Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Kanuma   
Auth. number : EU/1/15/1033
Active substance : sebelipase alfa
Orphan market exclusivity for "Treatment of lysosomal acid lipase deficiency" (based on designation EU/3/10/827) started on 01/09/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 01/09/2025
ATC: Pending
Indication: Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) Deficiency.
Marketing Authorisation Holder: Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France
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
01/09/2015 Centralised - Authorisation EMEA/H/C/4004 (2015)6112 of 28/08/2015
07/10/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4004/T/1 (2015)6873 of 05/10/2015