Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cerdelga   
Auth. number : EU/1/14/974
Active substance : eliglustat
Orphan market exclusivity for "Treatment of Gaucher Disease" (based on designation EU/3/07/514) started on 21/01/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 21/01/2025
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AX - Various alimentary tract and metabolism products
Chemical substance: A16AX10 - eliglustat
(See WHO ATC Index)
Indication: Cerdelga 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).
Marketing Authorisation Holder: Genzyme Europe B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/01/2015 Centralised - Authorisation EMEA/H/C/3724 (2015)291 of 19/01/2015
11/03/2015 Centralised - Variation EMEA/H/C/3724/IB/1
Updated with Decision(2016)1333 of 25/02/2016
1/03/2016 Centralised - Yearly update (2016)1333 of 25/02/2016
23/02/2017 Centralised - Variation EMEA/H/C/3724/II/8
Updated with Decision(2018)580 of 26/01/2018
23/03/2017 Centralised - Variation EMEA/H/C/3724/II/10
Updated with Decision(2018)580 of 26/01/2018
11/05/2017 Centralised - Variation EMEA/H/C/3724/II/11
Updated with Decision(2018)580 of 26/01/2018
1/09/2017 Centralised - Variation EMEA/H/C/3724/II/13
Updated with Decision(2018)580 of 26/01/2018
30/01/2018 Centralised - Yearly update (2018)580 of 26/01/2018
11/06/2018 Centralised - 2-Monthly update EMEA/H/C/3724/II/15/G (2018)3754 of 7/06/2018
20/12/2018 Centralised - Variation EMEA/H/C/IG/1003