Cerdelga (eliglustat)
- Region
- 🇪🇺 EU
- Active substance
- eliglustat
- Company
- Sanofi B.V.
- Status
- Authorised
- Therapeutic area
- Gaucher Disease
- CHMP opinion
- Thu 20 Nov 2014
- EU approval
- Mon 19 Jan 2015
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/003724
- ATC
- A16AX10
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.