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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-958
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
Batches
CH2830 and EA3123
Consent start
Consent no.
CON-958
Duration
The consent is effective until 17 December 2022.
Standard
United States Pharmacopeia-National Formulary (USP-NF) monograph for ‘Lecithin’
Non-compliance with standard
The products do not conform with the requirements of the current version of the
United States Pharmacopeia-National Formulary (USP-NF) monograph for ‘Lecithin’
because the products do not meet the specification for ‘Assay Content of
Phospholipids’ of NLT 70.0% for phosphatidylcholine.
Import, Supply, &/or Export
Supply
Therapeutic product type
Prescription medicines