EMEA-001231-PIP02-13-M10 - paediatric investigation plan

Tolvaptan

Key facts

• Invented name:
  Samsca and associated names
• Active Substance:
  Tolvaptan
• Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Uro-nephrology
• Decision number:
  P/0177/2023
• PIP number:
  EMEA-001231-PIP02-13-M10
• Pharmaceutical form(s):
  • Tablet
  • Oral suspension
• Condition(s) / indication(s):
  • Treatment of dilutional hyponatraemia
  • Treatment of polycystic kidney disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Otsuka Pharmaceutical Netherlands B.V.

  [e-mail] ; [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2023

Decision

P/0177/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M10)

AdoptedReference Number: EMA/171114/2023