🇪🇺 Eliglustat GZ385660 in European Union

EMA authorised Eliglustat GZ385660 on 19 January 2015

Marketing authorisation

EMA — authorised 19 January 2015

  • Application: EMEA/H/C/003724
  • Marketing authorisation holder: Sanofi B.V.
  • Local brand name: Cerdelga
  • 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. 
  • Pathway: orphan
  • Status: approved

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Eliglustat GZ385660 in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Eliglustat GZ385660 approved in European Union?

Yes. EMA authorised it on 19 January 2015.

Who is the marketing authorisation holder for Eliglustat GZ385660 in European Union?

Sanofi B.V. holds the EU marketing authorisation.