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VeraSeal
Sponsor
ARTGs
335950, 336835, 336836, 336837
335950, 336835, 336836, 336837
335950, 336835, 336836, 336837
335950, 336835, 336836, 336837
Device/Product name
VeraSeal
Active Ingredient
Human fibrinogen/human thrombin
Date of decision
Published
Submission type
New biological entity
ATC codes
B02BC
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium, with work-sharing between TGA, Health Canada and Swissmedic. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 June 2020 |
| First round evaluation completed | 27 November 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 9 February 2021 |
| Second round evaluation completed | 26 March 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 23 July 2021 |
| Sponsor's pre-Advisory Committee response | 10 September 2021 |
| Advisory Committee meeting | 30 September and 1 October 2021 |
| Registration decision (Outcome) | 29 October 2021 |
| Completion of administrative activities and registration on ARTG | 2 and 3 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 251 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
Solutions for sealant
Strength
80 mg/mL human fibrinogen and 500 IU/mL human thrombin
Other ingredients
Sodium citrate dihydrate, sodium chloride, arginine, isoleucine, monosodium glutamate monohydrate, and water for injections (human fibrinogen syringe).
Calcium chloride, human albumin, sodium chloride, glycine, and water for injections (human thrombin syringe).
Containers
Syringe
Pack sizes
2 mL (1mL human fibrinogen and 1mL human thrombin)4 mL (2mL of human fibrinogen and 2mL human thrombin)6 mL (3mL human fibrinogen and 3mL human thrombin)10 mL (5mL human fibrinogen and 5mL human thrombin)
Routes of administration
Epilesional
Dosage
The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of this medicinal product.
The volume of VeraSeal to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient.
The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
Application of the product must be individualised by the treating physician. In clinical trials, the individual dosages have typically ranged from 0.3 to 12 mL. For other procedures, larger volumes may be required.
The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area. The application can be repeated, if necessary.
Paediatric population
The safety and efficacy of VeraSeal in children aged 0 to 18 years has not yet been established. Currently available data are described in Section 5.1 of the Product Information, but no recommendation on a posology can be made.
For further information refer to the Product Information.
Pregnancy category
B2Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
- VeraSeal (human fibrinogen/human thrombin) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for VeraSeal must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The VeraSeal European Union (EU)-risk management plan (RMP) (version 4.1, dated 21 October 2019, data lock point 8 June 2018), with Australian Specific Annex (version 3.0, dated 12 April 2021), included with submission PM-2020-01828-1-6, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- Additional conditions:
All batches of VeraSeal supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
The CPD, as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
The CPD should be emailed post approval to biochemistry.testing@health.gov.au as a single PDF document.
Any changes to the VeraSeal fibrinogen manufacturing process post-approval that potentially result in further removal of endogenous fibrin stabilising factor (FXIII) must be submitted to the TGA as a Category 3 application with justification (including supporting data) as to why the change will not affect product quality.