Cerdelga
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Eliglustat
- Made by
- Sanofi B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- AdultsCerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).Paediatric population (from 6 to < 18 years of age) weighing ≥ 15 kgCerdelga is indicated for paediatric patients with GD1 who are 6 years and older with a minimum body weight of 15 kg, who are stable on enzyme replacement therapy (ERT), and who are CYP2D6 PMs, IMs or EMs.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (Cerdelga). It describes the substance, not this exact product.
Gaucher disease is caused by a deficiency of the lysosomal enzyme acid β-glucosidase.
Acid β-glucosidase catalyzes the conversion of the sphingolipid glucocerebroside into glucose and ceramide.
CERDELGA is primarily metabolized by CYP2D6 and to a lesser extent by CYP3A4.
After oral administration of radiolabeled eliglustat, the majority of the administered dose is excreted in urine (42%) and feces (51%), mainly as metabolites.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-03-03
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Sanofi B.V. |
|---|---|
| Active substance | Eliglustat |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A16AX10 · Digestion, stomach, diabetes and nutrition |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2015-01-19 |
| Last updated by the regulator | 2026-07-27 |
| EMA product number | EMEA/H/C/003724 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).