Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Evicel   
Auth. number : EU/1/08/473
INN : human fibrinogen / human thrombin
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B02 - Antihemorrhagics
Pharmacological subgroup: B02B - Vitamin K and other hemostatics
Chemical subgroup: B02BC - Local hemostatics
Chemical substance: B02BC30 - Combinations
(See WHO ATC Index)
Indication: EVICEL is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.
EVICEL is also indicated as suture support for haemostasis in vascular surgery and for suture line sealing in dura mater closure.
Marketing Authorisation Holder: Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, B-1831 Diegem, België
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
09/10/2008 Centralised - Authorisation EMEA/H/C/898 (2008)5904 of 06/10/2008
02/03/2009 Corrigendum EMEA/H/C/898 (2009)1389 corr of 25/02/2009
28/04/2009 Centralised - Variation EMEA/H/C/898/II/1 (2009)3259 of 23/04/2009
30/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/898/II/2
15/12/2009 Centralised - Variation EMEA/H/C/898/II/5 (2009)10332 of 11/12/2009
15/02/2010 Centralised - Variation (rejected) EMEA/H/C/898/II/3 (2010)925 of 09/02/2010
01/04/2010 Centralised - Variation EMEA/H/C/898/II/4 (2010)2251 of 30/03/2010
11/08/2010 Centralised - Variation EMEA/H/C/898/II/6 (2010)5615 of 06/08/2010
03/01/2011 Centralised - Variation (refusal) EMEA/H/C/898/IA/8/G
17/01/2011 Centralised - Variation EMEA/H/C/898/IA/10/G
Updated with Decision(2011)2249 of 28/03/2011
02/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/898/II/7/G
08/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/898/II/9/G
05/04/2011 Centralised - Variation (2011)2249 of 28/03/2011
08/07/2011 Centralised - Variation EMEA/H/C/898/IB/12
Updated with Decision(2012)1375 of 27/02/2012
17/10/2011 Centralised - Variation EMEA/H/C/898/IA/13
Updated with Decision(2012)1375 of 27/02/2012
18/01/2012 Centralised - Variation EMEA/H/C/898/IB/14
Updated with Decision(2012)5478 of 26/07/2012
29/02/2012 Centralised - Variation (2012)1375 of 27/02/2012
30/07/2012 Centralised - Variation (2012)5478 of 26/07/2012
15/02/2013 Referral EMEA/H/C/898/A-20/18 (2013)933 of 13/02/2013
30/07/2013 Centralised - 2-Monthly update EMEA/H/C/898/II/21 (2013)5006 of 26/07/2013
22/11/2013 Centralised - Renewal EMEA/H/C/898/R/22 (2013)8342 of 20/11/2013
23/01/2014 Centralised - Variation EMEA/H/C/898/II/25/G
Updated with Decision(2015)460 of 27/01/2015
23/10/2014 Centralised - Variation EMEA/H/C/898/II/26
Updated with Decision(2015)460 of 27/01/2015
29/01/2015 Centralised - Yearly update (2015)460 of 27/01/2015