Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Nuwiq   
Auth. number : EU/1/14/936
Active substance : simoctocog 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).
Nuwiq can be used for all age groups.
Marketing Authorisation Holder: Octapharma AB
Lars Forssells gata 23, 112 75 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
24/07/2014 Centralised - Authorisation EMEA/H/C/2813 (2014)5318 of 22/07/2014
2/10/2014 Corrigendum (2014)7154 of 30/09/2014
14/01/2015 Corrigendum (2015)120 of 12/01/2015
25/09/2015 Centralised - Variation EMEA/H/C/2813/IAIN/5/G
Updated with Decision(2016)6296 of 26/09/2016
11/11/2015 Centralised - Variation EMEA/H/C/2813/IB/6
Updated with Decision(2016)6296 of 26/09/2016
28/10/2016 Centralised - Yearly update (2016)6296 of 26/09/2016
14/09/2017 Centralised - Variation EMEA/H/C/2813/II/17/G
Updated with Decision(2017)7982 of 24/11/2017
28/11/2017 Referral EMEA/H/C/2813/A31/15 (2017)7982 of 24/11/2017
27/03/2018 Centralised - Variation EMEA/H/C/2813/X/20 (2018)1963 of 23/03/2018