MHRA-101094-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • GIVINOSTAT HYDROCHLORIDE MONOHYDRATE
Invented Name
  • Duvyzat
  • Duvyzat 8.86 mg/ml oral suspension
PIP Number MHRA-101094-PIP01-23-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral suspension
Therapeutic area
  • Neurology
  • Other: Other drugs for disorders of the musculo-skeletal system
Conditions / Indications
Conditions / Indications:
  • Treatment of Duchenne muscular dystrophy
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):GIVINOSTAT HYDROCHLORIDE MONOHYDRATE.pdf
Published Date 04/03/2026