TachoSil

RSS

human fibrinogen / human thrombin

Authorised
This medicine is authorised for use in the European Union.

Overview

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 22/09/2021

Authorisation details

Product details
Name
TachoSil
Agency product number
EMEA/H/C/000505
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
B02BC30
Publication details
Marketing-authorisation holder
Corza Medical GmbH
Revision
24
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

15/09/2021 TachoSil - EMEA/H/C/000505 - T/0112

Other EU languages available icon 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 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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