MHRA-100878-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • VIBEGRON
Invented Name
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
PIP Number MHRA-100878-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Granules
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of myoneurogenic bladder disorders
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):VIBEGRON.pdf
Published Date 14/07/2025