Basic Information
Tolvaptan Accord
Regulatory Information
EMEA/H/C/005961
January 26, 2023
August 14, 2023
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf). Tolvaptan Accord contains the active substance tolvaptan.