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
Tacrolimus "Accord" salve; 0,1 % Tacrolimusmonohydrat 25/10/2017
Tadalafil "Accord" filmovertrukne tabletter; 10 mg TADALAFIL 08/04/2016
Tadalafil "Accord" filmovertrukne tabletter; 2,5 mg TADALAFIL 08/04/2016
Tadalafil "Accord" filmovertrukne tabletter; 20 mg TADALAFIL 08/04/2016
Tadalafil "Accord" filmovertrukne tabletter; 5 mg TADALAFIL 08/04/2016
Tadalafil "AOP" filmovertrukne tabletter; 20 mg TADALAFIL 29/01/2019
Tadalafil "Farmaprojects" filmovertrukne tabletter; 10 mg TADALAFIL 26/01/2017
Tadalafil "Farmaprojects" filmovertrukne tabletter; 2,5 mg TADALAFIL 26/01/2017
Tadalafil "Farmaprojects" filmovertrukne tabletter; 20 mg TADALAFIL 26/01/2017
Tadalafil "Farmaprojects" filmovertrukne tabletter; 5 mg TADALAFIL 26/01/2017
Tadalafil "Krka" filmovertrukne tabletter; 10 mg TADALAFIL 21/01/2017
Tadalafil "Krka" filmovertrukne tabletter; 2,5 mg TADALAFIL 21/01/2017
Tadalafil "Krka" filmovertrukne tabletter; 20 mg TADALAFIL 21/01/2017
Tadalafil "Krka" filmovertrukne tabletter; 5 mg TADALAFIL 21/01/2017
Tadalafil "Orion" filmovertrukne tabletter; 10 mg TADALAFIL 13/01/2016
Tadalafil "Orion" filmovertrukne tabletter; 20 mg TADALAFIL 13/01/2016
Tadalafil "Orion" filmovertrukne tabletter; 5 mg TADALAFIL 13/01/2016
Tadalafil "Sandoz" filmovertrukne tabletter; 10 mg TADALAFIL 10/11/2016
Tadalafil "Sandoz" filmovertrukne tabletter; 2,5 mg TADALAFIL 10/11/2016
Tadalafil "Sandoz" filmovertrukne tabletter; 20 mg TADALAFIL 10/11/2016
Tadalafil "Sandoz" filmovertrukne tabletter; 5 mg TADALAFIL 10/11/2016
Tadalafil "Stada" filmovertrukne tabletter; 10 mg TADALAFIL 25/10/2016
Tadalafil "Stada" filmovertrukne tabletter; 20 mg TADALAFIL 25/10/2016
Tadalafil "Stada" filmovertrukne tabletter; 5 mg TADALAFIL 25/10/2016
Tadalafil "Teva" filmovertrukne tabletter; 10 mg TADALAFIL 29/04/2015
Tadalafil "Teva" filmovertrukne tabletter; 2,5 mg TADALAFIL 29/04/2015
Tadalafil "Teva" filmovertrukne tabletter; 20 mg TADALAFIL 29/04/2015
Tadalafil "Teva" filmovertrukne tabletter; 5 mg TADALAFIL 29/04/2015
Taflotan øjendråber, opløsning, enkeltdosisbeholder; 15 mikrogram/ml Tafluprost 14/03/2019
Taflotan øjendråber, opløsning; 15 mikrogram/ml Tafluprost 30/07/2018
Takrozem salve; 0,1 % Tacrolimusmonohydrat 25/10/2017
Tamsulosin "Krka" kapsler med modificeret udløsning, hårde; 0,4 mg TAMSULOSINHYDROCHLORID 03/06/2019
Tanafra øjendråber, opløsning; 50 mikrogram/ml LATANOPROST 24/05/2018
Tapin medicinsk plaster; 25+25 mg LIDOCAIN, PRILOCAIN 04/06/2014
Taptiqom øjendråber, opløsning, enkeltdosisbeholder; 15 mikg/ml+5 mg/ml Tafluprost, TIMOLOLMALEAT 02/10/2014
Targin depottabletter; 10+5 mg NALOXONHYDROCHLORIDDIHYDRAT, OXYCODONHYDROCHLORID 14/07/2016
Targin depottabletter; 15+7,5 mg NALOXONHYDROCHLORIDDIHYDRAT, OXYCODONHYDROCHLORID 14/07/2016
Targin depottabletter; 20+10 mg NALOXONHYDROCHLORIDDIHYDRAT, OXYCODONHYDROCHLORID 14/07/2016
Targin depottabletter; 30+15 mg NALOXONHYDROCHLORIDDIHYDRAT, OXYCODONHYDROCHLORID 14/07/2016
Targin depottabletter; 40+20 mg NALOXONHYDROCHLORIDDIHYDRAT, OXYCODONHYDROCHLORID 14/07/2016
Targin depottabletter; 5+2,5 mg NALOXONHYDROCHLORIDDIHYDRAT, OXYCODONHYDROCHLORID 14/07/2016
Targocid pulver til injektions-/infusionsvæske, opløsning eller oral opløsning; 200 mg TEICOPLANIN 09/01/2015
Targocid pulver til injektions-/infusionsvæske, opløsning eller oral opløsning; 400 mg TEICOPLANIN 09/01/2015
Tasdurit kapsler, bløde; 0,5 mg DUTASTERID 18/04/2016

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