GALAFOLD Hard capsule Ref.[9249] Active ingredients: Migalastat

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 ...

Product name and form

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.

Qualitative and quantitative composition

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)
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Indigotine (E132)

Printing ink:

Shellac
Black iron oxide
Potassium hydroxide

Pack sizes and marketing

PVC / PCTFE / PVC/Al blister.

Pack size of 14 capsules.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/15/1082/001

26 May 2016

Drugs

Drug Countries
GALAFOLD Austria, Brazil, Canada, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States

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