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Pfizer (Australia) BUPIVACAINE HYDROCHLORIDE 0.5% (50mg/10mL) injection BP ampoule, Pfizer Australia Pty Ltd, CON-1383
Product name
Pfizer (Australia) BUPIVACAINE HYDROCHLORIDE 0.5% (50mg/10mL) injection BP ampoule
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1383
Duration
The consent is effective from 10 July 2025 until 30 September 2026.
Standard
Paragraphs 10(4)(d); 10(4)(f); 10(4)(g); and 10(4)(k) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because: -The name of the active ingredient in text
less than 2.0mm; - The name of the dosage form does not include the text
‘injection, solution’. - The quantity of the medicine is not presented correctly
- The route of administration is not correctly expressed as 'for infiltration
and/or epidural injection'.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines