TachoSil

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Questions & Answers

On 25 February 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product TachoSil. The marketing authorisation holder for this medicinal product is Takeda Austria GmbH.

The CHMP adopted a new indication as follows*:

“TachoSil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery”.

For information, the full indication for TachoSil will be as follows:

“TachoSil is indicated in adults 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, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


*New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for TachoSil (English only) 2016-02-26  

Key facts

Product details for TachoSil
NameTachoSil
INN or common name

human fibrinogen / human thrombin

Therapeutic area Hemostasis, Surgical
Active substance

human fibrinogen / human thrombin

Date opinion adopted25/02/2016
Company name

Takeda Austria GmbH

StatusPositive
Application typePost authorisation