human fibrinogen / human thrombin
Table of contents
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
TachoSil : EPAR - Summary for the public (PDF/89.76 KB)
First published: 25/06/2009
Last updated: 25/05/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Corza Medical GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
Corza Medical GmbH
15/09/2021 TachoSil - EMEA/H/C/000505 - T/0112
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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TachoSil is indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, for suture support in vascular surgery where standard techniques are insufficient, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 - 23 February 202324/02/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 201626/02/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 201216/11/2012