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GRAZAX standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T sublingual tablets blister foil, Seqirus Pty Ltd, CON-906
Product name
GRAZAX standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T sublingual tablets blister foil
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-906
Duration
The consent is effective from 31 January 2022 until 1 March 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 (phleum pratense) is not included and the name of the sponsor is not
included.
Conditions imposed
The GRAZAX label exempted from TGO 91 is identical to that has been approved by
the TGA and presented with the submission.
Import, Supply, &/or Export
Import, supply and export
Therapeutic product type
Prescription medicines