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Verorab
Sponsor
Device/Product name
Verorab
Active Ingredient
Inactivated rabies virus
Date of decision
Published
Submission type
New biological entity
ATC codes
J07BG01
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 Verorab 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.
|
Description |
Date |
|
Submission dossier accepted and first round evaluation commenced |
30 September 2021 |
|
First round evaluation completed |
16 May 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
6 June 2022 |
|
Second round evaluation completed |
20 June 2022 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
7 July 2022 |
|
Sponsor’s pre-Advisory Committee response |
19 July 2022 |
|
Advisory Committee meeting |
3 August 2022 |
|
Registration decision (Outcome) |
6 October 2022 |
|
Completion of administrative activities and registration on ARTG |
17 October 2022 |
|
Number of working days from submission dossier acceptance to registration decision* |
210 |
*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
Powder and solvent for suspension for injection.
Strength
3.25 intenational units (IU) of rabies antigen
Other ingredients
Maltose, 20% albumin solution, basal medium eagle (mixture of mineral salts, vitamins, dextrose and amino acids including L Phenylalanine), sodium chloride, hydrochloric acid and/or sodium hydroxide (for pH adjustment) and water for injections. Note: neomycin, streptomycin and polymyxin may be present in trace amounts.
Containers
Vial with diluent pre-filled syringe with attached needle
Pack sizes
1 and 10
Routes of administration
Intramuscular or intradermal
Dosage
The dose and dosing schedule is identical for adults and paediatric population. The vaccine is administered by intramuscular (IM) injection, in the deltoid area for adults and children or the anterolateral area of the thigh muscle in infants and toddlers. The dose depends on the route of administration and if it is a pre-exposure or post-exposure prophylaxi treatment.
For further information refer to the Product Information.
Pregnancy category
B2
Drugs 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.
Drugs 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
Verorab (inactivated rabies virus) was approved for the following therapeutic use:
Verorab is indicated for pre-exposure prophylaxis against rabies.
Verorab is indicated for post-exposure prophylaxis against rabies.
Verorab should be used in accordance with official local recommendations.
What is this medicine and how does it work
Protection after vaccination is provided by the induction of rabies neutralising antibodies.
What post-market commitments will the sponsor undertake
- Verorab is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Verorab 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 Verorab EU [European Union] -risk management plan (RMP) (version 2.1, dated 3 March 2020, data lock point 1 January 2020), with Australia specific annex (version 1.0, dated 30 July 2021), included with Submission PM-2021-03191-1-2, 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).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
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 (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- The sponsor must not import or supply the product without compliance with the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines, or without a relevant exemption.
- As agreed by the sponsor, the details of the manufacturing processing and purification steps with viral clearance capacity, or any validation studies using model viruses according to Section 6.1.1 of ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] Q5A (R1) and CPMP /BWP/268/95 [Committee for Proprietary Medicinal Products] must be provided by the end of 2023.
- All GMP [Good Manufacturing Practices] clearances must be approved prior to registration and supply of product to Australia. A commitment is required from the sponsor that they maintain the validity of all manufacturer GMP Clearances for the duration of product supply to Australia. Additionally, that adherence to the conditions of GMP clearance approval is upheld.
- Additional data relating to the ongoing stability study for the concentrated bulk drug substance will be submitted
- It is a condition of registration that all independent batches of Verorab vaccine imported into Australia are not released for sale until samples and the manufacturer’s release data have been assessed and you have received notification acknowledging release from the Laboratories Branch, TGA.
For each independent batch of the product imported into Australia, the sponsor must supply the following:
- A completed Request for Release Form, available from vaccines@health.gov.au.
- Complete summary protocols for manufacture and QC [Quality Control], including all steps in production in the agreed format.
- At least 5 (five) vials (samples) of each manufacturing batch of Verorab vaccine with the Australian approved labels, PI and packaging (unless an exemption to supply these has been granted) representative of all batches of product seeking distribution in Australia.
- At least 1 (one) vial (samples) of any further consignments of a manufacturing batch of Verorab vaccine with the Australian approved labels, PI and packaging (unless an exemption to supply these has been granted). Further consignments cover batches previously supplied to TGA for the purposes of batch release testing but are seeking to be supplied again.
- If the manufacturing batch has been released in Europe or United Kingdom a copy of the EU Official Control Authority Batch Release (OCABR) certificate (or equivalent from the UK) must be provided.
- Any reagents, reference material and standards required to undertake testing, as requested by Laboratories Branch, TGA.
Sponsors must provide all requested Samples and data in sufficient time (at least 5 business days) prior to any distribution date to allow the TGA to perform testing and review. Distribution of each batch of vaccine is conditional upon fulfilment of these conditions and receipt of a letter from the Laboratories Branch acknowledging release.
Samples and data should be forwarded to the Biotherapeutics Section, Laboratories Branch before release of each batch and with sufficient lead time to allow for Laboratories Branch testing.
The shipments (including reagents) to TGA are the responsibility of the Australian sponsor/agent who will be required to facilitate the import and customs clearance process.
- For all injectable products the Product Information must be included with the product as a package insert