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ACAM2000 smallpox vaccine (live vaccinia virus) vial with diluent, PPD Australia Pty Ltd (on behalf of Emergent Sales and Marketing Australia Pty Ltd), CON-1362
Product name
ACAM2000 smallpox vaccine (live vaccinia virus) vial with diluent
Sponsor name
PPD Australia Pty Ltd (on behalf of Emergent Sales and Marketing Australia Pty Ltd)
Batches
Diluent lot 533748, with expiry date 4 September 2029
Consent start
Consent no.
CON-1362
Duration
The consent is effective from 5 June 2025 until 4 September 2029.
Standard
section 7(1)(d)(i); section 8(1)(i); section 8(1)(o) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not comply for the following: • AUST R number is not stated on
the labels • Name and address of the current Sponsor or supplier of the goods –
Labels include the manufacturer details but not the Australia Sponsor. • Name of
the diluent is only on the front panel of the carton label, where it should be
shown on three (3) non-opposing sides of the carton (box).
Conditions imposed
1. Applies only to the diluent of ACAM2000 smallpox vaccine (live vaccinia
virus) vial with diluent [AUST R 153108].
2. The diluent batch outlined will only be imported and supplied for the
National Medical Stockpile held by the Australian Government Department of
Health, Disability and Ageing.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Blood, tissues, and biologicals