Samsca
tolvaptan
Table of contents
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.
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 |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
02/08/2009
|
Contact address |
Herikerbergweg 292 |
Product information
12/05/2022 Samsca - EMEA/H/C/000980 - II/0046/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
Diuretics
Therapeutic indication
Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).