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 |
Tektrotyd | radiofarmaceutisk præparationssæt; | 20 mikrogram | HYNIC-[D-Phe1,Tyr3-Octreotide] trifluoroacetat | 24/05/2016 |
Telmisartan/hydrochlorthiazid "Krka" | tabletter; | 40+12,5 mg | HYDROCHLORTHIAZID, TELMISARTAN | 03/07/2015 |
Tenofovir disoproxil "Accordpharma" | filmovertrukne tabletter; | 245 mg | TENOFOVIRDISOPROXILFUMARAT | 15/09/2019 |
Tenofovir disoproxil "Glenmark" | filmovertrukne tabletter; | 245 mg | Tenofovir disoproxilphosphat | 20/06/2018 |
Tenofovir disoproxil "Stada" | filmovertrukne tabletter; | 245 mg | Tenofovirdisoproxil-succinat | 16/08/2019 |
Tenofovir disoproxil "Teva" | filmovertrukne tabletter; | 245 mg | Tenofovir disoproxilphosphat | 14/07/2015 |
Tenofovir disoproxil "Zentiva k.s." | filmovertrukne tabletter; | 245 mg | TENOFOVIRDISOPROXILFUMARAT | 19/04/2024 |
Terbinafin "Moberg Pharma" | kutanopløsning; | 98 mg/ml | TERBINAFINHYDROCHLORID | 27/06/2023 |
Terbinafin "Sandoz" | medicinsk neglelak; | 78,22 mg/ml | TERBINAFINHYDROCHLORID | 16/09/2020 |
Terclara | kutanopløsning; | 98 mg/ml | TERBINAFINHYDROCHLORID | 27/06/2023 |
Teriflunomid "Zentiva" | filmovertrukne tabletter; | 14 mg | Teriflunomid | 05/01/2023 |
Teriflunomide "Glenmark" | filmovertrukne tabletter; | 14 mg | Teriflunomid | 02/02/2024 |
Teriflunomide "Krka" | filmovertrukne tabletter; | 14 mg | Teriflunomid | 23/11/2022 |
Teriflunomide "Newbury" | filmovertrukne tabletter; | 14 mg | Teriflunomid | 21/09/2022 |
Teriflunomide "Orion" | filmovertrukne tabletter; | 14 mg | Teriflunomid | 09/11/2022 |
Teriflunomide "Sandoz" | filmovertrukne tabletter; | 14 mg | Teriflunomid | 05/10/2022 |
Teriflunomide "Stada" | filmovertrukne tabletter; | 14 mg | Teriflunomid | 21/09/2022 |
Teriflunomide "Vivanta" | filmovertrukne tabletter; | 14 mg | Teriflunomid | 18/01/2023 |
Terlipressinacetat "SUN" | injektionsvæske, opløsning; | 1 mg | Terlipressinacetat | 10/01/2017 |
Testavan | transdermal gel; | 20 mg/g | TESTOSTERON | 15/02/2018 |
Testogel | transdermal gel; | 16,2 mg/g | TESTOSTERON | 28/06/2022 |
Testogel | transdermal gel i brev; | 40,5 mg | TESTOSTERON | 01/06/2021 |
Testonur | injektionsvæske, opløsning; | 1000 mg/4 ml | TESTOSTERONUNDECANOAT | 21/04/2024 |
Testosteron "Medical Valley" | injektionsvæske, opløsning; | 1000 mg/4 ml | TESTOSTERONUNDECANOAT | 07/12/2022 |
Testosterone "Teva" | injektionsvæske, opløsning; | 1000 mg/4 ml | TESTOSTERONUNDECANOAT | 07/12/2022 |
Tetravac | injektionsvæske, suspension; | Bordetella pertussis, filamentøs hæmagglutinin (FHA), Bordetella pertussis, toxoid, Clostridium tetani, stamme Harvard 49205, toxoid, Corynebacterium diphtheria, stamme Utrecht CN 2000 MSM III, toxoid, Poliovirus type 1, stamme Mahoney (inaktiveret), Poliovirus type 2, stamme MEF-1 (inaktiveret), Poliovirus type 3, stamme Saukett (inaktiveret) | 01/07/2021 | |
Tetridar | injektionsvæske, opløsning i fyldt pen; | 20 mikrog/80 mikroL | TERIPARATIDACETAT | 14/12/2017 |
Thalidomid "Accord" | kapsler, hårde; | 50 mg | THALIDOMID | 08/10/2019 |
Thalidomide "Zentiva" | kapsler, hårde; | 50 mg | THALIDOMID | 20/05/2024 |
Thiamazole "Uni-Pharma" | tabletter; | 5 mg | THIAMAZOL | 08/03/2017 |
Thiamine "Sterop" | injektionsvæske, opløsning; | 125 mg/ml | Thiaminhydrochlorid | 16/01/2022 |
Thiamine "Sterop" | injektionsvæske, opløsning; | 50 mg/ml | Thiaminhydrochlorid | 16/01/2022 |
Thiopental "Panpharma" | pulver til injektionsvæske, opløsning; | 0,5 g | Thiopentalnatrium og natriumcarbonat | 29/04/2022 |
Thiopental "Panpharma" | pulver til injektionsvæske, opløsning; | 1 g | Thiopentalnatrium og natriumcarbonat | 29/04/2022 |
Thiotepa "Abcur" | pulver til koncentrat til infusionsvæske, opløsning; | 100 mg | THIOTEPA | 28/06/2023 |
Thiotepa "Abcur" | pulver til koncentrat til infusionsvæske, opløsning; | 15 mg | THIOTEPA | 28/06/2023 |
Thiotepa "Fresenius Kabi" | pulver til koncentrat til infusionsvæske, opløsning; | 100 mg | THIOTEPA | 02/03/2023 |
Thiotepa "Fresenius Kabi" | pulver til koncentrat til infusionsvæske, opløsning; | 15 mg | THIOTEPA | 02/03/2023 |
Thiotepa "Medac" | pulver til koncentrat til infusionsvæske, opløsning; | 100 mg | THIOTEPA | 20/01/2023 |
Thiotepa "Medac" | pulver til koncentrat til infusionsvæske, opløsning; | 15 mg | THIOTEPA | 20/01/2023 |