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XIIDRA lifitegrast 50 mg/mL eye drops single-use ampoules, Novartis Pharmaceuticals Australia Pty Ltd, CON-725
Product name
XIIDRA lifitegrast 50 mg/mL eye drops single-use ampoules
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-725
Duration
The consent is effective for all batches of the product released from 12 January 2021 until 12 January 2023.
Standard
Paragraphs 10(12)(c), 10(12)(d), 10(12)(e), 10(12)(f) and subparagraph 10(15)(b)(iv) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The ampoule label does not conform with the requirements of paragraphs
10(12)(c), 10(12)(d), 10(12)(e), 10(12)(f) and subparagraph 10(15)(b)(iv) of
Therapeutic Goods Order No. 91 – Standard for labels of prescription and related
medicines (TGO 91) in that it does not include the following information –
quantity of the medicine; the batch number and the expiry date in the required
format; the approved route of administration for the medicine; and the batch
number and the expiry date are not preceded by a suitable prefix.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines