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BTC PREGABALIN pregabalin 75mg capsule blister pack, Sandoz Pty Ltd, CON-1260
Product name
BTC PREGABALIN pregabalin 75mg capsule blister pack
Sponsor name
Sandoz Pty Ltd
Batches
NW2224
Consent start
Consent no.
CON-1260
Duration
The consent is effective from 1 August 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 products do not contain the batch prefix preceding the batch number or the
expiry date prefix preceding the expiry date on the blister strip
Conditions imposed
A Dear Pharmacist’ letter identical to that provided to the TGA on 1 August 2024
advising them to remind patients to keep the blister packs with the correctly
labelled carton, must be provided with the affected batch.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines