TYPHIM Vi 0.025 mg/0.5 mL salmonella typhi vi polysaccharide vaccine injection syringe, Sanofi-Aventis Australia Pty Ltd, CON-382
Product name
TYPHIM Vi 0.025 mg/0.5 mL salmonella typhi vi polysaccharide vaccine injection syringe
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Batches
T2A421M
Consent start
Consent no.
CON-382
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
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 because ' 10(5)(c) '“ Text size for the name of the
medicine and for the other information contained on the label ' 10(5)(g) - The
approved route of administration in Australia is IM injection only but the
international label states SC/IM ' 10(5)(h) - The proportion of the active
ingredient in the medicine is not stated
Conditions imposed
This consent applies only to the TYPHIM Vi batch T2A421M' A 'Dear Healthcare
Provider' letter identical to that provided to the TGA with the request
application on 09 March 2020 will be supplied with the affected batchwarning for
batch T2A421M, that the Standard International syringe label does notfully
comply with the Australian labelling requirements.' All other packaging and
labelling of the product, including carton labels andpackage leaflet (Australian
Product Information and Consumer Information)willcomply with current Australian
registered details
Therapeutic product type
Prescription medicines