EMEA-003097-PIP01-21 - paediatric investigation plan

corticotropin

Key facts

• Active substance:
  corticotropin
• Therapeutic area:
  Neurology
• Decision number:
  P/0384/2022
• PIP number:
  EMEA-003097-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of infantile spasms
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  23/09/2022
• Compliance check done:
  No

Decision

P/0384/2022 : EMA decision of 23 September 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for corticotropin (EMEA-003097-PIP01-21)

Adopted Reference Number: EMA/678481/2022