Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NovoSeven   
Auth. number : EU/1/96/006
Active substance : Eptacog alfa (activated)
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: B02BD08 - Eptacog alfa (activated)
(See WHO ATC Index)
Indication: NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:
- in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda Units (BU)
- in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration
- in patients with acquired haemophilia- in patients with congenital FVII deficiency
- in patients with Glanzmann’s thrombasthenia with antibodies to GP IIb - IIIa and/or HLA, and with past or present refractoriness to platelet transfusions.
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
27/02/1996 Centralised - Authorisation EMEA/H/C/74 (96)427 of 23/02/1996
05/12/1997 Centralised - Variation EMEA/H/C/74/II/1 (97)3893 of 04/12/1997
29/06/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/6
20/07/1998 Centralised - Variation EMEA/H/C/74/I/8 (1998)2053 of 17/07/1998
26/11/1998 Centralised - Variation EMEA/H/C/74/II/7 (1998)3604 of 19/11/1998
03/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/12
08/03/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/13
16/12/1999 Centralised - Variation EMEA/H/C/74/II/14 (1999)4281 of 08/12/1999
12/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/16
28/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/15
06/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/19
07/05/2001 Centralised - Renewal EMEA/H/C/74/R/17 (2001)918 of 03/05/2001
22/06/2001 Centralised - Variation EMEA/H/C/74/II/18 (2001)1375 of 20/06/2001
29/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/20
29/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/21
15/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/22
09/12/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/23
10/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/25
10/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/24
22/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/I/32
10/10/2003 Centralised - Variation EMEA/H/C/74/II/27 (2003)3738 of 08/10/2003
29/01/2004 Centralised - Variation EMEA/H/C/74/II/30, 31 (2004)240 of 27/01/2004
29/01/2004 Centralised - Variation EMEA/H/C/74/II/28, 29 (2004)216 of 27/01/2004
03/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/35
26/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/34
27/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/40
03/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/38, 39
21/11/2005 Centralised - Variation EMEA/H/C/74/II/41 (2005)4516 of 16/11/2005
13/02/2006 Centralised - Renewal EMEA/H/C/74/R/43 (2006)445 of 09/02/2006
07/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/45
28/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/IB/49
08/08/2006 Centralised - Variation EMEA/H/C/74/II/47 (2006)3634 of 04/08/2006
23/08/2006 Centralised - Variation EMEA/H/C/74/II/46 (2006)3841 of 21/08/2006
23/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/51
21/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/48
09/01/2007 Centralised - Variation EMEA/H/C/74/II/52 (2007)22 of 04/01/2007
08/03/2007 Centralised - Variation EMEA/H/C/74/II/53 (2007)821 of 05/03/2007
06/09/2007 Centralised - Variation EMEA/H/C/74/II/54 (2007)4198 of 03/09/2007
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/56
28/04/2008 Centralised - Variation - Decision addressed to Member States EMEA/H/C/74/X/55 (2008)1731 of 25/04/2008
29/04/2008 Centralised - Variation EMEA/H/C/74/X/55 (2008)1730 of 25/04/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/58
15/08/2008 Centralised - Variation EMEA/H/C/74/IA/59
Updated with Decision(2009)2202 of 23/03/2009
27/08/2008 Centralised - Variation EMEA/H/C/74/II/57 (2008)4678 of 25/08/2008
28/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/61
25/03/2009 Centralised - Variation (2009)2202 of 23/03/2009
02/06/2009 Centralised - Variation EMEA/H/C/74/II/60 (2009)4323 of 28/05/2009
19/06/2009 Centralised - Variation EMEA/H/C/74/IA/62
Updated with Decision(2010)919 of 09/02/2010
11/02/2010 Centralised - Variation (2010)919 of 09/02/2010
04/11/2010 Centralised - Variation EMEA/H/C/74/II/64/G (2010)7627 of 28/10/2010
05/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/63
15/03/2011 Centralised - Variation EMEA/H/C/74/IG/48/G
Updated with Decision(2011)4627 of 23/06/2011
29/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/74/II/65/G
27/06/2011 Centralised - Variation (2011)4627 of 23/06/2011
17/01/2012 Centralised - Variation EMEA/H/C/74/II/69 (2012)188 of 13/01/2012
26/10/2012 Centralised - Variation EMEA/H/C/74/II/72/G (2012)7681 of 24/10/2012
25/04/2013 Centralised - Variation EMEA/H/C/74/II/74
Updated with Decision(2013)9743 of 18/12/2013
23/12/2013 Centralised - 2-Monthly update EMEA/H/C/74/II/73 (2013)9743 of 18/12/2013
18/05/2014 Centralised - Notification EMEA/H/C/74/N/79
21/01/2016 Centralised - Variation EMEA/H/C/74/II/90/G