Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NovoEight   
Auth. number : EU/1/13/888
INN : 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, DK-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