EMEA-000551-PIP04-21-M02 - paediatric investigation plan

Givinostat

Key facts

• Active Substance:
  Givinostat
• Therapeutic area:
  Neurology
• Decision number:
  P/0240/2023
• PIP number:
  EMEA-000551-PIP04-21-M02
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of Duchenne muscular dystrophy
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Italfarmaco S.p.A.

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0240/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for givinostat (EMEA-000551-PIP04-21-M02)

Reference Number: EMA/264176/2023