Samsca 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 SIADH, an excessive amount of the hormone vasopressin makes the patient produce less urine and thereby retain more water in the body, which dilutes the concentration of sodium in the blood.
Samsca contains the active substance tolvaptan.
Samsca : EPAR - Medicine overview (PDF/79.42 KB)
First published: 18/08/2009
Last updated: 07/08/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Inappropriate ADH Syndrome
|Anatomical therapeutic chemical (ATC) code||
Otsuka Pharmaceutical Netherlands B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
12/05/2022 Samsca - EMEA/H/C/000980 - II/0046/G
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).