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TYPHIM Vi 0.025mg/0.5mL salmonella typhi vi polysaccharide vaccine injection syringe, Sanofi-Aventis Australia Pty Ltd, CON-355
Product name
TYPHIM Vi 0.025mg/0.5mL salmonella typhi vi polysaccharide vaccine injection syringe
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Batches
R2A241M
Consent start
Consent no.
CON-355
Duration
The consent is effective from 29 January 2020 until 30 April 2021.
Standard
Paragraphs 10(5)(c), 10(5)(g) and 10(5)(h) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The containers (syringes) are labelled with Standard International labelling rather than the Australian approved container label.The Standard International syringe label does not comply with TGO 91 in the following respectsText size for the name of the medicine and for the other information contained on the label.The approved route of administration in Australia is 'IM injection only' but the international label states 'SC/IM'.The proportion of the active ingredient in the medicine is not stated.
Conditions imposed
This consent only applies toTYPHIM Vi, Batch R2A241M, Expiry 30 April 2021, Quanity 62041 doses.
A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 28 January 2020 will be supplied with the affected batch warning that the Standard International syringe label does not fully comply with the Australian labelling requirements.
All other packaging and labelling of the product, including carton labels and package leaflet (Australian Product Information and Consumer Information), will comply with current Australian registered details.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines