Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Cerdelga 21 mg hard capsules.
Cerdelga 84 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Cerdelga 21 mg hard capsule: Capsule with a pearl white opaque cap and pearl white opaque body with “GZ04” printed in black on the capsule. The size of the capsule is ‘size 4’ (dimensions 14 × 5 mm). Cerdelga 84 mg 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 × 6.4 mm). |
Each capsule contains 21 mg of eliglustat (as tartrate).
Excipient with known effect: Each capsule contains 27 mg of lactose (as monohydrate).
Each capsule contains 84.4 mg of eliglustat (as tartrate).
Excipient with known effect: Each capsule contains 106 mg of 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. SRT aims to reduce the rate of synthesis of the major substrate glucosylceramide (GL-1) to match its impaired rate of catabolism in patients with GD1, thereby preventing glucosylceramide accumulation and alleviating clinical manifestations. |
| 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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.