ACARIZAX standardised allergen extract from house dust mites D. pteronyssinus and D. farinae 12 SQ-HDM oral lyophilisate tablet blister pack, Seqirus Pty Ltd, CON-368
Product name
ACARIZAX standardised allergen extract from house dust mites D. pteronyssinus and D. farinae 12 SQ-HDM oral lyophilisate tablet blister pack
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-368
Standard
Subsection 8(2), paragraphs 8(1)(j), 8(1)(o), 9(3)(a) and, subparagraphs 10(14)(a)(v) and 10(14)(a)(ix) in the Therapeutic Goods Order No.91 '“ Standard for labels of prescription and related medicines
Non-compliance with standard
CartonThe warning statement 'contains fish' is not on the carton.The name of the
medicine is not on three non-opposing sides of the carton.The dispensing label
space is smaller than 70×30 millimetres.The name of the medicine and the name of
the active ingredient (American house dust mite extract European house dust mite
extract) do not appear in a cohesive unit.Blister foilThe name of the active
ingredient (American house dust mite extract 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 is identical to approved by the TGA and
presented with this submission.
Therapeutic product type
Prescription medicines