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 "Orion" filmovertrukne tabletter; 245 mg TENOFOVIRDISOPROXILFUMARAT 05/04/2019
Tenofovir disoproxil "Stada" filmovertrukne tabletter; 245 mg Tenofovirdisoproxil-succinat 16/08/2019
Tenofovir disoproxil "Teva" filmovertrukne tabletter; 245 mg Tenofovir disoproxilphosphat 14/07/2015
Tenofovirdisoproxil "Accord" filmovertrukne tabletter; 245 mg Tenofovirdisoproxil 13/09/2019
Terlipressinacetat "SUN" injektionsvæske, opløsning; 1 mg Terlipressinacetat 10/01/2017
Testavan transdermal gel; 20 mg/g TESTOSTERON 15/02/2018
Tetridar injektionsvæske, opløsning i fyldt pen; 20 mikrog/80 mikroL TERIPARATIDACETAT 14/12/2017
Thalidomid "Accord" kapsler, hårde; 50 mg THALIDOMID 08/10/2019
Thiamazole "Uni-Pharma" tabletter; 5 mg THIAMAZOL 08/03/2017

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