AVLOIRE carbamazepine 100 mg tablet blister pack, Novartis Pharmaceuticals Australia Pty Ltd , CON-1301
Product name
AVLOIRE carbamazepine 100 mg tablet blister pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Batches
Batches THEE8 and THFD3
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.
Therapeutic product type
Prescription medicines