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ZADITEN ketotifen 250 microgram/ mL eye drops, solution ampoule, Novartis Pharmaceuticals Australia Pty Ltd, CON-949
Product name
ZADITEN ketotifen 250 microgram/ mL eye drops, solution ampoule
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-949
Duration
The consent is effective from 2 June 2022 until 1 October 2026.
Standard
Subsection 10(7) of the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92)
Non-compliance with standard
The product that does not conform to the requirements of subsection 10(7) of TGO
92 in that the ampoule labels • do not include the quantity of the medicine in
the container, • do not include the name of the sponsor or distributor (or a
registered trademark that readily identifies the sponsor or distributor), and •
do not comply with the text height requirements for small containers.
Import, Supply, &/or Export
Supply
Therapeutic product type
Over-the-counter medicines