Raniviz
Registration timeline
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced | 3 January 2023
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 4 September 2023
|
Advisory Committee meeting | Not applicable
|
Registration decision (Outcome) | 12 December 2023
|
Completion of administrative activities and registration on ARTG | 20 December 2023 |
Number of working days from submission dossier acceptance to registration decision* | 134
|
* The COR-B process has a 175 working day evaluation and decision timeframe.
Raniviz must be administered by a qualified ophthalmologist experienced in intravitreal injections.
The recommended dose for Raniviz in adults is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 mL. The interval between two doses injected into the same eye should be at least four weeks.
The recommended maximal dose (0.5 mg) should not be exceeded. Post-injection monitoring is recommended (see Section 4.4 Special Warnings and Precautions for Use of the Product Information).
For further information refer to the Product Information.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database 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.
Raniviz (ranibizumab) was approved for the following therapeutic use:
Raniviz (ranibizumab) is indicated in adults for:
- the treatment of neovascular (wet) age-related macular degeneration (AMD),
- the treatment of visual impairment due to diabetic macular oedema (DME),
- treatment of proliferative diabetic retinopathy (PDR),
- the treatment of visual impairment due to choroidal neovascularisation,
- the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM),
- the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).
Not recommended for use in preterm infants.
Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A). It binds with high affinity to the VEGF-A isoforms (for example, VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR1 and VEGFR-2.
Binding of VEGF-A to its receptors leads to endothelial cell proliferation and neovascularisation, as well as vascular leakage, which are thought to contribute to the progression of the neovascular form of age-related macular degeneration, to the development of choroidal neovascularisation (CNV), including CNV secondary to pathologic myopia or to the macular oedema causing visual impairment in diabetes and retinal vein occlusion.
- The ranibizumab (rbe) European Union (EU)-risk management plan (RMP) (version 1.0, dated 8 June 2022, data lock point 14 June 2021), with Australia-specific annex (version 0.2, dated 12 May 2023), included with Submission PM-2022-04707-1-5, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
- Laboratory testing and compliance with Certified Product Details (CPD)
- All batches of Raniviz 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.
- Certified Product Details
The Certified Product Details (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. A template for preparation of CPD for biological prescription medicines can be obtained from the TGA website [for the form] [for the CPD guidance].
Further information
The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.