OZURDEX dexamethasone 700 microgram intravitreal implant, Allergan Australia Pty Ltd, CON-879
Product name
OZURDEX dexamethasone 700 microgram intravitreal implant
Sponsor name
Allergan Australia Pty Ltd
Consent start
Consent no.
CON-879
Standard
Paragraph 9(3)(a) and Subsection 9(5) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of Paragraph 9(3)(a) and
Subsection 9(5) of Therapeutic Goods Order No. 91 '“ Standard for labels of
prescription and related medicines (TGO 91), in that the product does not have
the name and quantity of the active ingredient printed immediately below the
name of the medicine on the applicator pen label, and are printed in a text size
less than 3.0 millimetres in size.
Therapeutic product type
Prescription medicines