Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Cerdelga 84 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Capsule with pearl blue-green opaque cap and pearl white opaque body with “GZ02” printed in black on the body of the capsule. The size of the capsule is ‘size 2’ (dimensions 18.0 × 6.4 mm). |
Each capsule contains 84.4 mg of eliglustat (as tartrate).
Excipient(s) with known effect: Each capsule contains 106 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eliglustat |
Eliglustat is a potent and specific inhibitor of glucosylceramide synthase, and acts as a substrate reduction therapy (SRT) for GD1. |
| List of Excipients |
|---|
|
Capsule contents: Microcrystalline cellulose Capsule shell: Gelatin Printing ink: Shellac |
PETG/COC.PETG/PCTFE-aluminium blister.
Each blister wallets contains 14 hard capsules.
Each pack contains 14, 56 or 196 hard capsules.
Not all pack sizes may be marketed.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
EU/1/14/974/001 56 capsules
EU/1/14/974/002 196 capsules
EU/1/14/974/003 14 capsules
Date of first authorisation: 19 January 2015
| Drug | Countries | |
|---|---|---|
| CERDELGA | Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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