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IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial, Biocelect Pty Ltd, CON-1296
Product name
IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial
Sponsor name
Biocelect Pty Ltd
Batches
U7042 and U7043
Consent start
Consent no.
CON-1296
Duration
The consent is effective from 15 November 2024 until 15 November 2030.
Standard
'Test for extraneous agents in cell cultures in Table 2.6.16.-1 – Relevant tests for extraneous agents at various production stages' in Ph. Eur. 2.6.16 of European Pharmacopoeia
Non-compliance with standard
Adventitious agent testing of the Drug Substance as an in-process control at the
pre-infection stage for two drug substance batches (U7042 and U7043) is not
performed which is a requirement of Ph. Eur. 2.6.16 of European Pharmacopoeia.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Blood, tissues, and biologicals