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 26/07/2018

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
Takeda Austria GmbH
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
08/06/2004
Contact address

St. Peter Strasse 25
A-4020 Linz
Austria

Product information

25/05/2018 TachoSil - EMEA/H/C/000505 - IA/0088

Contents

  • 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

Antihaemorrhagics

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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