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VOQUILY melatonin 3 mg capsule blister pack, Link Medical Products Pty Ltd TA Link Pharmaceuticals, CON-1280
Product name
VOQUILY melatonin 3 mg capsule blister pack
Sponsor name
Link Medical Products Pty Ltd TA Link Pharmaceuticals
Consent start
Consent no.
CON-1280
Duration
The consent is effective from 15 October 2024 until 31 December 2025.
Standard
Melatonin Capsules (British Pharmacopoeia 2024) monograph of British Pharmacopoeia
Non-compliance with standard
The product does not conform to the requirements of the Any unknown impurities limit stated in the Melatonin Capsules (British Pharmacopoeia 2024) monograph. The product expiry specifications stated a limit for Any unknown impurities of not more than 0.3%, whilst the Melatonin Capsules (British Pharmacopoeia 2024) monograph specifies a limit for Any unknown impurities of not more than 0.1%.
Conditions imposed
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines