Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Nonafact   
Auth. number : EU/1/01/186
INN : Human coagulation factor IX
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)
Marketing Authorisation Holder: Sanquin
Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland

  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
04/07/2001 Centralised - Authorisation EMEA/H/C/348 (2001)1384 of 03/07/2001
14/05/2003 Centralised - Variation EMEA/H/C/348/I/2
14/05/2003 Centralised - Variation EMEA/H/C/348/I/1 (2003)1616 of 12/05/2003
05/08/2003 Centralised - Variation EMEA/H/C/348/I/3
26/01/2004 Centralised - Variation EMEA/H/C/348/II/5
13/04/2005 Centralised - Variation EMEA/H/C/348/IA/7
21/12/2005 Centralised - Variation EMEA/H/C/348/II/8
28/03/2006 Centralised - Variation EMEA/H/C/348/II/11
28/07/2006 Centralised - Renewal EMEA/H/C/348/R/12 (2006)3434 of 25/07/2006
08/05/2007 Centralised - Variation EMEA/H/C/348/IA/19
24/07/2007 Centralised - Variation EMEA/H/C/348/II/16
01/11/2007 Centralised - Variation EMEA/H/C/348/II/17 (2007)5380 of 30/10/2007
15/01/2008 Centralised - Variation EMEA/H/C/348/IB/20
02/10/2008 Centralised - Variation EMEA/H/C/348/II/22
19/02/2009 Centralised - Variation EMEA/H/C/348/IA/23
16/04/2009 Centralised - Variation EMEA/H/C/348/IB/24
21/06/2010 Centralised - Variation EMEA/H/C/348/IB/26
Updated with Decision(2011)574 of 27/01/2011
14/07/2010 Centralised - Variation EMEA/H/C/348/IA/27
01/02/2011 Centralised - Variation (2011)574 of 27/01/2011