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) |
|
| Condition(s) / indication(s) |
Treatment of Fabry disease
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Amicus Therapeutics Europe Limited
Tel. +1 6096625079 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|