Pharmaceuticals - Union Register

  

Union 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 1/09/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/09/2025
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: A16AB - Enzymes
Chemical substance: A16AB14 - sebelipase alfa
(See WHO ATC Index)
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/09/2015 Centralised - Authorisation EMEA/H/C/4004 (2015)6112 of 28/08/2015
7/10/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4004/T/1 (2015)6873 of 5/10/2015
12/10/2017 Centralised - Variation EMEA/H/C/4004/IAIN/12
Updated with Decision(2018)6245 of 20/09/2018
24/09/2018 Centralised - Yearly update (2018)6245 of 20/09/2018
17/12/2018 Centralised - Variation EMEA/H/C/4004/IB/17