JESPECT japanese encephalitis virus purified inactivated vaccine 0.5 mL suspension for injection syringe, Seqirus (Australia) Pty Limited, CON-597
Product name
JESPECT japanese encephalitis virus purified inactivated vaccine 0.5 mL suspension for injection syringe
Sponsor name
Seqirus (Australia) Pty Limited
Batches
Batch JEV19J25D
Consent start
Consent no.
CON-597
Standard
Paragraph 10(3)(a) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The excipient names on the label and product information do not align with the
Australian Approved Names (AAN), specifically Excipient names on label and
product information aluminium hydroxide Phosphate Buffered Saline disodium
hydrogen phosphate potassium dihydrogen phosphate sodium chloride Excipient AANs
aluminium hydroxide hydrate dibasic sodium phosphate monobasic potassium
phosphate sodium chloride
Conditions imposed
1. This consent applies only to JESPECT japanese encephalitis virus purified
inactivated vaccine 0.5mL suspension for injection syringe [150602] batch
JEV19J25D (expiry February 2022) for release in the Australian market; and 2.
Non-compliance with the Therapeutic Goods Order 91 is limited to the information
detailed in the submission.
Therapeutic product type
Prescription medicines