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Sunitinib Sandoz sunitinib 25 mg capsule blister, Sandoz Pty Ltd , CON-901
Product name
Sunitinib Sandoz sunitinib 25 mg capsule blister
Sponsor name
Sandoz Pty Ltd
Batches
1XC01A
Consent start
Consent no.
CON-901
Duration
The consent is effective for the aforementioned batches only from 19 January 2022 until 19 January 2024 or until the batches are depleted.
Standard
Paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The products do not conform with the requirements of paragraphs 8(1)(f) and
8(1)(g) of Therapeutic Goods Order No. 91 – Standard for labels of prescription
and related medicines (TGO 91) in that the blister labels do not include batch
and expiry prefixes.
Conditions imposed
A Dear Healthcare Professional letter identical to that provided with the letter
of application dated 9 November 2021 will be supplied with each affected batch.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines