Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Helixate NexGen   
Auth. number : EU/1/00/144
INN : Recombinant coagulation factor VIII (octocog 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)
Marketing Authorisation Holder: Bayer Pharma AG
D-13342 Berlin, Deutschland
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
07/08/2000 Centralised - Authorisation EMEA/H/C/276 (2000)2374 of 04/08/2000
23/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/1
20/12/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/I/3
10/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/2
25/10/2001 Centralised - Variation EMEA/H/C/276/I/6 (2001)2970 of 24/10/2001
19/12/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/7
30/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/I/8
05/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/4
25/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/10
23/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/11
09/12/2002 Centralised - Variation EMEA/H/C/276/II/9 (2002)5000 of 05/12/2002
04/02/2003 Centralised - Variation EMEA/H/C/276/I/12 (2003)462 of 31/01/2003
24/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/I/15
28/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/13
16/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/14
28/06/2004 Centralised - Variation EMEA/H/C/276/II/16, 17 (2004)2417 of 24/06/2004
01/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/18
26/11/2004 Centralised - Notification EMEA/H/C/276/N/21
Updated with Decision(2005)3473 of 07/09/2005
22/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/20
22/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/19
22/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/22
03/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/25
03/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/23
30/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/24
05/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/27
10/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/29
01/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/30
09/09/2005 Centralised - Renewal EMEA/H/C/276/R/26 (2005)3473 of 07/09/2005
19/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/28
15/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/32
19/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/31
27/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/38
28/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/39
30/03/2006 Centralised - Variation EMEA/H/C/276/IB/37
Updated with Decision(2006)5213 of 26/10/2006
05/04/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/276/T/41 (2006)1515 of 03/04/2006
08/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/40
03/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/44
08/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/48
09/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/49
14/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/47
27/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/45
30/10/2006 Centralised - Variation EMEA/H/C/276/II/42 (2006)5213 of 26/10/2006
06/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/54
15/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/52
30/01/2007 Centralised - Variation EMEA/H/C/276/II/51 (2007)314 of 26/01/2007
02/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/55
13/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/64
13/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/63
18/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/65
24/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/57
27/07/2007 Centralised - Variation EMEA/H/C/276/II/58 (2007)3673 of 24/07/2007
27/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/272/II/66
27/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/62
02/11/2007 Centralised - Variation EMEA/H/C/276/II/61 (2007)5384 of 30/10/2007
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/68
20/12/2007 Centralised - Variation EMEA/H/C/276/X/56 (2007)6756 of 18/12/2007
29/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/70
26/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/69
28/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/71
11/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/74
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/75
09/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/78
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/73
28/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/76, 77
31/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/81
07/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/83
28/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/80
02/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/85
05/03/2009 Centralised - Variation EMEA/H/C/276/IA/88
Updated with Decision(2009)2868 of 07/04/2009
05/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/89
06/03/2009 Centralised - Variation EMEA/H/C/276/II/82 (2009)1654 of 04/03/2009
26/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/86
09/04/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/276/T/87 (2009)2868 of 07/04/2009
28/04/2009 Centralised - Variation EMEA/H/C/276/II/84 (2009)3283 of 24/04/2009
09/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/96
30/07/2009 Centralised - Variation EMEA/H/C/276/II/92 (2009)6113 of 27/07/2009
06/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/98
20/10/2009 Centralised - Variation EMEA/H/C/276/II/99 (2009)8133 of 16/10/2009
13/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/100
13/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/94
08/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/95
12/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/101
12/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/93
03/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/103
11/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/104
30/03/2010 Centralised - Variation EMEA/H/C/276/II/91 (2010)2185 of 26/03/2010
03/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/II/106
27/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/WS/14
27/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/WS/7
27/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/WS/8
21/06/2010 Centralised - Variation EMEA/H/C/276/IG/9
Updated with Decision(2010)5396 of 28/07/2010
22/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IG/12
30/07/2010 Centralised - Variation EMEA/H/C/276/WS/10 (2010)5396 of 28/07/2010
12/08/2010 Centralised - Renewal EMEA/H/C/276/R/105 (2010)5624 of 06/08/2010
16/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/WS/20
19/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IG/17
13/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IA/108
23/12/2010 Centralised - Variation EMEA/H/C/276/WS/62 (2010)9649 of 20/12/2010
10/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/WS/12
31/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/WS/83
04/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IB/109/G
04/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/IG/38
01/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/WS/94
15/11/2011 Centralised - Variation EMEA/H/C/276/IA/110/G
Updated with Decision(2011)8232 of 10/11/2011
15/11/2011 Centralised - Variation (2011)8232 of 10/11/2011
16/02/2012 Centralised - Variation EMEA/H/C/276/WS/155/G
22/03/2012 Centralised - Variation EMEA/H/C/275/WS/198 (2012)1933 of 19/03/2012
17/04/2012 Centralised - Variation EMEA/H/C/276/IB/132/G
Updated with Decision(2012)7624 of 23/10/2012
25/04/2012 Centralised - Variation EMEA/H/C/276/WS/193 (2012)2848 of 20/04/2012
20/09/2012 Centralised - Variation (no change in Commission Decision) EMEA/H/C/276/WS/274
26/10/2012 Centralised - Variation EMEA/H/C/276/WS/274, 289 (2012)7624 of 23/10/2012
19/09/2013 Centralised - Variation EMEA/H/C/276/WS/427/G
Updated with Decision(2014)1255 of 20/02/2014
24/02/2014 Referral EMEA/H/C/276/A-20/150 (2014)1255 of 20/02/2014
23/07/2014 Centralised - Notification EMEA/H/C/276/N/164