EMEA-001194-PIP01-11-M06 - paediatric investigation plan

migalastat hydrochloride

Key facts

• Invented name:
  • Galafold
  • Galafold
• Active substance:
  migalastat hydrochloride
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0172/2023
• PIP number:
  EMEA-001194-PIP01-11-M06
• Pharmaceutical form(s):
  • Capsule, hard
  • Dispersible tablet
• 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:
  15/05/2023
• Compliance check done:
  No

Decision

P/0172/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for migalastat (hydrochloride) (Galafold), (EMEA-001194-PIP01-11-M06)

Adopted Reference Number: EMA/171090/2023