Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: IDELVION   
Auth. number : EU/1/16/1095
Active substance : albutrepenonacog alfa
Orphan market exclusivity for "Treatment of haemophilia B" (based on designation EU/3/09/723) started on 13/05/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 13/05/2026
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B02 - Antihemorrhagics
Pharmacological subgroup: B02B - Vitamin K and other hemostatics
Chemical subgroup: B02BD - Blood coagulation factors
Chemical substance: B02BD04 - Coagulation factor IX
(See WHO ATC Index)
Indication: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

IDELVION can be used for all age groups.
Marketing Authorisation Holder: CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland
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
13/05/2016 Centralised - Authorisation EMEA/H/C/3955 (2016)2943 of 11/05/2016
28/09/2016 Centralised - Notification EMEA/H/C/3955/N/0002
29/03/2017 Centralised - Variation EMEA/H/C/003955/IB/0006
21/04/2017 Centralised - Variation EMEA/H/C/003955/II/05