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PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 250mg/5ml powder for oral liquid bottle , AFT Pharmaceuticals Pty Ltd, CON-1433
Product name
PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 250mg/5ml powder for oral liquid bottle
Sponsor name
AFT Pharmaceuticals Pty Ltd
Consent start
Consent no.
CON-1433
Duration
The consent is effective from 1 December 2025 until 1 December 2026.
Standard
Requirements related to substance test specifications from the monograph for 'Phenoxymethylpenicillin Oral Solution' of British Pharmacopoeia
Non-compliance with standard
The products do not conform because they are unable to meet the requirements of
the British Pharmacopeia with respect to related substances over the shelf life
of the products.
Conditions imposed
The sponsor have proposed to reformulate the products to improve the stability
over the shelf life of the medicine. The sponsor is required to provide an
update of this process by 1 December 2026.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines