MHRA-100566-PIP01-22-M03 (update)

Key Facts

Active Substance
Active Substance:
  • MIRABEGRON
Invented Name
Not yet available
PIP Number MHRA-100566-PIP01-22-M03 (update)
Pharmaceutical form(s)
  • Prolonged-release tablet
  • Prolonged-release granules for oral suspension
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of neurogenic detrusor overactivity
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):MIRABEGRON.pdf
Published Date 15/08/2024