MHRA-100369-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • MIGALASTAT HYDROCHLORIDE
Invented Name
  • Galafold
  • Galafold
  • Galafold 123 mg capsules
PIP Number MHRA-100369-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Oral solution
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of Fabry disease
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Amicus Therapeutics UK Ltd
  • Country United Kingdom
  • Tel +16096623809
  • Email ir@amicusrx.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MIGALASTAT HYDROCHLORIDE.pdf
Published Date 02/02/2023