Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Amicus Therapeutics Europe Limited, Block 1, Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland Tel: +353 (0) 1 588 6850, Fax: +353 (0) 1 588 6851, e-mail: info@amicusrx.co.uk ...
Galafold 123 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Size 2 hard capsule (6.4x18.0 mm) with an opaque blue cap and opaque white body with “A1001” printed in black, containing white to pale brown powder. |
Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Migalastat |
Migalastat is a pharmacological chaperone that is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of α-Gal A, the genotypes of which are referred to as amenable mutations. Migalastat binding stabilizes these mutant forms of α-Gal A in the endoplasmic reticulum and facilitates their proper trafficking to lysosomes. |
| List of Excipients |
|---|
|
Capsule contents: Pregelatinised starch (maize) Capsule shell: Gelatin Printing ink: Shellac |
PVC / PCTFE / PVC/Al blister.
Pack size of 14 capsules.
Amicus Therapeutics Europe Limited, Block 1, Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland
Tel: +353 (0) 1 588 6850, Fax: +353 (0) 1 588 6851, e-mail: info@amicusrx.co.uk
EU/1/15/1082/001
26 May 2016
| Drug | Countries | |
|---|---|---|
| GALAFOLD | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States |
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