EMA/PE/0000227737 - paediatric investigation plan

Galcanezumab

Key facts

• Invented name:
  Emgality
• Active substance:
  Galcanezumab
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000227737
• PIP number:
  EMA/PE/0000227737
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of migraine headaches
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/06/2025
• Compliance check done:
  Nie

Decision

EMA/PE/0000227737 : EMA decision of 12 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for galcanezumab (Emgality)

Adopted Reference Number: EMADOC-1700519818-2187667