human fibrinogen / human thrombin

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 12/05/2023

Authorisation details

Product details
Agency product number
Active substance
  • human fibrinogen
  • human thrombin
International non-proprietary name (INN) or common name
  • human fibrinogen
  • human thrombin
Therapeutic area (MeSH)
Hemostasis, Surgical
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Corza Medical GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Corza Medical GmbH
Speditionsstrasse 21
40221 Dusseldorf

Product information

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).

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


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).

Assessment history

Changes since initial authorisation of medicine

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