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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
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.
Therapeutic product type
Prescription medicines