Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Vimizim   
Auth. number : EU/1/14/914
Active substance : elosulfase alfa
Orphan market exclusivity for "Treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome)" (based on designation EU/3/09/657) started on 30/04/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 30/04/2024
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: A16AB - Enzymes
Chemical substance: A16AB12 - Elosulfase alfa
(See WHO ATC Index)
Indication: Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
Marketing Authorisation Holder: BioMarin Europe Ltd.
10 Bloomsbury Way, London WC1A 2SL, United Kingdom
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 Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/04/2014 Centralised - Authorisation EMEA/H/C/2779 (2014)2921 of 28/04/2014
09/07/2014 Centralised - Variation EMEA/H/C/2779/IG/458
Updated with Decision(2015)4864 of 08/07/2015
23/10/2014 Centralised - Variation EMEA/H/C/2779/II/4
Updated with Decision(2015)4864 of 08/07/2015
26/03/2015 Centralised - Variation EMEA/H/C/2779/II/6
Updated with Decision(2015)4864 of 08/07/2015
10/07/2015 Centralised - Yearly update (2015)4864 of 08/07/2015
02/02/2016 Centralised - Variation EMEA/H/C/2779/IG/658
Updated with Decision(2017)177 of 11/01/2017
13/01/2017 Centralised - Yearly update (2017)177 of 11/01/2017