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CIPLA FOSFOMYCIN fosfomycin (as trometamol) 3 g granules for oral solution sachet, Cipla Australia Pty Ltd, CON-1243
Product name
CIPLA FOSFOMYCIN fosfomycin (as trometamol) 3 g granules for oral solution sachet
Sponsor name
Cipla Australia Pty Ltd
Consent start
Consent no.
CON-1243
Duration
The consent is effective from 31 May 2024 until 31 May 2026.
Standard
Fosfomycin Trometamol monograph of British Pharmacopoeia
Non-compliance with standard
The product(s) control (Z)-1-propenyl-phosphonic acid (olefinic acid) in the drug substance at NMT 0.4%, above the unspecified impurities limit of NMT 0.1%.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines