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ACARIZAX Standardised allergen extract from American house dust mite extract European house dust mite extract 12 SQ-HDM sublingual tablet, Seqirus Pty Ltd, CON-904
Product name
ACARIZAX Standardised allergen extract from American house dust mite extract European house dust mite extract 12 SQ-HDM sublingual tablet
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-904
Duration
The consent is effective for all batches from 27 January 2022 until 6 February 2024.
Standard
Subparagraphs 10(14)(a)(v) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO91)
Non-compliance with standard
The product does not conform to the requirements of subparagraphs 10(14)(a)(v)
and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 – Standard for labels of
prescription and related medicines (TGO91), in that The name of the active
ingredient (American house dust mite extract amp; European house dust mite
extract) is not included.The name of the sponsor is not included.
Conditions imposed
The ACARIZAX label exempted from TGO 91 requirements is identical to that
approved by the Therapeutic Goods Administration and presented with the
submission.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines