TachoSil
human fibrinogen / human thrombin
Table of contents
Overview
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.
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List item
TachoSil : EPAR - Summary for the public (PDF/136.39 KB)
First published: 25/06/2009
Last updated: 12/05/2023
EMA/110851/2023 -
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List item
TachoSil : EPAR - Risk management plan summary (PDF/164.95 KB)
First published: 12/05/2023
Authorisation details
Product details | |
---|---|
Name |
TachoSil
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Agency product number |
EMEA/H/C/000505
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Hemostasis, Surgical
|
Anatomical therapeutic chemical (ATC) code |
B02BC30
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Publication details | |
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Marketing-authorisation holder |
Corza Medical GmbH
|
Revision |
25
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Date of issue of marketing authorisation valid throughout the European Union |
08/06/2004
|
Contact address |
Corza Medical GmbH
Speditionsstrasse 21 40221 Dusseldorf Germany |
Product information
24/03/2023 TachoSil - EMEA/H/C/000505 - II/0117
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antihemorrhagics
Therapeutic indication
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).