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NEBILET nebivolol (as hydrochloride) 5 mg tablet blister pack, A Menarini Australia Pty Ltd, CON-976

Product name
NEBILET nebivolol (as hydrochloride) 5 mg tablet blister pack
Sponsor name
A Menarini Australia Pty Ltd
Consent start
Consent no.
CON-976
Duration
This consent is effective from 1 August 2022 until 31 December 2023.
Standard
The current European Pharmacopeia (Ph. Eur.) monograph for Nebivolol hydrochloride
Non-compliance with standard
The products do not meet the Ph. Eur. monograph for Nebivolol hydrochloride analytical procedures used to determine Assay and Related Substances.
Import, Supply, &/or Export
Import, supply and export
Therapeutic product type
Prescription medicines