EMEA-001860-PIP03-16-M08 - paediatric investigation plan

Galcanezumab

Key facts

• Invented name:
  Emgality
• Active substance:
  Galcanezumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0030/2023
• PIP number:
  EMEA-001860-PIP03-16-M08
• 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:
  31/01/2023
• Compliance check done:
  No

Decision

P/0030/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for galcanezumab (Emgality), (EMEA-001860-PIP03-16-M08)

Reference Number: EMA/21183/2023