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
Tobramycin "SUN" inhalationsvæske til nebulisator, opløsning; 300 mg/5 ml TOBRAMYCIN 21/12/2016
Toctino kapsler, bløde; 10 mg ALITRETINOIN 17/09/2019
Toctino kapsler, bløde; 30 mg ALITRETINOIN 17/09/2019
Tolak creme; 40 mg/g FLUORURACIL 09/10/2019
Tolterodintartrat "Accord" filmovertrukne tabletter; 1 mg TOLTERODINTARTRAT 05/04/2014
Tolterodintartrat "Accord" filmovertrukne tabletter; 2 mg TOLTERODINTARTRAT 05/04/2014
Tolvaptan "Teva" tabletter; 15 mg Tolvaptan 17/03/2020
Tolvaptan "Teva" tabletter; 30 mg Tolvaptan 17/03/2020
Tomonil tabletter; 1,5 mg LEVONORGESTREL 21/05/2019
Topimax filmovertrukne tabletter; 100 mg TOPIRAMAT 14/03/2019
Topimax kapsler, hårde; 15 mg TOPIRAMAT 14/03/2019
Topimax filmovertrukne tabletter; 200 mg TOPIRAMAT 14/03/2019
Topimax filmovertrukne tabletter; 25 mg TOPIRAMAT 14/03/2019
Topimax kapsler, hårde; 25 mg TOPIRAMAT 14/03/2019
Topimax filmovertrukne tabletter; 50 mg TOPIRAMAT 14/03/2019
Topimax kapsler, hårde; 50 mg TOPIRAMAT 14/03/2019
Topiramat "Accord" filmovertrukne tabletter; 100 mg TOPIRAMAT 12/12/2018
Topiramat "Accord" filmovertrukne tabletter; 200 mg TOPIRAMAT 12/12/2018
Topiramat "Accord" filmovertrukne tabletter; 25 mg TOPIRAMAT 12/12/2018
Topiramat "Accord" filmovertrukne tabletter; 50 mg TOPIRAMAT 12/12/2018
Toredin øjendråber, opløsning; 1 mg/ml OLOPATADINHYDROCHLORID 17/02/2020

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.


...