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TEGRETOL CR 200 carbamazepine 200 mg tablet blister pack, Novartis Pharmaceuticals Australia Pty Ltd , CON-1301
Product name
TEGRETOL CR 200 carbamazepine 200 mg tablet blister pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Batches
Batches TJAR7, TJAR8, TJDH7 and TJCC6
Consent start
Consent no.
CON-1301
Duration
The consent is effective from 25 November 2024 until 31 October 2025.
Standard
Subparagraph 10(14)(c)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product's blister strip label contains perforations that indicate the dosage
unit could be detached, however the information required is written in a manner
that does not appear once in relation to every two dosage forms and is instead
in a diagonal direction across the strips.
Conditions imposed
A ‘Dear Pharmacist’ letter must be provided with each of the affected batches
advising of the risk of the blister perforations.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines