Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: ReFacto AF   
Auth. number : EU/1/99/103
INN : Moroctocog 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).ReFacto AF is appropriate for use in adults and children of all ages, including newborns.ReFacto AF does not contain von Willebrand factor, and hence is not indicated in von Willebrand´s disease.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  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 continues to be 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
15/04/1999 Centralised - Authorisation EMEA/H/C/232 (1999)938 of 13/04/1999
02/02/2000 Centralised - Variation EMEA/H/C/232/N/2 (2000)125 of 31/01/2000
10/04/2000 Centralised - Variation EMEA/H/C/232/N/5 (2000)948 of 06/04/2000
24/08/2000 Centralised - Variation EMEA/H/C/232/I/6 (2000)2384 of 11/08/2000
29/12/2000 Centralised - Variation EMEA/H/C/232/I/7 (2000)3988 of 27/12/2000
28/02/2001 Centralised - Variation EMEA/H/C/232/I/8 (2001)281 of 23/02/2001
03/09/2001 Centralised - Variation EMEA/H/C/232/II/9
31/10/2001 Centralised - Variation EMEA/H/C/232/II/10
05/11/2001 Centralised - Variation EMEA/H/C/232/I/16
23/01/2002 Centralised - Variation EMEA/H/C/232/II/13
23/01/2002 Centralised - Variation EMEA/H/C/232/II/13
01/03/2002 Centralised - Variation EMEA/H/C/232/I/4
05/03/2002 Centralised - Variation EMEA/H/C/232/I/20 (2002)939 of 28/02/2002
29/04/2002 Centralised - Variation EMEA/H/C/232/II/21
27/06/2002 Centralised - Variation EMEA/H/C/232/II/14 (2002)2474 of 25/06/2002
22/08/2002 Centralised - Variation EMEA/H/C/232/II/15 (2002)3163 of 20/08/2002
23/09/2002 Centralised - Variation EMEA/H/C/232/N/25 (2002)3547 of 18/09/2002
21/10/2002 Centralised - Variation EMEA/H/C/232/II/24
10/12/2002 Centralised - Variation EMEA/H/C/232/II/23
07/01/2003 Centralised - Variation EMEA/H/C/232/X/22 (2002)5505 of 19/12/2002
26/03/2003 Centralised - Variation EMEA/H/C/232/II/27
13/05/2003 Centralised - Variation EMEA/H/C/232/II/26 (2003)1574 of 08/05/2003
19/05/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/232/T/28 (2003)1681 of 15/05/2003
22/07/2003 Centralised - Variation EMEA/H/C/232/I/29
23/09/2003 Centralised - Variation EMEA/H/C/232/I/35
02/10/2003 Centralised - Variation EMEA/H/C/232/I/30
23/10/2003 Centralised - Variation EMEA/H/C/232/II/34
05/12/2003 Centralised - Variation EMEA/H/C/232/I/33
15/12/2003 Centralised - Variation EMEA/H/C/232/II/32
15/12/2003 Centralised - Variation EMEA/H/C/232/I/36
Updated with Decision(2004)2900 of 20/07/2004
15/03/2004 Centralised - Variation EMEA/H/C/232/I/40
19/03/2004 Centralised - Variation EMEA/H/C/232/IA/41
31/03/2004 Centralised - Variation EMEA/H/C/232/II/39
23/07/2004 Centralised - Renewal EMEA/H/C/232/R/38 (2004)2900 of 20/07/2004
02/08/2004 Centralised - Variation EMEA/H/C/232/II/37 (2004)3005 of 29/07/2004
29/11/2004 Centralised - Variation EMEA/H/C/232/II/42 (2004)4628 of 25/11/2004
18/02/2005 Centralised - Variation EMEA/H/C/232/IA/43
Updated with Decision(2005)2965 of 27/07/2005
29/07/2005 Centralised - Variation EMEA/H/C/232/II/44 (2005)2965 of 27/07/2005
10/11/2005 Centralised - Variation EMEA/H/C/232/IB/45
31/01/2006 Centralised - Variation EMEA/H/C/232/II/48
31/01/2006 Centralised - Variation EMEA/H/C/232/II/46
31/01/2006 Centralised - Variation EMEA/H/C/232/II/47
07/06/2006 Centralised - Variation EMEA/H/C/232/II/49
26/06/2006 Centralised - Variation EMEA/H/C/232/IB/52
03/07/2006 Centralised - Variation EMEA/H/C/232/IA/54
03/07/2006 Centralised - Variation EMEA/H/C/232/IA/53
03/07/2006 Centralised - Variation EMEA/H/C/232/II/50
07/07/2006 Centralised - Variation EMEA/H/C/232/IA/55
Updated with Decision(2007)498 of 09/02/2007
20/10/2006 Centralised - Variation EMEA/H/C/232/II/51
13/02/2007 Centralised - Variation (2007)498 of 09/02/2007
27/07/2007 Centralised - Variation EMEA/H/C/232/II/57 (2007)3684 of 24/07/2007
24/10/2007 Centralised - Variation EMEA/H/C/232/II/69
13/11/2008 Centralised - Variation EMEA/H/C/232/IB/71
19/12/2008 Centralised - Variation EMEA/H/C/232/IB/70
Updated with Decision(2009)1453 of 26/02/2009
12/01/2009 Centralised - Variation EMEA/H/C/232/II/65
12/01/2009 Centralised - Variation EMEA/H/C/232/II/59
12/01/2009 Centralised - Variation EMEA/H/C/232/II/62
12/01/2009 Centralised - Variation EMEA/H/C/232/II/60
12/01/2009 Centralised - Variation EMEA/H/C/232/II/67
12/01/2009 Centralised - Variation EMEA/H/C/232/II/63
12/01/2009 Centralised - Variation EMEA/H/C/232/II/61
12/01/2009 Centralised - Variation EMEA/H/C/232/II/64
27/02/2009 Centralised - Variation EMEA/H/C/232/II/66, 68 (2009)1452 of 26/02/2009
02/03/2009 Centralised - Variation EMEA/H/C/232/II/66, 68 (2009)1453 of 26/02/2009
20/04/2009 Centralised - Renewal EMEA/H/C/232/R/72 (2009)3025 of 16/04/2009
27/04/2009 Centralised - Variation EMEA/H/C/232/II/73
02/07/2009 Centralised - Variation EMEA/H/C/232/II/74 (2009)5399 of 01/07/2009
13/07/2009 Centralised - Variation EMEA/H/C/232/IA/75
Updated with Decision(2010)894 of 08/02/2010
13/07/2009 Centralised - Variation EMEA/H/C/232/IA/76
Updated with Decision(2010)894 of 08/02/2010
10/02/2010 Centralised - Variation (2010)894 of 08/02/2010
09/03/2010 Centralised - Variation EMEA/H/C/232/N/77
Updated with Decision(2010)4835 of 07/07/2010
21/04/2010 Centralised - Variation EMEA/H/C/232/IA/80
Updated with Decision(2010)4835 of 07/07/2010
21/04/2010 Centralised - Variation EMEA/H/C/232/IA/79
Updated with Decision(2010)4835 of 07/07/2010
21/04/2010 Centralised - Variation EMEA/H/C/232/IA/81
Updated with Decision(2010)4835 of 07/07/2010
21/04/2010 Centralised - Variation EMEA/H/C/232/IA/82
Updated with Decision(2010)4835 of 07/07/2010
21/04/2010 Centralised - Variation EMEA/H/C/232/IA/78
Updated with Decision(2010)4835 of 07/07/2010
06/05/2010 Centralised - Variation EMEA/H/C/232/IA/85
28/05/2010 Centralised - Variation EMEA/H/C/232/IB/83
Updated with Decision(2010)4835 of 07/07/2010
28/05/2010 Centralised - Variation EMEA/H/C/232/IA/86
28/05/2010 Centralised - Variation EMEA/H/C/232/IB/86
29/06/2010 Centralised - Variation EMEA/H/C/232/IA/88
12/07/2010 Centralised - Variation (2010)4835 of 07/07/2010
02/08/2010 Centralised - Variation EMEA/H/C/232/IB/89
03/11/2010 Centralised - Variation EMEA/H/C/232/N/91
Updated with Decision(2011)3232 of 06/05/2011
14/12/2010 Centralised - Variation EMEA/H/C/232/N/92
Updated with Decision(2011)3232 of 06/05/2011
19/04/2011 Centralised - Variation EMEA/H/C/232/WS/117
10/05/2011 Centralised - Variation EMEA/H/C/232/X/87, 90 (2011)3233 of 06/05/2011
12/05/2011 Centralised - Variation EMEA/H/C/232/X/87, 90 (2011)3232 of 06/05/2011
20/07/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/232/T/93 (2011)5296 of 18/07/2011
08/09/2011 Centralised - Variation EMEA/H/C/232/IA/97
Updated with Decision(2011)8857 of 24/11/2011
29/11/2011 Centralised - Variation (2011)8857 of 24/11/2011
26/06/2012 Centralised - Variation EMEA/H/C/232/IB/106
Updated with Decision(2012)6129 of 30/08/2012
03/09/2012 Centralised - Variation EMEA/H/C/232/II/102 (2012)6129 of 30/08/2012
26/10/2012 Centralised - Variation EMEA/H/C/232/II/109 (2012)7644 of 24/10/2012
07/08/2013 Centralised - Variation EMEA/H/C/232/N/116
Updated with Decision(2013)8062 of 13/11/2013
15/11/2013 Centralised - Renewal EMEA/H/C/232/R/115 (2013)8062 of 13/11/2013