EMEA-001231-PIP02-13-M05

Key facts

Invented name
Samsca and associated names
Active substance
Tolvaptan
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0347/2017
PIP number
EMEA-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 administration
Oral use
Contact for public enquiries
Otsuka Pharmaceutical Europe Ltd
Tel. +49 6995 5044 321
E-mail: paediatric-info@otsuka-europe.com
Decision type
RPM: decision refers to a refusal on the application for modification of an agreed PIP

Decision

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