Tolvaptan Accord



This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 14/08/2023

Authorisation details

Product details
Tolvaptan Accord
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Inappropriate ADH Syndrome
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona

Product information

24/03/2023 Tolvaptan Accord - EMEA/H/C/005961 - EMEA/H/C/005961

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Assessment history

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