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EMA Product

Samsca

Product approved by European Medicines Agency (EU)

Basic Information

Samsca

Regulatory Information

EMEA/H/C/000980

Authorised

August 2, 2009

May 28, 2009

16

July 1, 2022

Company Information

Netherlands

Herikerbergweg 292 1101 CT Amsterdam

Otsuka Pharmaceutical Netherlands B.V.

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).

Overview Summary

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.

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