Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Revasc   
Auth. number : EU/1/97/043
INN : Desirudin
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AE - Direct thrombin inhibitors
Chemical substance: B01AE01 - Desirudin
(See WHO ATC Index)
Indication: Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery.
Marketing Authorisation Holder: Canyon Pharmaceuticals Ltd
7th Floor, 52-54 Gracechurch Street, London EC3V 0EH, 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 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
10/07/1997 Centralised - Authorisation EMEA/H/C/104 (97)2130 of 09/07/1997
06/08/1998 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/104/T/2 (1998)2471 of 05/08/1998
22/09/1998 Centralised - Variation EMEA/H/C/104/I/1 (1998)2518 of 18/09/1998
29/01/1999 Centralised - Variation EMEA/H/C/104/N/3 (1999)173 of 26/01/1999
16/03/1999 Centralised - Variation EMEA/H/C/104/I/4 (1999)579 of 12/03/1999
29/03/2000 Centralised - Variation EMEA/H/C/104/I/6, 7
02/08/2000 Centralised - Variation EMEA/H/C/104/II/8
07/08/2000 Centralised - Variation EMEA/H/C/104/I/9 (2000)2370 of 01/08/2000
24/01/2001 Centralised - Variation EMEA/H/C/104/II/10 (2001)78 of 22/01/2001
06/08/2002 Centralised - Renewal EMEA/H/C/104/R/11 (2002)3063 of 02/08/2002
01/07/2003 Centralised - Variation EMEA/H/C/104/I/15
01/07/2003 Centralised - Variation EMEA/H/C/104/I/14
29/01/2004 Centralised - Variation EMEA/H/C/104/II/12 (2004)220 of 27/01/2004
19/10/2004 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/104/T/16 (2004)4051 of 13/10/2004
03/01/2005 Centralised - Variation (2005)6014 of 23/12/2005
29/05/2005 Centralised - Variation EMEA/H/C/104/IA/17
30/06/2005 Centralised - Variation EMEA/H/C/104/IB/18
Updated with Decision(2005)6014 of 23/12/2005
23/12/2005 Centralised - Variation EMEA/H/C/104/IB/19
Updated with Decision(2006)3305 of 14/07/2006
03/02/2006 Centralised - Variation EMEA/H/C/104/II/20
20/07/2006 Centralised - Variation (2006)3305 of 14/07/2006
23/11/2006 Centralised - Variation EMEA/H/C/104/IA/23
23/11/2006 Centralised - Variation EMEA/H/C/104/I/22
30/11/2006 Centralised - Variation EMEA/H/C/104/IA/24
Updated with Decision(2007)3139 of 21/06/2007
25/06/2007 Centralised - Renewal EMEA/H/C/104/R/25 (2007)3139 of 21/06/2007
20/09/2007 Centralised - Variation EMEA/H/C/104/IA/26
Updated with Decision(2008)1523 of 14/04/2008
16/04/2008 Centralised - Variation (2008)1523 of 14/04/2008
25/03/2009 Centralised - Variation EMEA/H/C/104/IB/27
30/03/2009 Centralised - Variation EMEA/H/C/104/IB/27
11/01/2010 Centralised - Variation EMEA/H/C/104/II/28 (2009)10704 of 21/12/2009
27/04/2011 Centralised - Variation EMEA/H/C/104/II/30 (2011)2941 of 20/04/2011
23/01/2012 Centralised - Variation EMEA/H/C/104/IA/31/G
Updated with Decision(2012)6849 of 24/09/2012
26/09/2012 Centralised - Variation (2012)6849 of 24/09/2012