WP CARBIMAZOLE 5 carbimazole 5 mg tablet blister pack, Seed Pharma Pty Ltd, CON-916
Product name
WP CARBIMAZOLE 5 carbimazole 5 mg tablet blister pack
Sponsor name
Seed Pharma Pty Ltd
Batches
200328, 200329A, 210029, 210030, 210031, 210033, 210035, 210132, 210133, 210134, 210034 and 200337
Consent start
Consent no.
CON-916
Duration
The consent is effective from 23 February 2022 until 31 March 2023 or until the batches are exhausted.
Standard
Subparagraphs 10(14)(a)(iv) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of subparagraphs 10(14)(a)(iv) and 10(14)(a)(ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), in that the product blister foil labels do not state the name of the medicine and the name or identifier of the Australian sponsor.
Conditions imposed
The blister labels to which this consent applies are those provided with the application and packaged in the Australian approved carton labels as agreed with the Therapeutic Goods Administration on 26 November 2021.A ‘Dear Pharmacist’ letter identical to that agreed with the Therapeutic Goods Administration on 16 December 2021 advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with each of the affected batches.
Import, Supply, &/or Export
Supply
Therapeutic product type
Prescription medicines