Samsca

RSS

tolvaptan

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 09/11/2018

Authorisation details

Product details
Name
Samsca
Agency product number
EMEA/H/C/000980
Active substance
Tolvaptan
International non-proprietary name (INN) or common name
tolvaptan
Therapeutic area (MeSH)
Inappropriate ADH Syndrome
Anatomical therapeutic chemical (ATC) code
C03XA01
Publication details
Marketing-authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
02/08/2009
Contact address

Herikerbergweg 292
1101 CT Amsterdam
Netherlands

Product information

31/10/2018 Samsca - EMEA/H/C/000980 - T/0036

Contents

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Pharmacotherapeutic group

Diuretics

Therapeutic indication

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

Assessment history

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