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Pfizer (Australia) GENTAMICIN 80mg/2mL (as sulfate) injection BP ampoule, Pfizer Australia Pty Ltd , CON-1377
Product name
Pfizer (Australia) GENTAMICIN 80mg/2mL (as sulfate) injection BP ampoule
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1377
Duration
The consent is effective from 1 July 2025 until 30 September 2026.
Standard
Paragraphs 10(5)(d) and 10(5)(h) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because print direct stamped onto the plastic
ampoules (TECA print) that means that the space available has prevented the
inclusion of the following requirements: • The quantity of medicine • The name
of the active ingredient and the quantity or proportion of the active ingredient
in the medicine, or suitable unambiguous abbreviation of the name and quantity,
unless the name of the medicine includes this information.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines