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ZIRCOL 10 lercanidipine hydrochloride 10mg film coated tablet blister pack, Alphapharm Pty Ltd, CON-1412
Product name
ZIRCOL 10 lercanidipine hydrochloride 10mg film coated tablet blister pack
Sponsor name
Alphapharm Pty Ltd
Batches
HC4N34.1
Consent start
Consent no.
CON-1412
Duration
The consent is effective from 23 September 2025 until 31 August 2026.
Standard
Section 8, paragraph 8(1)(f) and paragraph 8(1)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product labels do not conform because the batch number and expiry prefixes
‘LOT’ and ‘EXP’ are omitted from the blister label.
Conditions imposed
A ‘Dear Pharmacist’ letter will be provided with each affected batch, advising
pharmacists to remind patients to keep the blister packs with the correctly
labelled carton.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines