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Pfizer (Perth) GENTAMICIN 80mg/2mL (as sulfate) injection BP ampoule, Pfizer Australia Pty Ltd, CON-663
Product name
Pfizer (Perth) GENTAMICIN 80mg/2mL (as sulfate) injection BP ampoule
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-663
Standard
The Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform with the requirements of TGO 91 due to global
supply chain issues in introducing the TGO 91 compliant labels into the
manufacturing process. However, the product is supplied with labels that have
been approved by the TGA, assessed against TGO 69 requirements.
Therapeutic product type
Prescription medicines