Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: TachoSil   
Auth. number : EU/1/04/277
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: Supportive treatment in surgery for improvement of haemostasis,to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient.
Marketing Authorisation Holder: Takeda Austria GmbH
St.-Peter-Strasse 25, A-4020 Linz, 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
11/06/2004 Centralised - Authorisation EMEA/H/C/505 (2004)2080 of 08/06/2004
29/10/2004 Centralised - Variation EMEA/H/C/505/IA/2
Updated with Decision(2005)1805 of 10/06/2005
29/10/2004 Centralised - Variation EMEA/H/C/505/IA/1
Updated with Decision(2005)1805 of 10/06/2005
18/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/IA/3
09/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/IA/4
14/06/2005 Centralised - Variation (2005)1805 of 10/06/2005
20/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/II/7
02/03/2006 Centralised - Variation EMEA/H/C/505/II/6 (2006)688 of 28/02/2006
03/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/II/9
08/11/2006 Centralised - Variation EMEA/H/C/505/IA/11
Updated with Decision(2007)3841 of 03/08/2007
02/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/II/12
26/07/2007 Centralised - Variation EMEA/H/C/505/IA/15
Updated with Decision(2008)1339 of 04/04/2008
30/07/2007 Centralised - Notification EMEA/H/C/505/N/16
Updated with Decision(2008)1339 of 04/04/2008
07/08/2007 Centralised - Variation (2007)3841 of 03/08/2007
28/11/2007 Centralised - Notification EMEA/H/C/505/N/17
Updated with Decision(2008)1339 of 04/04/2008
25/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/II/18
09/04/2008 Centralised - Variation (2008)1339 of 04/04/2008
19/05/2008 Centralised - Notification EMEA/H/C/505/N/20
Updated with Decision(2009)1022 of 10/02/2009
12/02/2009 Centralised - Variation EMEA/H/C/505/II/19 (2009)1022 of 10/02/2009
05/05/2009 Centralised - Renewal EMEA/H/C/505/R/23 (2009)3576 of 30/04/2009
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/IA/28
28/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/II/25, 27
05/07/2010 Centralised - Variation EMEA/H/C/505/II/26 (2010)4670 of 01/07/2010
23/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/IB/29/G
16/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/505/IA/30
06/12/2010 Centralised - Notification EMEA/H/C/505/N/31
Updated with Decision(2012)9862 of 18/12/2012
26/08/2011 Centralised - Notification EMEA/H/C/505/N/33
Updated with Decision(2012)9862 of 18/12/2012
20/12/2012 Centralised - 2-Monthly update EMEA/H/C/505/II/41 (2012)9862 of 18/12/2012
22/04/2013 Centralised - Variation EMEA/H/C/505/IAin/48/G
Updated with Decision(2014)2065 of 21/03/2014
06/12/2013 Centralised - Notification EMEA/H/C/505/N/49
Updated with Decision(2014)2065 of 21/03/2014
25/03/2014 Centralised - Yearly update (2014)2065 of 21/03/2014
25/09/2014 Centralised - Variation EMEA/H/C/505/II/52