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
• Contact for public enquiries:

  Sanofi B.V.

  E-mail: [e-mail]; Tel. [phone];

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022

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)

AdoptedReference Number: EMA/808128/2022