EMA/PE/0000223656 - paediatric investigation plan

givinostat

Key facts

• Active substance:
  givinostat
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000223656
• PIP number:
  EMA/PE/0000223656
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of polycythaemia vera
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000223656 : EMA decision of 3 January 2025 on the granting of a product specific waiver for givinostat

Adopted Reference Number: EMADOC-1700519818-1810372