EMEA-001556-PIP02-24 - paediatric investigation plan

aldesleukin

Key facts

• Active substance:
  aldesleukin
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0333/2024
• PIP number:
  EMEA-001556-PIP02-24
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0333/2024 : EMA decision of 13 September 2024 on the granting of a product specific waiver for aldesleukin, (EMEA-001556-PIP02-24)

Adopted Reference Number: EMA/413962/2024