Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Galafold   
Auth. number : EU/1/15/1082
Active substance : migalastat
Orphan market exclusivity for "Treatment of Fabry disease" (based on designation EU/3/06/368) started on 31/05/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 31/05/2026
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: A16AX14 - migalastat
(See WHO ATC Index)
Indication: Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation (see the tables in section 5.1).
Marketing Authorisation Holder: Amicus Therapeutics Europe Limited
Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland
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
31/05/2016 Centralised - Authorisation EMEA/H/C/4059 (2016)3318 of 26/05/2016
19/09/2016 Centralised - Variation EMEA/H/C/4059/IB/3
Updated with Decision(2018)2318 of 12/04/2018
13/10/2016 Centralised - Variation EMEA/H/C/4059/II/1
Updated with Decision(2018)2318 of 12/04/2018
13/10/2016 Centralised - Variation EMEA/H/C/4059/II/2
Updated with Decision(2018)2318 of 12/04/2018
11/05/2017 Centralised - Variation EMEA/H/C/4059/II/9
Updated with Decision(2018)2318 of 12/04/2018
26/10/2017 Centralised - Variation EMEA/H/C/4059/II/10
Updated with Decision(2018)2318 of 12/04/2018
26/10/2017 Centralised - Variation EMEA/H/C/4059/II/11
Updated with Decision(2018)2318 of 12/04/2018
16/01/2018 Centralised - Variation EMEA/H/C/4059/IB/13
Updated with Decision(2018)2318 of 12/04/2018
16/04/2018 Centralised - Yearly update (2018)2318 of 12/04/2018
30/04/2018 Centralised - Variation EMEA/H/C/4059/IB/15
Updated with Decision(2019)2580 of 28/03/2019
2/10/2018 Centralised - Variation EMEA/H/C/4059/IB/17
Updated with Decision(2019)2580 of 28/03/2019
25/02/2019 Centralised - Variation EMEA/H/C/004059/IAIN/0018
Updated with Decision(2019)2580 of 28/03/2019
1/04/2019 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/004059/T/0020 (2019)2580 of 28/03/2019