BICILLIN L-A benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL suspension for injection pre-filled syringe with needle, Pfizer Australia Pty Ltd, CON-1282
Product name
BICILLIN L-A benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL suspension for injection pre-filled 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.
Therapeutic product type
Prescription medicines