning, i.v.; 100 mg/ml TRANEXAMSYRE 25/06/2014
Tranexamsyre "Life" injektionsvæske, opløsning, i.v.; 100 mg/ml TRANEXAMSYRE 20/03/2015
Travoprost "Pharmathen International" øjendråber, opløsning; 30 mikrogram/ml Travoprost 20/09/2017
Travoprost "Pharmathen" øjendråber, opløsning; 40 mikrogram/ml Travoprost 03/04/2019
Travoprost "Sandoz" øjendråber, opløsning; 40 mikrogram/ml Travoprost 06/03/2017
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 12/04/2018
Travoprost/Timolol "Mylan" øjendråber, opløsning; 40 mikrog/ml+5 mg/ml TIMOLOLMALEAT, Travoprost 24/05/2017
Travoprost/Timolol "Omnivision" øjendråber, opløsning; 40 mikrg/ml+5 mg/ml TIMOLOLMALEAT, Travoprost 24/05/2017
Travoprost/Timolol "Stada" øjendråber, opløsning; 40 mikrog/ml+5 mg/ml TIMOLOLMALEAT, Travoprost 24/05/2017
Traxidot injektionsvæske, opløsning; 100 mg/ml TRANEXAMSYRE 13/03/2015
Treo Hindbær brusetabletter; 500+50 mg ACETYLSALICYLSYRE, Caffein 29/11/2019
Treosulfan "Tillomed" pulver til infusionsvæske, opløsning; 5 g TREOSULFAN 11/02/2019
Tresuvi infusionsvæske, opløsning; 1 mg/ml Treprostinilnatrium 05/08/2019
Tresuvi infusionsvæske, opløsning; 10 mg/ml Treprostinilnatrium 05/08/2019
Tresuvi infusionsvæske, opløsning; 2,5 mg/ml Treprostinilnatrium 05/08/2019
Tresuvi infusionsvæske, opløsning; 5 mg/ml Treprostinilnatrium 05/08/2019
Trexan tabletter; 10 mg METHOTREXATNATRIUM 03/04/2020
Trexan tabletter; 2,5 mg METHOTREXATNATRIUM 06/07/2016
Triamcinolonacetonid "sanofi-aventis" næsespray, suspension; 55 mikrogram/dosis TRIAMCINOLONACETONID 17/03/2016
Trica injektionsvæske, suspension; 20 mg/ml TRIAMCINOLONHEXACETONID 06/07/2016
Trientine "Tillomed" kapsler, hårde; 167 mg TRIENTINDIHYDROCHLORID 23/12/2019
Triolif Honey & Lemon sugetabletter; 2+0,60+1,20 mg Amylmetacresol, DICHLORBENZYLALKOHOL, LIDOCAINHYDROCHLORID 11/02/2015
Triolif Mint sugetabletter; 2+0,60+1,20 mg Amylmetacresol, DICHLORBENZYLALKOHOL, LIDOCAINHYDROCHLORID 11/02/2015
Triolif Orange sugetabletter; 2+0,60+1,20 mg Amylmetacresol, DICHLORBENZYLALKOHOL, LIDOCAINHYDROCHLORID 11/02/2015
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
Tritilz tabletter; 10 mg EZETIMIB 07/02/2019
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 18/11/2014
True Test 36 plaster til provokationstest; Alfa-amylcinnamaldehyd, Bacitracin, Benzocain, Benzylparahydroxybenzoat, BRONOPOL, BUDESONID, Butylparahydroxybenzoat, Chlorquinaldol, CINCHOCAINHYDROCHLORID, Cinnamaldehyd, Cinnamylalkohol, Clioquinol, Cyclohexylbenzothiazylsulfenamid, DIAZOLIDINYL UREA, Dibenzothiazyldisulfid, Dipentamethylenthiuramdisulfid, Diphenylguanidin, DISULFIRAM, Epoxyresin, Ethylendiamindihydrochlorid, Ethylparahydroxybenzoat, EUGENOL, Geraniol, Guldsodiumthiosulphate, HYDROCORTISONBUTYRAT, Hydroxycitronellal, IMIDAZOLIDINYL UREA, 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 10/07/2019

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