Tolvaptan Accord

Tolvaptan Accord is given once a day as a tablet. The medicine can only be obtained with a prescription. Treatment should be started in hospital so that healthcare professionals can determine the most appropriate dose and monitor the patient’s level of blood sodium and blood volume.

For more information about using Tolvaptan Accord, see the package leaflet or contact your doctor or pharmacist.

People with SIADH have an excessive amount of the hormone vasopressin, leading to decreased urine production and an increased amount of water in the blood. The active substance in this medicine, tolvaptan, is a ‘vasopressin-2 receptor antagonist’. This means that it blocks one type of receptor (target) to which the hormone vasopressin normally attaches itself. By blocking this receptor, Tolvaptan Accord prevents vasopressin’s effect. This increases urine production and decreases the amount of water in the blood, thereby increasing the blood sodium level.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Samsca, and do not need to be repeated for Tolvaptan Accord. 

As for every medicine, the company provided studies on the quality of Tolvaptan Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Tolvaptan Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Tolvaptan Accord has been shown to have comparable quality and to be bioequivalent to Samsca. Therefore, the Agency’s view was that, as for Samsca, the benefits of Tolvaptan Accord outweigh the identified risks and it can be authorised for use in the EU.

and effective use of Tolvaptan Accord have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Tolvaptan Accord are continuously monitored. Suspected side effects reported with Tolvaptan Accord are carefully evaluated and any necessary action taken to protect patients.

Tolvaptan Accord received a marketing authorisation valid throughout the EU on 24 March 2023.

This overview was last updated in March 2023.