GRAZAX standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T oral lyophilisate tablets blister foil, Seqirus Pty Ltd, CON-356
Product name
GRAZAX standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T oral lyophilisate tablets blister foil
Sponsor name
Seqirus Pty Ltd
Consent start
Consent no.
CON-356
Duration
The consent is effective from the 29 January 2020 until 1 March 2022.
Standard
Subsection 8(2), paragraphs 8(1)(o) and 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 (TGO No. 91)
Non-compliance with standard
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 (Phleum pratense) do not appear in a cohesive unit.
The name of the active ingredient (phleum pratense) is not included.
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 on 24 February 2017.
Import, Supply, &/or Export
Import, supply and export
Therapeutic product type
Prescription medicines