TachoSil
Opinion
On 23 February 2023, 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 Corza Medical GmbH.
The CHMP adopted an extension to existing indication as follows1:
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).
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.
1New text in bold
Key facts
| Name |
TachoSil |
| Agency product number |
EMEA/H/C/000505 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Hemostasis, Surgical
|
| Date opinion adopted |
23/02/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |