MHRA-101094-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Givinostat
Invented Name
Not yet available
PIP Number MHRA-101094-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral suspension
Therapeutic area
Therapeutic area:
  • Neurology
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
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
02/02/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101094-PIP01-23 -C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Givinostat .pdf
Published Date 30/04/2024