VeraSeal

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On 14 September 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product VeraSeal, intended for use as a sealant during surgical operations in adults. The applicant for this medicinal product is Instituto Grifols, S.A.

VeraSeal (ATC code: B02BC) will be available as solutions containing the active substances human fibrinogen (80 mg/ml) and human thrombin (500 IU/ml). When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin. The fibrin then aggregates and forms a fibrin clot that helps the wound to heal, preventing bleeding.

The benefits of VeraSeal are its ability to help the wound to heal, preventing bleeding. The most common side effects are procedural pain, nausea, pruritus and pyrexia.

The full indication is:

"Supportive treatment in adults where standard surgical techniques are insufficient:

  • for improvement of haemostasis.
  • as suture support in vascular surgery."

It is proposed that the use of VeraSeal is restricted to experienced surgeons who have been trained in the use of the medicinal product.

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

Name Language First published Last updated
CHMP summary of positive opinion for VeraSeal (English only) 2017-09-15  

Key facts

Product details for VeraSeal
NameVeraSeal
INN or common namehuman fibrinogen / human thrombin
Therapeutic area Hemostasis, Surgical
Active substance

human fibrinogen, human thrombin

Date opinion adopted14/09/2017
Company name

Instituto Grifols, S.A.

StatusPositive
Application typeInitial authorisation