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TRAVACALM H.O. Chewable hyoscine hydrobromide 300 micrograms tablet strip pack, Key Pharmaceuticals Pty Ltd, CON-1052
Product name
TRAVACALM H.O. Chewable hyoscine hydrobromide 300 micrograms tablet strip pack
Sponsor name
Key Pharmaceuticals Pty Ltd
Batches
PB10670 and PB10671
Consent start
Consent no.
CON-1052
Duration
The consent is effective from 1 January 2023 until 31 December 2024.
Standard
subsection 10(4) of Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021
Non-compliance with standard
The products do not comply as the carton label includes a 2D data matrix code;
however, the human readability formatting requirements are not compliant because
the Global Trade Item Number (GTIN) and serial number are only identified by the
application identifier (01) and (21) instead of GTIN and S/N.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Over-the-counter medicines