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FIASP PENFILL insulin aspart (rys) 100 units/mL solution for injection 3 mL cartridge, Novo Nordisk Pharmaceuticals Pty Ltd, CON-324
Product name
FIASP PENFILL insulin aspart (rys) 100 units/mL solution for injection 3 mL cartridge
Sponsor name
Novo Nordisk Pharmaceuticals Pty Ltd
Consent start
Consent no.
CON-324
Standard
Subparagraph 10(3)(a)(iii) of the Therapeutic Goods Order No 91 - Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The primary pack and carton do not express the quantity of each excipient in the
medicine.
Conditions imposed
The products to which this consent applies are those specified in the request
submitted.
Therapeutic product type
Prescription medicines