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VeraSeal
Published
Product name
VeraSeal
Active ingredient
Human fibrinogen/human thrombin
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
VeraSeal (human fibrinogen/human thrombin) was approved for the following therapeutic use:
VeraSeal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.
How this medicine works
The fibrin adhesion system initiates the last phase of physiological blood coagulation. Thrombin cleaves fibrinogen into fibrin monomers and fibrinopeptides. The fibrin monomers aggregate and form a fibrin clot. Factor XIIIa, which is activated from factor XIII by thrombin, crosslinks fibrin. Calcium ions are required for both the conversion of fibrinogen and the cross-linkage of fibrin.As wound healing progresses increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of VeraSeal was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- VeraSeal solutions for sealant 2 mL (Human fibrinogen 80 mg/mL syringe 1 mL / Human thrombin 500 IU/mL syringe 1 mL) (335950)
- VeraSeal solutions for sealant 4 mL (Human fibrinogen 80 mg/mL syringe 2 ml / Human thrombin 500 IU/mL syringe 2 ml) (336835)
- VeraSeal solutions for sealant 6 mL (Human fibrinogen 80 mg/mL syringe 3 ml / Human thrombin 500 IU/mL syringe 3 ml) (336836)
- VeraSeal solutions for sealant 10 mL (Human fibrinogen 80 mg/mL syringe 5 ml / Human thrombin 500 IU/mL syringe 5 ml) (336837)