Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: NovoEight   
Auth. number : EU/1/13/888
Active substance : turoctocog alfa
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: B02BD02 - coagulation factor VIII
(See WHO ATC Index)
Indication: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
NovoEight can be used for all age groups.
Marketing Authorisation Holder: Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd, Danmark
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
15/11/2013 Centralised - Authorisation EMEA/H/C/2719 (2013)8066 of 13/11/2013
11/03/2015 Centralised - Variation EMEA/H/C/2719/IB/5/G
Updated with Decision(2016)3001 of 12/05/2016
24/03/2015 Centralised - Variation EMEA/H/C/2719/IB/4
Updated with Decision(2016)3001 of 12/05/2016
3/06/2015 Centralised - Variation EMEA/H/C/2719/IA/7
Updated with Decision(2016)3001 of 12/05/2016
18/06/2015 Centralised - Notification EMEA/H/C/2719/N/6
Updated with Decision(2016)3001 of 12/05/2016
17/05/2016 Centralised - Yearly update (2016)3001 of 12/05/2016
28/04/2017 Centralised - Variation EMEA/H/C/2719/IB/19
Updated with Decision(2017)7770 of 15/11/2017
17/11/2017 Referral EMEA/H/C/2719/A31/14 (2017)7770 of 15/11/2017
19/04/2018 Centralised - Variation EMEA/H/C/2719/II/21/G
Updated with Decision(2018)5093 of 26/07/2018
30/07/2018 Centralised - 2-Monthly update EMEA/H/C/2719/II/23 (2018)5093 of 26/07/2018
1/08/2018 Centralised - Renewal EMEA/H/C/2719/R/25 (2018)5226 of 30/07/2018