INFANRIX HEXA injection composite pack (pre-filled syringe and vial), GlaxoSmithKline Australia Pty Ltd, CON-426
Product name
INFANRIX HEXA injection composite pack (pre-filled syringe and vial)
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-426
Standard
Paragraph 10(3)(a) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The excipients names on the label, aluminium hydroxide, lactose andpotassium
phosphate monobasic, do not align with the Australian Approved Name (AAN)
Conditions imposed
1.Non-compliance with Therapeutic Goods Order 91 (TGO 91) is limited to
theinformation detailed in the submission.2. The non-compliant labels will be
revised to become fully compliant with TGO91 on or before 11 May 2021; and3.
This exemption applies only to productsreleased in the Australian marketbefore
11 May 2021.
Therapeutic product type
Prescription medicines