Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Brineura   
Auth. number : EU/1/17/1192
Active substance : cerliponase alfa
Orphan market exclusivity for "Treatment of neuronal ceroid lipofuscinosis type 2" (based on designation EU/3/13/1118) started on 01/06/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 01/06/2027
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: A16AB - Enzymes
(See WHO ATC Index)
Indication: Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Marketing Authorisation Holder: BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, 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 Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/06/2017 Centralised - Authorisation EMEA/H/C/4065 (2017)3850 of 30/05/2017