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SEED PHARMA CARBIMAZOLE 5 carbimazole 5 mg tablet blister pack, Seed Pharma Pty Ltd , CON-897
Product name
SEED PHARMA CARBIMAZOLE 5 carbimazole 5 mg tablet blister pack
Sponsor name
Seed Pharma Pty Ltd
ARTG details
- 349097
Batches
200328, 200329A, 210029, 210030, 210031, 210033, 210035, 210132, 210133, 210134, 210034, and 200337
Consent start
Consent no.
CON-897
Duration
The consent is effective from 17 December 2021 until 31 March 2023 or until the stock is exhausted.
Standard
Subparagraphs 10(14)(a)(iv) and (ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform to the requirements of subparagraphs 10(14)(a)(iv)
and (ix) of Therapeutic Goods Order No. 91 - Standard for labels of prescription
and related medicines in that the blister foils do not state the name of the
medicine and the name or an identifier of the 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 TGA on 26 November 2021.
2. A 'Dear Pharmacist' letter identical to that agreed with the TGA on 7
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