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BICILLIN L-A-benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL suspension for injection syringe with needle, Pfizer Australia Pty Ltd, CON-1282

Product name
BICILLIN L-A-benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL suspension for injection syringe with needle
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-1282
Duration
The consent is effective from 16 October 2024 until 6 January 2027.
Standard
current version of the United States Pharmacopeia National Formulary (USP-NF) monograph for ‘Lecithin’ of United States Pharmacopoeia
Non-compliance with standard
The products do not meet the specification for ‘Assay: Content of Phospholipids’ of not less than 70.0% for phosphatidylcholine.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines