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
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.
Therapeutic product type
Prescription medicines