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VALOMEL agomelatine (as agomelatine-citric acid) 25 mg tablet blister pack, Helix Pharmaceuticals Pty Ltd, CON-1246
Product name
VALOMEL agomelatine (as agomelatine-citric acid) 25 mg tablet blister pack
Sponsor name
Helix Pharmaceuticals Pty Ltd
Consent start
Consent no.
CON-1246
Duration
The consent is effective from 3 June 2024 until 31 January 2026.
Standard
Subparagraphs 10(14)(a)(vii) and 10(14)(a)(viii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product blister pack does not include the batch number prefix preceding the
batch number or the expiry date prefix preceding the expiry date
Conditions imposed
A Dear Pharmacist’ letter identical to that provided to the TGA on 2 May 2024
advising them to remind patients to keep the blister packs with the correctly
labelled carton, must be provided with each of the affected batches.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines