MHRA-100646-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • TOLVAPTAN
Invented Name
  • Samsca
  • Jinarc
  • Samsca
  • Jinarc
PIP Number MHRA-100646-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Tablet
  • Oral suspension
Therapeutic area
  • Uro-Nephrology
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
  • Treatment of dilutional hyponatraemia
  • Treatment of polycystic kidney disease
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TOLVAPTAN.pdf
Published Date 25/05/2023