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RYZODEG 70/30 U100 PENFILL 5X3, Novo Nordisk Pharmaceuticals Pty Ltd, CON-609
Product name
RYZODEG 70/30 U100 PENFILL 5X3
Sponsor name
Novo Nordisk Pharmaceuticals Pty Ltd
Batches
Batch JS69K42
Consent start
Consent no.
CON-609
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
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.
Therapeutic product type
Prescription medicines