EMEA-000461-PIP02-11-M05 - paediatric investigation plan

Eliglustat (tartrate)

Key facts

• Invented name:
  Cerdelga
• Active substance:
  Eliglustat (tartrate)
• Therapeutic area:
  Other
• Decision number:
  P/0440/2022
• PIP number:
  EMEA-000461-PIP02-11-M05
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of Gaucher disease Type 1 and Type 3
  • Treatment of Gaucher disease, type 2
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000461-PIP02-11-M05
• Compliance opinion date:
  10/11/2023
• Compliance outcome:
  Positive

Decision

P/0440/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eliglustat (Cerdelga) (EMEA-000461-PIP02-11-M05)

Adopted Reference Number: EMA/808128/2022