LEQEMBI lecanemab 200 mg/2 mL concentrated injection vial, Eisai Australia Pty Ltd , CON-1461
Product name
LEQEMBI lecanemab 200 mg/2 mL concentrated injection vial
Sponsor name
Eisai Australia Pty Ltd
Batches
8162445
Consent start
Consent no.
CON-1461
Duration
The consent is from 9 April 2026 until 1 January 2027.
Standard
subsection 8(1)(n) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product label does not have a machine-readable code on the carton.
Conditions imposed
Pharmacies will be advised that there is no machine-readable code on the carton
label of the affected batch.
Pharmacies will be advised to process any stock of the affected batch manually.
No product will be distributed through wholesalers and the Sponsor will have
direct contact with the pharmacies.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines