Basic Information
C03XA01
tolvaptan
Diuretics
Therapeutic indication
Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Overview Summary
Tolvaptan Accord is a medicine for treating abnormally low levels of sodium in the blood in adults with a condition called ‘syndrome of inappropriate antidiuretic hormone secretion’ (SIADH).
In people with SIADH, an excessive amount of the hormone vasopressin makes them produce less urine and thereby retain more water in the body, which dilutes the concentration of sodium in the blood.
Tolvaptan Accord is a ‘generic medicine’. This means that Tolvaptan Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Tolvaptan Accord is called Samsca. For more information on generic medicines, see the question-and-answer document here.
Tolvaptan Accord contains the active substance tolvaptan.
Active Substances (1)
Tolvaptan
Documents (6)
Tolvaptan Accord : EPAR - Public Assessment Report
August 14, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Tolvaptan Accord : EPAR - Medicine overview
August 14, 2023
OVERVIEW_DOCUMENT
Tolvaptan Accord : EPAR - All Authorised presentations
August 14, 2023
AUTHORISED_PRESENTATIONS
CHMP summary of positive opinion for Tolvaptan Accord
January 27, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Tolvaptan Accord : EPAR - Product information
August 14, 2023
DRUG_PRODUCT_INFORMATION
Tolvaptan Accord : EPAR - Risk Management Plan summary
August 14, 2023
RISK_MANAGEMENT_PLAN_SUMMARY
Overview Q&A (7)
Question
Why is Tolvaptan Accord authorised in the EU?
Answer
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.
Question
How does Tolvaptan Accord work?
Answer
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.
Question
How is Tolvaptan Accord used?
Answer
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.
Question
What are the benefits and risks of Tolvaptan Accord?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of Tolvaptan Accord?
Answer
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.
Question
Other information about Tolvaptan Accord
Answer
Tolvaptan Accord received a marketing authorisation valid throughout the EU on 24 March 2023.
This overview was last updated in March 2023.
Question
How has Tolvaptan Accord been studied?
Answer
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.