catridecacog (rys) (NOVOTHIRTEEN) 2500 IU powder for injection vial with diluent vial, Novo Nordisk Pharmaceuticals Pty Ltd, CON-147
Product name
catridecacog (rys) (NOVOTHIRTEEN) 2500 IU powder for injection vial with diluent vial
Sponsor name
Novo Nordisk Pharmaceuticals Pty Ltd
Consent start
Consent no.
CON-147
Standard
Section 10(4)(h) and (i) of Therapeutic Goods Order No 91 '” Standard for labels of prescription and related medicines.
Non-compliance with standard
The powder and solvent vial labels include batch number and expiry date in a
font size less than the minimum 1.5 millimetres (actual font size is 1.32
millimetres). In addition, the powder vial label will contain GTIN barcode in
1.32 millimetre font.
Conditions imposed
This consent applies to labels of the first supply of the product planned
for July 2017 which, due to limitation of the packaging line, the batch number
and expiry date cannot be printed in a larger font size.
Therapeutic product type
Prescription medicines