Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Piramal Critical Care Limited, Suite 4, Ground Floor, Heathrow Boulevard East Wing, 280 Bath Road, West Drayton, UB7 0DQ, United Kingdom
Yargesa 100 mg hard capsules.
| Pharmaceutical Form |
|---|
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Hard capsule. The hard capsule consists of an opaque white cap and body with “708” printed in black on the body. Capsule Size: 4 (14.3 mm x 5.3 mm). |
Each hard capsule contains 100 mg 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 content: Sodium starch glycolate (Type A) Capsule shell: Gelatin Printing ink: Shellac glaze |
PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil containing 21 capsules.
Pack size: 84 × 1 capsules.
Piramal Critical Care Limited, Suite 4, Ground Floor, Heathrow Boulevard – East Wing, 280 Bath Road, West Drayton, UB7 0DQ, United Kingdom
PLGB 37071/0038
01/05/2021
| Drug | Countries | |
|---|---|---|
| YARGESA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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