EMEA-001231-PIP02-13-M05

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Overview

Product details for Samsca and associated names
Invented nameSamsca and associated names
Active substance

Tolvaptan

Decision numberP/0347/2017
PIP numberEMEA-001231-PIP02-13-M05
Pharmaceutical form(s)Tablet; Oral suspension
Condition(s)/indication(s)

Treatment of polycystic kidney disease

Treatment of dilutional hyponatraemia

Route(s) of administrationOral use
PIP applicant

Otsuka Pharmaceutical Europe Ltd
Tel. +49 6995 5044 321
E-mail: paediatric-info@otsuka-europe.com

Decision typeRPM: decision refers to a refusal on the application for modifiction of an agreed PIP

Decision