EMEA-002095-PIP01-16-M01 - paediatric investigation plan

lucerastat

Key facts

• Active substance:
  lucerastat
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0221/2020
• PIP number:
  EMEA-002095-PIP01-16-M01
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of Fabry disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/06/2020
• Compliance check done:
  No

Decision

P/0221/2020: EMA decision of 17 June 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lucerastat (EMEA-002095-PIP01-16-M01)

Adopted Reference Number: EMA/257780/2020