VeraSeal

human fibrinogen / human thrombin

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This is a summary of the European public assessment report (EPAR) for VeraSeal. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use VeraSeal.

For practical information about using VeraSeal, patients should read the package leaflet or contact their doctor or pharmacist. 

What is VeraSeal and what is it used for?

VeraSeal is a sealant (glue) used to stop bleeding during surgery or to support stitches during surgery on blood vessels.

VeraSeal is used when standard surgery techniques do not work well enough. It contains the active substances human fibrinogen and human thrombin.

How is VeraSeal used?

VeraSeal should only be used by an experienced surgeon who has been trained in its use. It is available as two prefilled syringes in a syringe holder, one containing a solution of human fibrinogen (80 mg/ml), and the other containing a solution of human thrombin (500 international units/ml). Before use, the syringes are attached to a device supplied with the medicine that allows their contents to mix as they are dripped or sprayed on the wound. The amount of VeraSeal to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.

How does VeraSeal work?

The active substances in VeraSeal, fibrinogen and thrombin, are substances present in human plasma (the liquid part of the blood), which are involved in the normal blood clotting process.

When the two active substances are mixed, thrombin cuts fibrinogen up into fibrin. The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.

What benefits of VeraSeal have been shown in studies?

Three main studies in 614 patients found that VeraSeal is effective at stopping bleeding within 4 minutes of applying it during surgery.

In one study of blood vessel surgery, VeraSeal worked better than manual compression, with 76% of patients having no bleeding 4 minutes after treatment with VeraSeal (83 out of 109), compared with 23% after manual compression (13 out of 57).

In a second study of organ surgery, VeraSeal was as effective as another product Surgicel: 93% of the patients had no bleeding 4 minutes after treatment with VeraSeal (103 out of 111), while 81% of the patients had no bleeding with Surgicel (91 out of 113).

Finally, in a third study of soft tissue surgery, VeraSeal was as effective as Surgicel: 83% of the patients had no bleeding 4 minutes after treatment with VeraSeal (96 out of 116), compared with 78% of the patients after treatment with Surgicel (84 out of 108).

What are the risks associated with VeraSeal?

The most common side effects with VeraSeal (which may affect up to 1 in 10 people) are nausea (feeling sick), pruritus (itchiness) and procedural pain (pain from the surgery). Rarely, VeraSeal may cause an allergic reaction which can be severe especially when the medicine is used repeatedly. In rare cases, patients have developed antibodies to the proteins in VeraSeal, which could interfere with blood clotting. Thromboembolic complications (blood clots) may occur if VeraSeal is accidentally injected into a blood vessel. Cases of gas embolism (gas bubbles that block blood flow) have occurred when such sealants were applied as spray.

VeraSeal must not be used intravascularly (inside blood vessels) or to treat heavy bleeding of the arteries. VeraSeal must not be applied by spraying during endoscopy (a procedure that uses a tube for viewing inside the body).

For the full list of all side effects and restrictions with VeraSeal, see the package leaflet.

Why is VeraSeal approved?

VeraSeal has been shown to effectively stop bleeding during surgery, which can be expected to reduce blood loss, reduce time in the operating theatre and possibly shorten hospital stays. Although patients could develop antibodies against the medicine, which might reduce its effectiveness, this has not been seen in the studies.

As for all medicines obtained from blood, infections could be transmitted with the medicine; however, the medicine is manufactured using filtration and a process to inactivate viruses that minimise this risk. The observed side effects were as expected with major surgeries or the patient’s condition. The European Medicines Agency therefore decided that VeraSeal’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of VeraSeal?

The company that markets VeraSeal will provide educational materials for healthcare professionals with information on how to use the medicine safely when it is applied by spraying.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of VeraSeal have also been included in the summary of product characteristics and the package leaflet.

Other information about VeraSeal

The European Commission granted a marketing authorisation valid throughout the European Union for VeraSeal on 10 November 2017.

For more information about treatment with VeraSeal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
VeraSeal : EPAR - Summary for the public BG = bălgarski 2018-01-17  
VeraSeal : EPAR - Summary for the public ES = español 2018-01-17  
VeraSeal : EPAR - Summary for the public CS = čeština 2018-01-17  
VeraSeal : EPAR - Summary for the public DA = dansk 2018-01-17  
VeraSeal : EPAR - Summary for the public DE = Deutsch 2018-01-17  
VeraSeal : EPAR - Summary for the public ET = eesti keel 2018-01-17  
VeraSeal : EPAR - Summary for the public EL = elliniká 2018-01-17  
VeraSeal : EPAR - Summary for the public EN = English 2018-01-17  
VeraSeal : EPAR - Summary for the public FR = français 2018-01-17  
VeraSeal : EPAR - Summary for the public IT = italiano 2018-01-17  
VeraSeal : EPAR - Summary for the public LV = latviešu valoda 2018-01-17  
VeraSeal : EPAR - Summary for the public LT = lietuvių kalba 2018-01-17  
VeraSeal : EPAR - Summary for the public HU = magyar 2018-01-17  
VeraSeal : EPAR - Summary for the public MT = Malti 2018-01-17  
VeraSeal : EPAR - Summary for the public NL = Nederlands 2018-01-17  
VeraSeal : EPAR - Summary for the public PL = polski 2018-01-17  
VeraSeal : EPAR - Summary for the public PT = português 2018-01-17  
VeraSeal : EPAR - Summary for the public RO = română 2018-01-17  
VeraSeal : EPAR - Summary for the public SK = slovenčina 2018-01-17  
VeraSeal : EPAR - Summary for the public SL = slovenščina 2018-01-17  
VeraSeal : EPAR - Summary for the public FI = suomi 2018-01-17  
VeraSeal : EPAR - Summary for the public SV = svenska 2018-01-17  
VeraSeal : EPAR - Summary for the public HR = Hrvatski 2018-01-17  

This EPAR was last updated on 17/01/2018 .

Authorisation details

Product details

Product details for VeraSeal
NameVeraSeal
Agency product numberEMEA/H/C/004446
Active substance

human fibrinogen, human thrombin

International non-proprietary name (INN) or common name

human fibrinogen / human thrombin

Therapeutic area Hemostasis, Surgical
Anatomical therapeutic chemical (ATC) code B02BC
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for VeraSeal
Marketing-authorisation holder

Instituto Grifols, S.A.

Revision0
Date of issue of marketing authorisation valid throughout the European Union10/11/2017

Contact address:

Poligono Levante
c/Can Guasc 2
Barcelona 08150
Parets del Valles
Spain

Product information

Product information

10/11/2017  VeraSeal -EMEA/H/C/004446 --

Name Language First published Last updated
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - Product Information HR = Hrvatski 2018-01-17  

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.


Name Language First published Last updated
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
VeraSeal : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Supportive treatment in adults where standard surgical techniques are insufficient:

- for improvement of haemostasis.

-  as suture support in vascular surgery

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
VeraSeal : EPAR - Public assessment report HR = Hrvatski 2018-01-17  
CHMP summary of positive opinion for VeraSeal HR = Hrvatski 2017-09-15  

Authorised

This medicine is approved for use in the European Union