Skip to main content

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
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.
Therapeutic product type
Prescription medicines

Help us improve the Therapeutic Goods Administration site