EMEA-001194-PIP01-11-M05

Key facts

Invented name
Galafold
Active substance
Migalastat hydrochloride
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/0126/2022
PIP number
EMEA-001194-PIP01-11-M05
Pharmaceutical form(s)
  • Capsule, hard
  • Oral solution
Condition(s) / indication(s)
Treatment of Fabry disease
Route(s) of administration
Oral use
Contact for public enquiries
Amicus Therapeutics Europe Limited

E-mail: IR@amicusrx.com
Tel: +1 6096623809

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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