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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-1369
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
554673
Consent start
Consent no.
CON-1369
Duration
The consent is effective from 18 June 2025 until 11 February 2030.
Standard
Subparagraph 7(1)(d)(i), paragraph 8(1)(i) and paragraph 8(1)(o)
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not comply because it is supplied with FDA-approved labelling
that does not include: • 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 labels of ACAM2000 smallpox vaccine (live vaccinia virus)
vial with diluent [AUST R 153108].
2. The diluent batch 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