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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-1060
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
Batches
FT9667, GJ9969 and GM8084
Consent start
Consent no.
CON-1060
Duration
The consent is effective from 6 January 2023 until 6 January 2025.
Standard
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 NLT 70.0% for phosphatidylcholine
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines