human fibrinogen / human thrombin
TachoSil is a sponge sealant patch used in adults and children from 1 month of age:
- during an operation, to stop bleeding and seal the surfaces of internal organs;
- as a support to stitching during surgery on blood vessels when standard techniques are not sufficient.
TachoSil is also used in adults during neurological surgery to seal the dura mater (a membrane that surrounds and protects the brain) to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).
The TachoSil patch is coated with the active substances human fibrinogen and human thrombin.
TachoSil : EPAR - Summary for the public (PDF/136.39 KB)
First published: 25/06/2009
Last updated: 12/05/2023
TachoSil : EPAR - Risk management plan summary (PDF/164.95 KB)
First published: 12/05/2023
|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
24/03/2023 TachoSil - EMEA/H/C/000505 - II/0117
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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 and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. TachoSil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).
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