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MELAKSO melatonin 3 mg capsule blister pack, Link Medical Products Pty Ltd T/A Link, CON-1176
Product name
MELAKSO melatonin 3 mg capsule blister pack
Sponsor name
Link Medical Products Pty Ltd T/A Link
Consent start
Consent no.
CON-1176
Duration
The consent is effective from 3 October 2023 until 3 April 2025.
Standard
of British Pharmacopoeia
Non-compliance with standard
The drug product expiry specifications state a limit for Any unknown impurities of NMT 0.3%.
The Melatonin Capsules (British Pharmacopoeia 2024) monograph specifies a limit for Any unknown impurities of NMT 0.1%.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines