RYZODEG 70/30 PENFILL 70% insulin degludec (rys) / 30% insulin aspart (rys) 100 U/mL solution for injection cartridge., Novo Nordisk Pharmaceuticals Pty Ltd, CON-609

The Product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the product label does not comply with the TGO 91 ' the name of the medicine and the name(s) of active ingredient(s) on the main label did not appear as a cohesive unit' the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) did not comply with 'text size of not less than 3.0 millimetres'' for FlexTouch 1 park the statement 'starter pack' or words to that effect is not on the container or primary pack label.' the quantity or proportion of active ingredient is not expressed as the quantity of the active ingredient in one millilitre of the injection.' the quantity or proportion of an active ingredient was not expressed as potency units or weight of active ingredient per dose or per unit volume or as the volume which contains the recommended dose or as IU.