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||
22/12/2020 Samsca - EMEA/H/C/000980 - IB/0042
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).