Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Amicus Therapeutics Europe Limited, Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin, D15 AKK1, Ireland e-mail: info@amicusrx.co.uk
Opfolda 65 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Size 2 hard capsule (6.35x18.0 mm) with a grey opaque cap and white opaque body with “AT2221” printed in black on the body, containing white to off-white powder. |
Each hard capsule contains 65 mg of miglustat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Miglustat |
Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids, and a pharmacokinetic enzyme stabiliser of cipaglucosidase alfa. Miglustat is indicated for the treatment of adult patients with mild to moderate type 1 Gaucher disease and for the treatment of progressive neurological manifestations in patients with Niemann-Pick type C disease. Also, miglustat must be used in combination with cipaglucosidase alfa for long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency). |
| List of Excipients |
|---|
|
Capsule contents: Pregelatinised starch (maize) Capsule shell: Gelatin Edible printing ink: Black iron oxide (E172) |
40 mL high density polyethylene (HDPE) bottle with 33 mm white child resistant polypropylene cap with label. Bottle opening is sealed with an induction sealed foil liner.
Bottles of 4 and 24 capsules.
Not all pack sizes may be marketed.
Amicus Therapeutics Europe Limited, Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin, D15 AKK1, Ireland
e-mail: info@amicusrx.co.uk
EU/1/23/1737/001
EU/1/23/1737/002
| Drug | Countries | |
|---|---|---|
| OPFOLDA | Austria, Spain, France, Croatia, Ireland, Italy, Lithuania, United Kingdom |
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