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-221
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-221
Standard
Subclause 3(2)(b), 3(2)(l) 3(13)(a) of the Therapeutic Goods Order No. 69- General requirements for labels for medicine
Non-compliance with standard
The proposed blister foil for the 75,000 SQ-T tablets does not include the name
of the active ingredient (Phleum pratense); and the Seqirus name or trademark.
Conditions imposed
The 'blister foil for the 75,000 SQ-T tablets' labels to which the consent
applies are those provided with the responses to S31-PM-2015-03979-1-2 (dated 30
August 2016).
Therapeutic product type
Prescription medicines