Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ceprotin   
Auth. number : EU/1/01/190
Active substance : Protein C
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AD - Enzymes
Chemical substance: B01AD12 - Protein C
(See WHO ATC Index)
Indication: Ceprotin is indicated in purpura fulminans and coumarin-induced skin necrosis in patients with severe congenital protein C deficiency. Furthermore Ceprotin is indicated for short-term prophylaxis in patients with severe congenital protein C deficiency if one or more of the following conditions are met:- surgery or invasive therapy is imminent- while initiating coumarin therapy- when coumarin therapy alone is not sufficient- when coumarin therapy is not feasible.
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
17/07/2001 Centralised - Authorisation EMEA/H/C/334 (2001)2015 of 16/07/2001
08/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/3
08/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/1
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/2
21/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/5
28/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/4
19/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/9
22/04/2002 Centralised - Notification EMEA/H/C/334/N/8 (2002)1557 of 18/04/2002
06/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/7
07/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/6
12/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/11
09/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/10
24/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/13
22/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/12
08/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/17
08/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/18
09/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/14
03/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/15
17/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/21
16/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/24
02/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/22
02/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/20
03/07/2003 Centralised - Annual reassessment EMEA/H/C/334/S/16 (2003)2242 of 30/06/2003
17/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/25
28/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/19
02/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/23
22/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/28
19/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/I/30
26/02/2004 Centralised - Annual reassessment EMEA/H/C/334/S/27 (2004)632 of 23/02/2004
30/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/31
29/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/33
29/09/2004 Centralised - Variation EMEA/H/C/334/II/34 (2004)3654 of 27/09/2004
03/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/IB/36
09/03/2005 Centralised - Annual reassessment EMEA/H/C/334/S/35 (2005)659 of 07/03/2005
23/01/2006 Centralised - Annual reassessment EMEA/H/C/334/S/37 (2006)131 of 19/01/2006
29/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/41
29/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/40
02/08/2006 Centralised - Renewal EMEA/H/C/334/R/42 (2006)3542 of 28/07/2006
19/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/45
09/01/2007 Centralised - Variation EMEA/H/C/334/II/44 (2007)15 of 03/01/2007
01/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/47
14/08/2007 Centralised - Variation EMEA/H/C/334/II/46 (2007)3921 of 10/08/2007
30/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/49
02/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/IB/51
28/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/IB/52
06/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/IB/53
01/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/54
20/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/IA/56
29/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/IB/57
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/IB/58
16/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/IA/59/G
25/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/334/II/60
04/11/2011 Centralised - Variation EMEA/H/C/334/II/64 (2011)7939 of 27/10/2011
13/03/2015 Centralised - Notification EMEA/H/C/334/N/82
05/05/2015 Centralised - Variation EMEA/H/C/334/IB/83