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
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
1. 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.
2. 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.
Therapeutic product type
Prescription medicines