RYZODEG 70/30 FLEXTOUCH 70% insulin degludec (rys) / 30% insulin aspart (rys) 100 U/mL solution for injection cartridge, Novo Nordisk Pharmaceuticals Pty Ltd, CON-733
Product name
RYZODEG 70/30 FLEXTOUCH 70% insulin degludec (rys) / 30% insulin aspart (rys) 100 U/mL solution for injection cartridge
Sponsor name
Novo Nordisk Pharmaceuticals Pty Ltd
Batches
KP52936 KP54360
Consent start
Consent no.
CON-733
Standard
Subparagraph 9(3)(a)(i), subsection 9(5), paragraph 10(10)(b), subparagraphs 11(2)(f)(iv)(A), 11(3)(a)(i), 11(3)(a)(ii) and 11(3)(b)(i) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product label does not comply with the TGO 91 regarding the following
information the name of the medicine and the name(s) of active ingredient(s) on
the main label did not appear as a cohesive unitthe 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