EMEA-001194-PIP01-11-M04

Key facts

Invented name
Galafold
Active substance
Migalastat (hydrochloride)
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0137/2019
PIP number
EMEA-001194-PIP01-11-M04
Pharmaceutical form(s)
  • Capsule
  • hard
  • Dispersible tablet
Condition(s) / indication(s)
Treatment of Fabry disease
Route(s) of administration
Oral use
Contact for public enquiries
Amicus Therapeutics UK Limited

Tel.  +1 6096625044
E-mail: spellegrino@amicusrx.com

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

Decision

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