JESPECT japanese encephalitis virus purified inactivated vaccine 0.5mL suspension for injection syringe, Seqirus Pty Limited, CON-878
Product name
JESPECT japanese encephalitis virus purified inactivated vaccine 0.5mL suspension for injection syringe
Sponsor name
Seqirus Pty Limited
Batches
JEV19F14D (4311 doses) and JEV19J25D (4545 doses)
Consent start
Consent no.
CON-878
Standard
Paragraphs 8(3)(e) and 10(5)(f) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product packaging does not conform with the requirements of Paragraphs
8(3)(e) and 10(5)(f) of Therapeutic Goods Order No. 91 '“ Standard for labels of
prescription and related medicines (TGO 91) in that the carton, blister tray and
syringe labels include an incorrect expiry date.
Conditions imposed
1. A 'Dear Immuniser' letter (as per the copy provided with the application
from Seqirus Pty Limited) will be supplied with each unit in the affected
batches outlining the non-compliance in the product labelling (discrepancy
in expiry dates).
2. An explanatory letter to customers (i.e. wholesalers and pharmacists), as
per the copy provided with the application from Seqirus Pty Limited,
detailing the proposed changes, providing directions on where further
information can be obtained (e.g. websites) and how replacement product can
be obtained, will be distributed.
3. Over-labelling will be performed at a registered secondary packaging site
for the carton labels to include the correct expiry date.
4. A record of maintenance of the approved storage conditions for Jespect (i.e.
2„ƒ to 8„ƒ) during the over-labelling process, including transport, will be
provided to TGA as per the email from Seqirus Pty Limited dated 19
October 2021.
Therapeutic product type
Prescription medicines