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PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 125mg/5ml powder for oral liquid bottle, AFT Pharmaceuticals Pty Ltd , CON-1300
Product name
PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 125mg/5ml powder for oral liquid bottle
Sponsor name
AFT Pharmaceuticals Pty Ltd
Consent start
Consent no.
CON-1300
Duration
The consent is effective from 14 November 2024 until 31 December 2025.
Standard
Monograph for Phenoxymethylpenicillin Oral Solution of British Pharmacopoeia
Non-compliance with standard
The products do not meet the requirements of the British Pharmacopeia with
respect to related substances over their shelf life.
Conditions imposed
The sponsor will provide the TGA with the outcome of the discussions with the
British Pharmacopoeia within 2 weeks of receiving information from their expert
committee.
If the discussions with the BP do not lead to a widening of the limits, the
sponsor will be required to provide the TGA with a plan on how you intend of
being compliant. This may consist of safety data to support an extended
exemption to permit the higher levels of the related substances viewed over the
shelf life of the product. This would need to be submitted using the Category 1
pathway. If safety data cannot be generated, consideration for either the
reduction of the shelf life of the products or reformulation of the products is
recommended.
Import, Supply, &/or Export
import, supply, and export
Therapeutic product type
Prescription medicines