human fibrinogen / human thrombin

This medicine is authorised for use in the European Union.


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).

This EPAR was last updated on 07/01/2020

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
Takeda Austria GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

St. Peter Strasse 25
A-4020 Linz

Product information

06/12/2019 TachoSil - EMEA/H/C/000505 - IA/0099


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group


Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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