Is Human fibrinogen human thrombin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Human fibrinogen human thrombin: VeraSeal.

Are there safety signals or safety updates for Human fibrinogen human thrombin?

EMA PRAC: 3 entries (latest 2015-12-03).

Active substance

Human fibrinogen human thrombin

EMA 1
Safety 3

Open in the medicines table

EMA European Union — centrally authorised medicines

VeraSeal Instituto Grifols, S.A. · Authorised · authorised 10 Nov 2017 · ATC B02BC

Therapeutic indication (EMA)

Supportive treatment in adults where standard surgical techniques are insufficient: for improvement of haemostasis as suture support in vascular surgery

Safety signals and safety-related labeling changes

EMA PRAC 3 Dec 2015 PRAC signal: Intestinal obstruction
Action for MAH: update of the product information: Yes
EMA PRAC 6 Nov 2015 PRAC signal: Intestinal obstruction
Action for MAH: update of the product information: No
EMA PRAC 9 Jul 2015 PRAC signal: Intestinal obstruction
Action for MAH: update of the product information: No

All safety entries for human fibrinogen human thrombin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.