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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Ceprotin
|
| Auth. number : | EU/1/01/190 |
| INN : | Protein C |
| ATC: | B - Blood and blood forming organs B01 - Antithrombotic agents B01A - Antithrombotic agents B01AD - Enzymes 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 procedures
| 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 | EMEA/H/C/334/II/3 | ||||
| 08/10/2001 | Centralised - Variation | EMEA/H/C/334/I/1 | ||||
| 28/11/2001 | Centralised - Variation | EMEA/H/C/334/II/2 | ||||
| 21/01/2002 | Centralised - Variation | EMEA/H/C/334/I/5 | ||||
| 28/01/2002 | Centralised - Variation | EMEA/H/C/334/I/4 | ||||
| 19/03/2002 | Centralised - Variation | EMEA/H/C/334/I/9 | ||||
| 22/04/2002 | Centralised - Variation | EMEA/H/C/334/N/8 | (2002)1557 of 18/04/2002 | |||
| 06/05/2002 | Centralised - Variation | EMEA/H/C/334/I/7 | ||||
| 07/06/2002 | Centralised - Variation | EMEA/H/C/334/I/6 | ||||
| 12/07/2002 | Centralised - Variation | EMEA/H/C/334/I/11 | ||||
| 09/09/2002 | Centralised - Variation | EMEA/H/C/334/II/10 | ||||
| 24/09/2002 | Centralised - Variation | EMEA/H/C/334/I/13 | ||||
| 22/10/2002 | Centralised - Variation | EMEA/H/C/334/II/12 | ||||
| 08/01/2003 | Centralised - Variation | EMEA/H/C/334/I/17 | ||||
| 08/01/2003 | Centralised - Variation | EMEA/H/C/334/I/18 | ||||
| 09/01/2003 | Centralised - Variation | EMEA/H/C/334/II/14 | ||||
| 03/03/2003 | Centralised - Variation | EMEA/H/C/334/II/15 | ||||
| 17/03/2003 | Centralised - Variation | EMEA/H/C/334/I/21 | ||||
| 16/05/2003 | Centralised - Variation | EMEA/H/C/334/I/24 | ||||
| 02/06/2003 | Centralised - Variation | EMEA/H/C/334/II/20 | ||||
| 02/06/2003 | Centralised - Variation | EMEA/H/C/334/I/22 | ||||
| 03/07/2003 | Centralised - Annual reassessment | EMEA/H/C/334/S/16 | (2003)2242 of 30/06/2003 | |||
| 17/07/2003 | Centralised - Variation | EMEA/H/C/334/I/25 | ||||
| 28/07/2003 | Centralised - Variation | EMEA/H/C/334/I/19 | ||||
| 02/10/2003 | Centralised - Variation | EMEA/H/C/334/II/23 | ||||
| 22/10/2003 | Centralised - Variation | EMEA/H/C/334/I/28 | ||||
| 19/01/2004 | Centralised - Variation | 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 | EMEA/H/C/334/II/31 | ||||
| 29/07/2004 | Centralised - Variation | 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 | 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 | EMEA/H/C/334/II/40 | ||||
| 29/03/2006 | Centralised - Variation | EMEA/H/C/334/II/41 | ||||
| 02/08/2006 | Centralised - Renewal | EMEA/H/C/334/R/42 | (2006)3542 of 28/07/2006 | |||
| 19/12/2006 | Centralised - Variation | 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 | 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 | EMEA/H/C/334/II/49 | ||||
| 02/12/2008 | Centralised - Variation | EMEA/H/C/334/IB/51 | ||||
| 28/01/2009 | Centralised - Variation | EMEA/H/C/334/IB/52 | ||||
| 06/04/2009 | Centralised - Variation | EMEA/H/C/334/IB/53 | ||||
| 01/03/2010 | Centralised - Variation | EMEA/H/C/334/II/54 | ||||
| 20/05/2010 | Centralised - Variation | EMEA/H/C/334/IA/56 | ||||
| 29/07/2010 | Centralised - Variation | EMEA/H/C/334/IB/57 | ||||
| 30/09/2010 | Centralised - Variation | EMEA/H/C/334/IB/58 | ||||
| 16/12/2010 | Centralised - Variation | EMEA/H/C/334/IA/59/G | ||||
| 25/04/2011 | Centralised - Variation | EMEA/H/C/334/II/60 | ||||
| 04/11/2011 | Centralised - Variation | EMEA/H/C/334/II/64 | (2011)7939 of 27/10/2011 |