Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: ALPROLIX   
Auth. number : EU/1/16/1098
Active substance : eftrenonacog alfa
Orphan market exclusivity for "Treatment of haemophilia B (congenital factor IX deficiency)" (based on designation EU/3/07/453) 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).

ALPROLIX can be used for all age groups.
Marketing Authorisation Holder: Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sverige
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/4142 (2016)2990 of 12/05/2016
23/06/2016 Corrigendum (2016)2990 of 12/05/2016
04/10/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4142/T/0001 (2016)6431 of 30/09/2016
26/10/2016 Centralised - Notification EMEA/H/C/004142/N/0004
Updated with Decision(2017)4485 of 23/06/2017
13/06/2017 Centralised - Variation EMEA/H/C/004142/IB/0007
28/06/2017 PSUSA - Modification EMEA/H/C/PSUSA/00010499/201609 (2017)4485 of 23/06/2017