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ROTARIX human rotavirus (live attenuated oral vaccine) oral liquid tube, GlaxoSmithKline Australia Pty Ltd, CON-1426
Product name
ROTARIX human rotavirus (live attenuated oral vaccine) oral liquid tube
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Consent start
Consent no.
CON-1426
Duration
The consent is effective from 4 November 2025 until 5 November 2026.
Standard
Section 6, Paragraph 8(1)(d) and Paragraph 8(1)(j) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because: - The carton labels include the excipient
name ‘Di-sodium adipate’, which is not the Australian Approved Name (AAN) for
the ingredient. - The dosage form on the carton labels is stated as ‘Oral
suspension in tube’, which does not match the dosage form registered in the ARTG
for this product, namely ‘Oral Liquid, suspension’. - Phenylalanine which is a
component of Dulbecco’s Modified Eagle Medium used in the product, is a
declarable substance and it is not declared on the carton labels.
Conditions imposed
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines