LUCENTIS ranibizumab (rbe) 1.65 mg/0.165 mL solution for injection prefilled syringe, Novartis Pharmaceuticals Australia Pty Ltd, CON-1441
Product name
LUCENTIS ranibizumab (rbe) 1.65 mg/0.165 mL solution for injection prefilled syringe
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
ARTG details
AUST R 212387
Consent start
Consent no.
CON-1441
Duration
The consent is effective from 22 December 2025 until 30 June 2026.
Standard
Subsection 8(1) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not comply as the package insert included in the pack of the
products will contain an earlier version of the approved Product Information
(PI).
Conditions imposed
A ‘Dear Healthcare Professional’ letter identical to that provided to the
TGA will be provided to healthcare professionals via direct communication to
access the latest approved version of the PI on the TGA website and the Novartis
company website.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines