Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Advate   
Auth. number : EU/1/03/271
INN : 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). ADVATE is indicated in all age groups.
Marketing Authorisation Holder: Baxter AG
Industriestraße 67, A-1221 Wien, Österreich

  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
04/03/2004 Centralised - Authorisation EMEA/H/C/520 (2004)718 of 02/03/2004
04/08/2004 Centralised - Variation EMEA/H/C/520/II/1
22/09/2004 Centralised - Variation EMEA/H/C/520/II/3
23/12/2004 Centralised - Variation EMEA/H/C/520/II/4 (2004)5558 of 21/12/2004
23/03/2005 Centralised - Variation EMEA/H/C/520/IA/7
04/05/2005 Centralised - Variation EMEA/H/C/520/IB/6
01/06/2005 Centralised - Variation EMEA/H/C/520/II/8
15/08/2005 Centralised - Variation EMEA/H/C/520/IA/10
Updated with Decision(2005)4504 of 15/11/2005
01/09/2005 Centralised - Variation EMEA/H/C/520/IB/11
18/11/2005 Centralised - Variation EMEA/H/C/520/II/9 (2005)4504 of 15/11/2005
22/11/2005 Centralised - Variation EMEA/H/C/520/II/14
19/12/2005 Centralised - Variation EMEA/H/C/520/II/13
02/02/2006 Centralised - Variation EMEA/H/C/520/II/12
27/03/2006 Centralised - Variation EMEA/H/C/520/II/15
03/08/2006 Centralised - Variation EMEA/H/C/520/N/17
Updated with Decision(2007)188 of 17/01/2007
11/09/2006 Centralised - Variation EMEA/H/C/520/II/16
19/01/2007 Centralised - Variation EMEA/H/C/520/II/18, 19 (2007)188 of 17/01/2007
20/03/2007 Centralised - Variation EMEA/H/C/520/IB/21
28/03/2007 Centralised - Variation EMEA/H/C/520/II/20
27/07/2007 Centralised - Variation EMEA/H/C/520/II/22 (2007)3685 of 24/07/2007
22/11/2007 Centralised - Variation EMEA/H/C/520/II/24
21/12/2007 Centralised - Variation EMEA/H/C/520/II/25
28/02/2008 Centralised - Variation EMEA/H/C/520/II/26
28/05/2008 Centralised - Variation EMEA/H/C/520/X/23 (2008)2239 of 22/05/2008
30/05/2008 Centralised - Variation EMEA/H/C/520/IB/27
25/09/2008 Centralised - Variation EMEA/H/C/520/IA/29
26/01/2009 Centralised - Variation EMEA/H/C/520/II/31
27/02/2009 Centralised - Variation EMEA/H/C/520/II/30
02/03/2009 Centralised - Renewal EMEA/H/C/520/R/28 (2009)1451 of 26/02/2009
01/04/2009 Centralised - Variation EMEA/H/C/520/IB/34
06/04/2009 Centralised - Variation EMEA/H/C/520/IB/35
03/06/2009 Centralised - Variation EMEA/H/C/520/II/33 (2009)4356 of 29/05/2009
26/11/2009 Centralised - Variation EMEA/H/C/520/II/36
29/04/2010 Centralised - Variation EMEA/H/C/520/II/37
14/09/2010 Centralised - Variation EMEA/H/C/520/IB/40
05/10/2010 Centralised - Variation EMEA/H/C/520/IB/39
08/03/2011 Centralised - Variation EMEA/H/C/520/IA/42
04/07/2011 Centralised - Variation EMEA/H/C/520/II/38 (2011)4812 of 29/06/2011
21/12/2011 Centralised - Variation EMEA/H/C/520/X/41 (2011)9937 of 19/12/2011
16/02/2012 Centralised - Variation EMEA/H/C/520/IB/44
Updated with Decision(2012)6399 of 10/09/2012
12/09/2012 Centralised - Variation (2012)6399 of 10/09/2012
30/05/2013 Centralised - Variation EMEA/H/C/520/II/50
Updated with Decision(2013)9847 of 20/12/2013
19/09/2013 Centralised - Variation EMEA/H/C/520/II/49
Updated with Decision(2013)9847 of 20/12/2013
06/01/2014 Centralised - Renewal EMEA/H/C/520/R/52 (2013)9847 of 20/12/2013
23/01/2014 Centralised - Variation EMEA/H/C/520/II/53/G